Syndax Pharmaceuticals
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Syndax Pharmaceuticals, founded in 2005, is a commercial-stage oncology innovator committed to advancing the next generation of targeted treatments to improve the lives of cance
13 Jobs
Director, Oncology Clinical Educator
Syndax PharmaceuticalsSyndax Pharmaceuticals, founded in 2005, is a commercial-stage oncology innovator committed to advancing the next generation of targeted treatments to improve the lives of cance
Role Description The Oncology Clinical Educator will serve as a critical member of the Customer Engagement Team and will have an exciting opportunity within Syndax as we continue to support our FDA approved therapies and bring our pipeline of therapies to market. In this role, the Oncology Clinical Educator (OCE) will be responsible for providing clinical education utilizing approved materials primarily focused on education to oncology patient care teams, including: - Nurses - Nurse navigators - Pharmacists - Other advanced practice providers (APPs), such as Nurse Practitioners and Physician Assistants As Syndax brands grow and utilization expands, the OCE may also spend time providing education to physicians. OCEs will be a trusted educational resource for treatment team members to better understand various aspects of treatment with Syndax Oncology brands. They will help HCPs and their staff understand Syndax Oncology brands through education and approved resources in a defined geographic region. The OCE will serve as the strategic education leader across academic and community oncology accounts, analyzing account dynamics to gain a deep understanding of customer educational objectives and clinical challenges. They will use these insights to develop strategic educational plans. The OCE will determine which approved tools will best engage accounts, monitor the changing market educational needs/clinical trends, and compliantly collaborate with internal/external partners to build/execute plans that support the education needs. The OCE will also play a key role working with various advocacy groups that support the education of patients. They will be a trusted clinical resource for their regional colleagues and will collaborate with Commercial Learning & Development and their regional leader to enhance sales-training initiatives and improve clinical competencies of the field staff. As part of the Customer Engagement team, the OCE is responsible for conducting all activities in accordance with current regulatory and health care compliance guidelines and Syndax policy. Behaviors that are critical for success in this role are: - Collaboration - Communication - Planning - Relationship building - Ability to execute tactical initiatives and provide timely feedback OCEs will report directly to the Senior Regional Director, Oncology Clinical Educator. Qualifications - Bachelor’s degree required - MSN, Advanced Practice Provider (NP/PA), or Pharmacy degree preferred - 8+ years of work experience required - 2+ years post graduate oncology clinical and/or educational experience is required - Experience with Oncology and/or Hematology products required - Excellent presentation skills required - Knowledge and/or experience with direct to patient education initiatives preferred - Previous industry experience preferred - Previous experience in introducing new specialty pharmaceutical/biologics products or indications a plus - Ability to navigate and discuss complex clinical data - Excellent collaboration and time management skills - Excellent communication skills - Demonstrates critical thinking - Ability to analyze clinical insights to shape local education strategy - Strong teamwork focus with ability to compliantly navigate cross functional partner complexities - Above average computer skills: PowerPoint, Excel, Word - Requires travel of approximately 80% depending on geography (includes overnight travel); Other travel for business meetings as required; Travel by air, including overnight and weekends as needed - Must have a valid driver’s license Requirements - Build external relationships with key treatment team members (RN, NP, PA, Pharm.D., Nurse Navigators) within their region - Develop and maintain a strategic regional plan that meets customer educational needs and clinical challenges, through analysis of account dynamics and clinical insights - Educate customers on disease state awareness and unbranded topics pertinent to the disease states worked in - Educate customers on the clinical profile of products including but not limited to clinical benefits and administration requirements - Provide education programs through 1:1 or group presentations, and/or formal presentations - Participate in advocacy initiatives that support the education of patients - Master all aspects of the clinical and administrative profile of new cancer medications - Understand, translate, and communicate relevant clinical education topics to diverse audiences - Utilize strategic questioning and actively listen to routinely document and share clinical insights from customer engagements that take place within accounts or at national, regional, and local meetings - Utilize clinical insights to shape local education strategy and build strategic account educational plans - Attend and provide clinical information and/or presentations at national, regional, and local meetings - Provide staff support, as appropriate at exhibit booths and displays as required - In collaboration with supervisor develop, implement, and document performance and development plan - Participate in select cross-functional projects - Perform all administrative requirements in a timely, accurate and compliant manner (e.g., expense reports, documentation of activities) - Provide national, regional and local support to clinically enhance sales training initiatives and improve clinical competencies of field personnel in partnership with Commercial Learning and Development - Stay current in clinical developments related to specific disease states - Develop and maintain advanced presentation skills to facilitate effective communication - Document all interactions, clinical insights, and customer profile information as directed - Attend clinically relevant meetings for personal/professional development - Maintain the highest level of professional standards in all interactions, internally and externally - Conduct all aspects of the OCE role in accordance with the Syndax Code of Conduct and compliance guidelines Benefits - Total compensation and rewards package that is among the most competitive in the industry - Base pay determined within a range based on several factors including market data, experience, qualifications, demonstrated skills, relevant education or training, travel requirements and internal equity - Overall package includes an equity offering, annual target bonuses, and an outstanding benefits program - Anticipated annualized salary range for this role is $235,000 - $250,000
Executive Director, Clinical Development
Syndax PharmaceuticalsSyndax Pharmaceuticals, founded in 2005, is a commercial-stage oncology innovator committed to advancing the next generation of targeted treatments to improve the lives of cance
Role Description The role will report to the Global Head of Development. The ED Clinical Development is responsible for the creation and execution of clinical development plans within cross-functional project teams (clinical project managers, preclinical/clinical pharmacology, biometrics, regulatory, drug safety). The role will oversee several preclinical and clinical stage assets, with the potential to build a team as the assets evolve and provide clinical input into business development opportunities as needed. They will work closely with key internal and external stakeholders, provide input into global regulatory strategy development and participate in the preparation of submission documents and responses to regulatory agency queries. They will be a strategic leader providing a strong, clear voice for the clinical program. Key Responsibilities - Develops and implements clinical development plans, as well as study protocols in conjunction with a multidisciplinary Development Team. - Represents clinical development with senior internal and external stakeholders. - Provides input and clinical assessment for business development opportunities. - Ensures robust clinical input into TPPs. - Provides robust clinical input into global regulatory strategy, and co-leads interactions with global HA. - Supports the identification and selection of clinical investigators for clinical trials and maintains appropriate communication and professional relationships as Sponsor medical monitor/representative. - Conducts medical assessment and disposition of adverse events (in conjunction with Drug Safety physician) and evaluates safety of clinical compounds prior to and during ongoing clinical studies. - Oversees the clinical trials program in conjunction with Clinical Operations in accordance with NBI SOPs, Good Clinical Practice, and applicable regulations. - Analyzes, interprets, and presents results of clinical studies to internal and external audiences as directed by Sr. Management. - Identifies resource requirements, assists in budget planning and personnel forecasting for clinical research programs. - Assists in the recruitment, training and development of the clinical teams. - Identifies and selects clinical consultants as needed. - Responsible for the scientific writing and review of clinical study reports and related regulatory documents. - Provides periodic status updates and effectively communicates with the Senior Management Team. - Collaborates with translational medicine for the development of clinical biomarker strategies. - Works with Medical Affairs and external opinion leaders to secure new collaborators, presents trial results and shapes IST strategy. - Other duties as assigned. Qualifications - MD or MD/PhD with 5-10 years’ experience in clinical research preferentially in an industry setting. - Sub-specialty training or board certification in hematology, oncology, or related field preferred. - Experience in early development and with designing first in human studies is a plus. - Track record of building CDPs with a cross functional team. - Strong ability to integrate biological knowledge into clinical development strategy. - Strong ability and willingness to work across a broad dynamic range, including interactions with senior internal leaders / supervisory board, while maintaining primary clinical responsibility for study level work. - A creative problem solver with the proven ability to work independently and collaboratively in a fast-paced, results-oriented and dynamic environment. - Recognized as an internal medical leader with extensive technical expertise and demonstrate effectiveness as Clinical Lead on a program, operating in a multi-level matrix corporate environment, requiring interaction with, and/or direction of clinical research project teams, including physicians, scientists, monitors, administrative, regulatory, commercial, and consultant personnel. - Able to manage interactions with external CROs, consultants and other contract organizations, especially from the context of a small group. - Applies in-depth knowledge of own function and scientific expertise to solve critical issues successfully and innovatively. - Ability to evaluate key business / scientific challenges and complete complex, ambiguous initiatives that have cross-functional impact. - Able to work independently and prioritize multiple tasks and goals to ensure programs are delivered on-target and within-budget. - Excellent interpersonal skills and a demonstrated ability to work well within team structure is essential; Strong written and verbal communication skills. - Experience with working in an alliance would be a plus. Location Syndax’s corporate office is in New York, NY. Benefits - Total compensation and rewards package that is among the most competitive in the industry. - Base pay determined within a range based on several factors including market data, experience, qualifications, demonstrated skills, relevant education or training, travel requirements and internal equity. - Overall package includes an equity offering, annual target bonuses, and an outstanding benefits program. - Anticipated annualized salary range for this role is $380,000 - $400,000. Company Description Syndax Pharmaceuticals is a commercial-stage biopharmaceutical company advancing innovative cancer therapies. Highlights of the Company’s pipeline include a menin inhibitor for R/R acute leukemia and a monoclonal antibody that blocks the CSF-1 receptor for chronic graft-versus-host disease. Fueled by our commitment to reimagining cancer care, Syndax is working to unlock the full potential of its pipeline and is conducting several clinical trials across the continuum of treatment. For more information, please visit www.syndax.com or follow the Company on X and LinkedIn. Syndax Pharmaceuticals is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.
Director, Commercial Regulatory Affairs, Labeling, Advertising, and Promotion
Syndax PharmaceuticalsSyndax Pharmaceuticals, founded in 2005, is a commercial-stage oncology innovator committed to advancing the next generation of targeted treatments to improve the lives of cance
Role Description We are currently seeking a qualified, highly motivated, experienced individual for the position of Director, Commercial Regulatory Affairs, Labeling, Advertising, and Promotion to lead labeling activities and the review of promotional materials in commercial regulatory affairs at Syndax for the company’s 2 marketed FDA approved products in acute leukemia and chronic GVHD. The position reports to the Executive Director, Commercial Regulatory Affairs. The Director will: - Lead and provide strategic input and oversight of regulatory labeling activities. - Lead the Labeling Working Group (LWG) meeting to develop an optimal Target Product Label (TPL), U.S. Product Information (USPI) strategy, and EU SmPC when applicable. - Represent RA Labeling as the functional representative across the organizational levels relevant to assigned products and/or other activities. - Manage, oversee, review, and approve the work of more junior staff related to labeling activities. - Serve as a central point of contact and expert for global Regulatory teams in interpreting content and messaging of Company Core Data Sheets (CCDSs) and USPIs. - Act as a key advisor to cross-functional partners, stakeholders, and teams. - Assist with cross-functional meetings involved in the governance and decision-making of regulatory labeling with senior leadership. - Train cross-functional partners and teams on labeling processes, policies, procedures, standards, etc. - Engage business partners for planning and implementation on issues pertaining to product promotion. - Participate in the review and approval of promotional materials under the guidance of the Executive Director, Commercial Regulatory as assigned. - Provide the regulatory aspects for the review and approval process for product promotion materials. - Interact with commercial, medical, and legal on a regular basis. - Influence decision-making processes within the Promotional Review Committee (PRC). Qualifications - BS or BA degree required in life sciences in a relevant discipline. - Advance degree MA/MS, PharmD, or PhD preferred. - At least 8-10 years in pharmaceutical or biotech industry. - At least 6 years in regulatory affairs labeling, advertising, and promotion. - Proficiency in Veeva, Microsoft Word, Excel, PowerPoint, and Adobe Acrobat. - Solid knowledge of U.S. FDA labeling requirements. - Direct experience leading a recent product launch in oncology preferred. - Experience with FDA standards for advertising and promotion compliance. - Strong listening, verbal, and written communication and presentation skills. - Knowledgeable on industry compliance requirements and enforcement trends. - Strong interpersonal communication and leadership skills. - Proven ability to prioritize and manage multiple competing tasks and demands. Requirements - Regularly required to operate standard office equipment. - Ability to work on a computer for extended periods of time. - Regularly required to sit for long periods of time, and occasionally stand and walk. - Regularly required to use hands to operate computer and other office equipment. - Close vision required for computer usage. - Occasionally required to stoop, kneel, climb and lift up to 20 pounds. - Occasional travel required. Benefits - Total compensation and rewards package that is among the most competitive in the industry. - Base pay determined within a range based on several factors including market data, experience, qualifications, and internal equity. - Overall package includes an equity offering, annual target bonuses, and an outstanding benefits program. - Anticipated annualized salary range for this role is $225,000 - $250,000.
Systems of Care Director - Northeast
Syndax PharmaceuticalsSyndax Pharmaceuticals, founded in 2005, is a commercial-stage oncology innovator committed to advancing the next generation of targeted treatments to improve the lives of cance
Syndax Pharmaceuticals is looking for a Systems of Care Director - Northeast At Syndax, we are determined to realize a future in which people with cancer live longer and better than ever before. Syndax Pharmaceuticals is a commercial stage biopharmaceutical company developing an innovative pipeline of cancer therapies. The Role: The Systems of Care Director (SCD) will serve as a critical member of the Customer Engagement Team and will have an exciting opportunity within Syndax’s Systems of Care organization as we prepare for additional indications and future product launches. The Systems of Care Director (SCD) is charged with embedding Syndax within some of the most influential healthcare systems across the United States. The Syndax SCD role is best described as a hybrid Thought Leader Liaison (TLL)/Regional Marketer (RM) and Precision Medicine Executive. Syndax SCDs are responsible for system wide initiatives, serve as extensions of the brand team for regional “Insights mining”, and KOL management. The Systems of Care Director must possess a high level of clinical and customer knowledge. They must have experience with both field and headquarters protocols/procedures. Additionally, they should have experience engaging healthcare professionals to build educational platforms that inform the execution of current and future brand/disease-state strategies. The SCD will work closely with national and regional Hematology/Oncology Key Opinion Leaders (KOLs) to ensure Syndax’s cross-functional commercial strategy is understood and resourced appropriately. In addition to Customer Engagement and Commercial Learning & Development personnel, the SCD will work in close collaboration with field and home office-based stakeholders in Marketing, Commercial Operations & Analytics, Market Access & Trade, Medical Science/Affairs, and Legal & Compliance, among others. Behaviors that are critical for success in this role are collaboration, communication, planning, relationship building, and the ability to execute tactical initiatives and provide timely feedback. SCDs will report to the National Senior Director, Systems of Care. Key Responsibilities: - Work closely with multiple Syndax stakeholders inside and outside the commercial organization to ensure strategic alignment and execution of key strategies/tactics to advance overall business objectives. - Partner with external HCP stakeholders at key healthcare systems across the US to ensure seamless access/availability to Syndax treatments post-FDA approval. - Identify, profile, cultivate and maintain long-term relationships with KOLs within the Hematology/Oncology community. - Plan and execute KOL engagements and executive encounters at local, regional, and national conferences; POAs; field visits, and other venues in a compliant manner. - Identify and prioritize novel programming, venues, etc. where Syndax should invest to advance overall business objectives. - Develop and foster an environment where the overall patient, caregiver, and HCP customer experience are prioritized. - Become embedded in target healthcare systems by differentiating themselves from competitors through delivering consistent value. - Adapt quickly to needs/adjustments necessitated by launch preparations and contribute to supporting both corporate and field-based colleagues in navigating a dynamic and evolving market to achieve and exceed expected results in a complex specialty environment. - Partner cross-functionally with internal stakeholders to execute / pull-through business plans and serve as a critical member of the Customer Engagement team. - Develop and maintain all account/contact details within CRM. - Ensure budgets and schedules meet corporate requirements. - Incorporate all appropriate regulatory and legal compliance into daily activities and business practices. Desired Experience/Education and Personal Attributes: - BA/BS or healthcare equivalent degree required. - Minimum 8+ years of previous pharmaceutical, biotech, and/or medical experience with a strong knowledge of the pharmaceutical marketplace and deep understanding of industry and broader trends in the healthcare landscape. - Minimum of 5+ years as a Thought Leader Liaison or Regional Marketer with combined experience in Hematology/Oncology. - Proven ability to access and influence C/D-Suite level customers. - Collaborative and organizationally savvy team player with a history of success in a matrixed setting. - Strong negotiation, partnering, and influencing skills; demonstrated ability to effectively manage business relationships with external strategic partners. - Prior experience working in large accounts and/or hospitals required. Expert at navigating complexities and removing barriers to advance corporate objectives in service of patients, caregivers, and HCPs. - Successful product launch experience required. - Prior pharma/biotech start-up experience preferred. - Technologically savvy and committed to leveraging data and advanced analytics daily to drive business results. - Ability to travel on a frequent overnight basis, with occasional weekend travel, depending on business needs. - Must possess a valid driver’s license and have reliable access to a personal vehicle for travel as required by the role. Location: Syndax’s corporate office is in New York, NY. Northeast Territory: NY, MA, CT, NJ, PA, NH, VT New York, NY, Boston, MA, New Haven, CT, Philadelphia, PA, Pittsburgh, PA, Newark, NJ Syndax offers a total compensation and rewards package that is among the most competitive in the industry. Base pay is just one element of our package and is determined within a range based on several factors including market data, experience, qualifications, demonstrated skills, relevant education or training, travel requirements and internal equity. Our overall package also includes an equity offering, annual target bonuses, and an outstanding benefits program. The anticipated annualized salary range for this role is $250,000 - $270,000. #regionalmarketer #TLL #thoughtleaderliaison #hematology #oncology #mdanderson About Syndax: Syndax Pharmaceuticals is a commercial-stage biopharmaceutical company advancing innovative cancer therapies. Highlights of the Company’s pipeline include a menin inhibitor for R/R acute leukemia and a monoclonal antibody that blocks the CSF-1 receptor for chronic graft-versus-host disease. Fueled by our commitment to reimagining cancer care, Syndax is working to unlock the full potential of its pipeline and is conducting several clinical trials across the continuum of treatment. For more information, please visit www.syndax.com/ or follow the Company on X and LinkedIn. Syndax Pharmaceuticals is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law. #LI-Remote
Director, Oncology Clinical Educator - Northeast/MidAtlantic
Syndax PharmaceuticalsSyndax Pharmaceuticals, founded in 2005, is a commercial-stage oncology innovator committed to advancing the next generation of targeted treatments to improve the lives of cance
Syndax Pharmaceuticals is looking for a Director, Oncology Clinical Educator - Northeast/MidAtlantic At Syndax, we are determined to realize a future in which people with cancer live longer and better than ever before. Syndax Pharmaceuticals is a commercial stage biopharmaceutical company developing an innovative pipeline of cancer therapies. The Role: The Oncology Clinical Educator will serve as a critical member of the Customer Engagement Team and will have an exciting opportunity within Syndax as we continue to support our FDA approved therapies and bring our pipeline of therapies to market. In this role, the Oncology Clinical Educator (OCE) will be responsible for providing clinical education utilizing approved materials primarily focused on education to oncology patient care teams, including nurses, nurse navigators, pharmacists, and other advanced practice providers (APPs), such as Nurse Practitioners and Physician Assistants. As Syndax brands grow and utilization expands, the OCE may also spend time providing education to physicians. OCEs will be a trusted educational resource for treatment team members to better understand various aspects of treatment with Syndax Oncology brands. OCEs will help HCPs and their staff understand Syndax Oncology brands through education and approved resources in a defined geographic region. The OCE will serve as the strategic education leader across academic and community oncology accounts. The OCE will analyze account dynamics to gain a deep understanding of customer educational objectives and customer clinical challenges. The OCE will use these insights to develop strategic educational plans. The OCE will determine which approved tools will best engage accounts, monitor the changing market educational needs/clinical trends, and compliantly collaborate with internal/external partners to build/execute plans that support the education needs. The OCE will also play a key role working with various advocacy groups that support the education of patients. The OCE will be a trusted clinical resource for their regional colleagues and will collaborate with Commercial Learning & Development and their regional leader to enhance sales-training initiatives and improve clinical competencies of the field staff. As part of the Customer Engagement team, the OCE is responsible for conducting all activities in accordance with current regulatory and health care compliance guidelines and Syndax policy. Behaviors that are critical for success in this role are collaboration, communication, planning, relationship building, and the ability to execute tactical initiatives and provide timely feedback. OCEs will report directly to the Senior Regional Director, Oncology Clinical Educator. Key Responsibilities: - Build external relationships with key treatment team members (RN, NP, PA, Pharm.D., Nurse Navigators) within their region - Develop and maintain a strategic regional plan that meets customer educational needs and clinical challenges, through analysis of account dynamics and clinical insights - Educate customers on disease state awareness and unbranded topics pertinent to the disease states worked in - Educate customers on the clinical profile of products including but not limited to clinical benefits and administration requirements - Provide education programs through 1:1 or group presentations, and/or formal presentations - Participate in advocacy initiatives that support the education of patients - Master all aspects of the clinical and administrative profile of new cancer medications - Understand, translate, and communicate relevant clinical education topics to diverse audiences - Utilize strategic questioning and actively listen to routinely document and share clinical insights from customer engagements that take place within accounts or at national, regional, and local meetings - Utilize clinical insights to shape local education strategy and build strategic account educational plans - Attend and provide clinical information and/or presentations at national, regional, and local meetings - Provide staff support, as appropriate at exhibit booths and displays as required - In collaboration with supervisor develop, implement, and document performance and development plan - Participate in select cross-functional projects - Perform all administrative requirements in a timely, accurate and compliant manner (e.g., expense reports, documentation of activities) - Provide national, regional and local support to clinically enhance sales training initiatives and improve clinical competencies of field personnel in partnership with Commercial Learning and Development - Stay current in clinical developments related to specific disease states - Develop and maintain advanced presentation skills to facilitate effective communication - Document all interactions, clinical insights, and customer profile information as directed - Attend clinically relevant meetings for personal/professional development - Maintains the highest level of professional standards in all interactions, internally and externally - Conducts all aspects of the OCE role in accordance with the Syndax Code of Conduct and compliance guidelines Desired Experience/Education and Personal Attributes: - Bachelor’s degree required - MSN, Advanced Practice Provider (NP/PA), or Pharmacy degree preferred - 8+ years of work experience required - 2+ years post graduate oncology clinical and/or educational experience is required - Experience with Oncology and/or Hematology products required - Excellent presentation skills required - Knowledge and/or experience with direct to patient education initiatives preferred - Previous industry experience preferred - Previous experience in introducing new specialty pharmaceutical/biologics products or indications a plus - Ability to navigate and discuss complex clinical data - Excellent collaboration and time management skills - Excellent communication skills - Demonstrates critical thinking - Ability to analyze clinical insights to shape local education strategy - Strong teamwork focus with ability to compliantly navigate cross functional partner complexities - Above average computer skills: PowerPoint, Excel, Word - Requires travel of approximately 80% depending on geography (includes overnight travel); Other travel for business meetings as required; Travel by air, including overnight and weekends as needed - Must possess a valid driver's license and have reliable access to a personal vehicle for travel as required by the role. Location: Syndax has an office in New York City and has a dispersed workforce across the United States. This role would cover a territory including all or portions of Eastern and Central Pennsylvania, New Jersey, New York, Maryland, Delaware, and Washington, DC. Syndax offers a total compensation and rewards package that is among the most competitive in the industry. Base pay is just one element of our package and is determined within a range based on several factors including market data, experience, qualifications, demonstrated skills, relevant education or training, travel requirements and internal equity. Our overall package also includes an equity offering, annual target bonuses, and an outstanding benefits program. The anticipated annualized salary range for this role is $235,000 - $250,000. About Syndax: Syndax Pharmaceuticals is a commercial-stage biopharmaceutical company developing an innovative pipeline of cancer therapies. Highlights of the Company's pipeline include Revuforj® (revumenib), an FDA-approved menin inhibitor, and Niktimvo™ (axatilimab-csfr), an FDA-approved monoclonal antibody that blocks the colony stimulating factor 1 (CSF-1) receptor. Fueled by our commitment to reimagining cancer care, Syndax is working to unlock the full potential of its pipeline and is conducting several clinical trials across the continuum of treatment. For more information, please visit www.syndax.com/ or follow the Company on X (formerly Twitter) and LinkedIn. Syndax Pharmaceuticals is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law. #LI-Remote
Oncology Account Manager – Michigan
Syndax PharmaceuticalsSyndax Pharmaceuticals, founded in 2005, is a commercial-stage oncology innovator committed to advancing the next generation of targeted treatments to improve the lives of cance
Syndax Pharmaceuticals is looking for an Oncology Account Manager – Michigan At Syndax, we are determined to realize a future in which people with cancer live longer and better than ever before. Syndax Pharmaceuticals is a commercial stage biopharmaceutical company developing an innovative pipeline of cancer therapies. The Role: The Oncology Account Manager will serve as a critical member of the Customer Engagement Team and will have an exciting opportunity within Syndax to build on the momentum of the successful launches of our first 2 products. The OAM will be responsible for meeting sales targets and utilizing all available resources while tailoring them to meet the customer's needs through a deep understanding of their requirements. Behaviors that are critical for success in this role are collaboration, communication, planning, relationship building, and the ability to execute tactical initiatives and provide timely feedback. OAMs will report directly to the Regional Business Director. Key Responsibilities: The OAM will achieve territory sales by utilizing their experience to: - Holistically support and manage territory accounts by creating relationships with physicians, allied healthcare professionals (Advanced Practitioners, Nurses, Pharmacists), and business stakeholders (CFOs, Office Practice Managers, Billers, etc.) - Maintain a uniquely deep and nuanced understanding of territory, including Opinion Leaders (OL) and other influencers, treatment and utilization trends, payer and reimbursement dynamics, and competitive opportunities and challenges. - Analyze business performance: Create and execute a comprehensive territory plan. This includes developing unique account plans, delivering branded sales messages, executing planned programs, scheduling and following up with medical education programs, and achieving or exceeding sales targets. - Demonstrate clinical/disease/product expertise and deliver strategic customer education. - Work closely with multiple Syndax internal stakeholders inside and outside the commercial organization to ensure strategic alignment and execution of key strategies/tactics to advance overall business objectives. - Implement processes for appropriate patient identification and treatment management. - Utilize internal relationships and develop external relationships with account stakeholders, including, but not limited to, HCPs and advanced practice providers, to service and manage accounts. - Have passion for our products through the entire sales cycle while always building our brand and never losing sight of how we serve humans. - Leverage your passion for Oncology/disease state awareness, industry, regulatory, and competitive changes to deliver agreed results. Desired Experience/Education and Personal Attributes: - Ideal candidates have strong clinical selling skills, excellent communication/presentation skills, effective working in teams and self-starters, as well as strategic and forward thinking. - BA/BS or healthcare equivalent degree required. - Minimum 5+ years of previous pharmaceutical, biotech, and/or medical sales experience with a strong preference for Oncology/Hematology. - Knowledge of the pharmaceutical marketplace and deep understanding of industry and broader trends in the healthcare landscape. - Collaborative and organizationally savvy team player with a history of success in a matrixed setting. - Strong negotiation, partnering, and influencing skills. - Demonstrated ability to effectively manage business relationships with external strategic partners. - Prior experience working in large accounts and/or hospitals required. Expert at navigating complexities and removing barriers to advance corporate objectives in service of patients, caregivers, and HCPs. - Successful product launch experience required. - Prior pharma/biotech start-up experience preferred. - Technologically savvy and committed to leveraging data and advanced analytics daily to drive business results. - Ability to travel on a frequent overnight basis, with occasional weekend travel, depending on business needs. - Must possess a valid driver's license and have reliable access to a personal vehicle for travel as required by the role. - Location: Syndax’s corporate office is in New York, NY. Syndax offers a total compensation and rewards package that is among the most competitive in the industry. Base pay is just one element of our package and is determined within a range based on several factors including market data, experience, qualifications, demonstrated skills, relevant education or training, travel requirements and internal equity. Our overall package also includes an equity offering, annual target bonuses, and an outstanding benefits program. The anticipated annualized salary range for this role is $215,000 - $230,000. About Syndax: Syndax Pharmaceuticals is a commercial-stage biopharmaceutical company advancing innovative cancer therapies. Highlights of the Company’s pipeline include a menin inhibitor for R/R acute leukemia and a monoclonal antibody that blocks the CSF-1 receptor for chronic graft-versus-host disease. Fueled by our commitment to reimagining cancer care, Syndax is working to unlock the full potential of its pipeline and is conducting several clinical trials across the continuum of treatment. For more information, please visit www.syndax.com/ or follow the Company on X and LinkedIn. Syndax Pharmaceuticals is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law. #LI-Remote
Director, Clinical Data Management
Syndax PharmaceuticalsSyndax Pharmaceuticals, founded in 2005, is a commercial-stage oncology innovator committed to advancing the next generation of targeted treatments to improve the lives of cance
Syndax Pharmaceuticals is looking for a Director, Clinical Data Management At Syndax, we are determined to realize a future in which people with cancer live longer and better than ever before. Syndax Pharmaceuticals is a commercial stage biopharmaceutical company developing an innovative pipeline of cancer therapies. The Role: This position is a strategic leader responsible for overseeing the design, implementation, and oversight of clinical data systems and processes across multiple clinical development programs. This role directs a team in delivering high-quality clinical data in alignment with regulatory requirements, corporate goals, and operational efficiency. The Director contributes to the long-term success of the function through data-driven strategies, innovation in systems and processes, and strong cross-functional partnerships. May also be responsible for projects that have been contracted with a service provider, as well as internal projects. Key Responsibilities: - Collaborate with senior leadership to define and implement functional and organizational strategy aligned with corporate objectives; participate in long-term planning and policy development. - Development and execution of data quality strategies, risk-based data review plans, and cross-study harmonization. - Direct the design, testing, validation, and maintenance of clinical databases and electronic data capture (EDC) systems. - Ensure consistent application of CDM standards, tools (e.g., CDISC, Medidata Rave), and procedures. - Oversee issue resolution and data integrity across outsourced vendors and internal teams. - Provide proactive input into clinical protocol design to ensure data collection strategies align with scientific and regulatory requirements. - Review and contribute to clinical protocols and statistical analysis plans to ensure alignment with data collection objectives; cross-project consistency and standardization of case report forms. - Partner with internal stakeholders to align timelines and data delivery requirements. - Participate in cross-functional study teams; influence protocol design, study setup, and data strategy from study start to submission. - Actively support submission readiness, including data integration and final deliverables for regulatory filings. - Participate in protocol development, clinical study reports (CSR), and submission activities. - Manage relationships with CROs and third-party vendors, ensuring alignment with contractual deliverables and performance expectations. - Establish standards and oversight processes for EDC setup, CRF development, data validation, discrepancy management, and database lock. - Drive consistency and scalability through implementation of standards (e.g., CDISC/CDASH/SDTM) and SOPs. - Development and improvement of clinical data management processes and tools. - Lead and mentor Clinical Data Managers; provide coaching and foster a high-performing and collaborative environment. - Participates in the evaluation of organizational needs, defining resource strategies, and managing departmental budgets and headcount planning. Desired Experience/Education and Personal Attributes: - Bachelor’s degree in related scientific discipline; advanced degree preferred. - 12+ years of progressive experience in clinical data management with leadership responsibility at a sponsor organization. - Expert knowledge of clinical data management. - Deep expertise of industry standards including CDISC/CDASH, SDTM, ICH-GCP, 21 CFR Part 11, and regulatory submission requirements. - Proven success leading large-scale global studies, vendor oversight and working in both in-house and outsourced models. - Expertise knowledge and hands on experience with EDC systems (e.g., Medidata Rave, Veeva), clinical systems integration, and risk-based monitoring frameworks required. - Exceptional leadership, analytical, and communication skills with the ability to influence senior stakeholders and executives. Location: Syndax’s corporate office is in New York, NY. Syndax offers a total compensation and rewards package that is among the most competitive in the industry. Base pay is just one element of our package and is determined within a range based on several factors including market data, experience, qualifications, demonstrated skills, relevant education or training, travel requirements and internal equity. Our overall package also includes an equity offering, annual target bonuses, and an outstanding benefits program. The anticipated annualized salary range for this role is: $220,000 - 250,000. About Syndax: Syndax Pharmaceuticals is a commercial-stage biopharmaceutical company advancing innovative cancer therapies. Highlights of the Company’s pipeline include a menin inhibitor for R/R acute leukemia and a monoclonal antibody that blocks the CSF-1 receptor for chronic graft-versus-host disease. Fueled by our commitment to reimagining cancer care, Syndax is working to unlock the full potential of its pipeline and is conducting several clinical trials across the continuum of treatment. For more information, please visit www.syndax.com/ or follow the Company on X and LinkedIn. Syndax Pharmaceuticals is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law. #LI-REMOTE
Director, Regulatory Strategy
Syndax PharmaceuticalsSyndax Pharmaceuticals, founded in 2005, is a commercial-stage oncology innovator committed to advancing the next generation of targeted treatments to improve the lives of cance
Syndax Pharmaceuticals is looking for a Director, Regulatory Strategy At Syndax, we are determined to realize a future in which people with cancer live longer and better than ever before. Syndax Pharmaceuticals is a commercial stage biopharmaceutical company developing an innovative pipeline of cancer therapies. The Role: The Director, Regulatory Strategy will be responsible for developing and implementing regulatory strategies to secure global investigational and marketing applications for assigned product(s) in the assigned therapeutic area. Leads the Product Regulatory Sub team. Ensures strategic messaging and content of global regulatory dossiers. May serve as the primary regulatory interface with the Asset Strategy Team and sub teams. Proactively anticipates and mitigates regulatory risks. Ensures compliance with global regulatory requirements. Manages assets through all phases of development from pre-FIH through active life cycle management activities. Demonstrates an understanding of drug development and exhibits leadership behaviors consistent with level. Has direct experience with regulatory acceleration strategies, developing regulatory strategy, analyzing regulatory precedence and operational excellence in execution of regulatory strategy. This role may lead a team of regulatory professionals. Key Responsibilities: - Ensure the development and flawless execution of regulatory strategies for the assigned products/projects. - Strategic partner for internal cross functional stakeholders both within and external to the regulatory organization.. - Represents Syndax to regulatory health authorities, e.g. FDA, for all products and businesses. - Lead the preparation of submissions, which may include INDs, Briefing Documents, Orphan Drug Applications, and Marketing Applications, etc. Work with cross-functional groups to define contributions to submissions. Lead regulatory submission teams for projects assigned. - Prepare company team for health agency meetings, as required. - Serve as the primary interface with Regulatory CROs for coordination and preparation of submissions. - Responsible for maintaining a working knowledge of the global regulatory environment in relevant disease areas and identify and communicate the implications of identified regulatory trends that may impact the business. - Maintain knowledge of global competitive landscape, regulatory environment, regulations and guidance. - Prepare, plan and implement new processes and policies to improve efficiency of the Company. Desired Experience/Education and Personal Attributes: - Bachelor’s degree in scientific discipline; advanced scientific degree preferred (PharmD, Ph.D, MD). - Regulatory Affairs Certification is highly desirable. - 8+ years pharmaceutical industry experience, including 5+ years in Regulatory Affairs leadership roles; Global experience desired. - Requires innovator drug development experience in the US and EU/UK/EEA. Experience in Asia PAC, a plus. - Proven 5+ years in a strategic leadership role with strong project management skills. - Experience working in a complex and matrix environment. - Experience directly interfacing with health authorities in a major market. - Experience in multiple phases of development is required. - Experience in rare disease, immunology or oncology is highly desirable. - Knowledge of the drug development process and global submission process. - Knowledge of global regulatory guidance as they relate to the overall global regulatory strategy. - Cross functional partnering skills, team-oriented and ability to influence outcomes are necessary skills in the environment. - Excellent organizational, communication and time management skills needed to manage multiple ongoing projects simultaneously. - Experience working within corporate partnerships is a plus. - Must be able to innovate, analyze and solve problems with minimal supervision and attention to detail. Location: Syndax’s corporate office is in New York, NY. Syndax offers a total compensation and rewards package that is among the most competitive in the industry. Base pay is just one element of our package and is determined within a range based on several factors including market data, experience, qualifications, demonstrated skills, relevant education or training, travel requirements and internal equity. Our overall package also includes an equity offering, annual target bonuses, and an outstanding benefits program. The anticipated annualized salary range for this role is $225,000 - $250,000. About Syndax: Syndax Pharmaceuticals is a commercial-stage biopharmaceutical company advancing innovative cancer therapies. Highlights of the Company’s pipeline include a menin inhibitor for R/R acute leukemia and a monoclonal antibody that blocks the CSF-1 receptor for chronic graft-versus-host disease. Fueled by our commitment to reimagining cancer care, Syndax is working to unlock the full potential of its pipeline and is conducting several clinical trials across the continuum of treatment. For more information, please visit www.syndax.com/ or follow the Company on X and LinkedIn. Syndax Pharmaceuticals is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law. #LI-Remote
Oncology Account Manager – Detroit, MI
Syndax PharmaceuticalsSyndax Pharmaceuticals, founded in 2005, is a commercial-stage oncology innovator committed to advancing the next generation of targeted treatments to improve the lives of cance
Syndax Pharmaceuticals is looking for an Oncology Account Manager – Detroit, MI At Syndax, we are determined to realize a future in which people with cancer live longer and better than ever before. Syndax Pharmaceuticals is a commercial stage biopharmaceutical company developing an innovative pipeline of cancer therapies. The Role: The Oncology Account Manager will serve as a critical member of the Customer Engagement Team and will have an exciting opportunity within Syndax to build on the momentum of the successful launches of our first 2 products. The OAM will be responsible for meeting sales targets and utilizing all available resources while tailoring them to meet the customer's needs through a deep understanding of their requirements. Behaviors that are critical for success in this role are collaboration, communication, planning, relationship building, and the ability to execute tactical initiatives and provide timely feedback. OAMs will report directly to the Regional Business Director. Key Responsibilities: The OAM will achieve territory sales by utilizing their experience to: - Holistically support and manage territory accounts by creating relationships with physicians, allied healthcare professionals (Advanced Practitioners, Nurses, Pharmacists), and business stakeholders (CFOs, Office Practice Managers, Billers, etc.) - Maintain a uniquely deep and nuanced understanding of territory, including Opinion Leaders (OL) and other influencers, treatment and utilization trends, payer and reimbursement dynamics, and competitive opportunities and challenges. - Analyze business performance: Create and execute a comprehensive territory plan. This includes developing unique account plans, delivering branded sales messages, executing planned programs, scheduling and following up with medical education programs, and achieving or exceeding sales targets. - Demonstrate clinical/disease/product expertise and deliver strategic customer education. - Work closely with multiple Syndax internal stakeholders inside and outside the commercial organization to ensure strategic alignment and execution of key strategies/tactics to advance overall business objectives. - Implement processes for appropriate patient identification and treatment management. - Utilize internal relationships and develop external relationships with account stakeholders, including, but not limited to, HCPs and advanced practice providers, to service and manage accounts. - Have passion for our products through the entire sales cycle while always building our brand and never losing sight of how we serve humans. - Leverage your passion for Oncology/disease state awareness, industry, regulatory, and competitive changes to deliver agreed results. Desired Experience/Education and Personal Attributes: - Ideal candidates have strong clinical selling skills, excellent communication/presentation skills, effective working in teams and self-starters, as well as strategic and forward thinking. - BA/BS or healthcare equivalent degree required. - Minimum 5+ years of previous pharmaceutical, biotech, and/or medical sales experience with a strong preference for Oncology/Hematology. - Knowledge of the pharmaceutical marketplace and deep understanding of industry and broader trends in the healthcare landscape. - Collaborative and organizationally savvy team player with a history of success in a matrixed setting. - Strong negotiation, partnering, and influencing skills. - Demonstrated ability to effectively manage business relationships with external strategic partners. - Prior experience working in large accounts and/or hospitals required. Expert at navigating complexities and removing barriers to advance corporate objectives in service of patients, caregivers, and HCPs. - Successful product launch experience required. - Prior pharma/biotech start-up experience preferred. - Technologically savvy and committed to leveraging data and advanced analytics daily to drive business results. - Ability to travel on a frequent overnight basis, with occasional weekend travel, depending on business needs. - Must possess a valid driver's license and have reliable access to a personal vehicle for travel as required by the role. - Location: Syndax’s corporate office is in New York, NY. Syndax offers a total compensation and rewards package that is among the most competitive in the industry. Base pay is just one element of our package and is determined within a range based on several factors including market data, experience, qualifications, demonstrated skills, relevant education or training, travel requirements and internal equity. Our overall package also includes an equity offering, annual target bonuses, and an outstanding benefits program. The anticipated annualized salary range for this role is $215,000 - $230,000. About Syndax: Syndax Pharmaceuticals is a commercial-stage biopharmaceutical company advancing innovative cancer therapies. Highlights of the Company’s pipeline include a menin inhibitor for R/R acute leukemia and a monoclonal antibody that blocks the CSF-1 receptor for chronic graft-versus-host disease. Fueled by our commitment to reimagining cancer care, Syndax is working to unlock the full potential of its pipeline and is conducting several clinical trials across the continuum of treatment. For more information, please visit www.syndax.com/ or follow the Company on X and LinkedIn. Syndax Pharmaceuticals is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law. #LI-Remote
Contractor, Clinical Trial Associate
Syndax PharmaceuticalsSyndax Pharmaceuticals, founded in 2005, is a commercial-stage oncology innovator committed to advancing the next generation of targeted treatments to improve the lives of cance
Syndax Pharmaceuticals is looking for a Contractor, Clinical Trial Associate. At Syndax, we are determined to realize a future in which people with cancer live longer and better than ever before. Syndax Pharmaceuticals is a commercial stage biopharmaceutical company developing an innovative pipeline of cancer therapies. The Role: The CTA will work with Clinical Operations team to support the conduct of clinical trials. The CTA may provide support for various clinical trials and may manage certain aspects of the clinical trials. The CTA will partner with the Clinical Project Managers and Clinical Trial Managers to ensure studies are completed on time, within budget, and in compliance with SOPs, FDA regulations and ICH/GCP guidelines. Key Responsibilities: - Maintain the Trial Master Files (TMF): Responsible for the on-going management of the TMF for assigned clinical trials. This is inclusive of receipt, review, QC, tracking and filing of all documents per the Syndax SOPs required within the conduct of assigned clinical trials. - Ensure TMF is inspection ready. - Provide TMF metrics to internal and external stakeholders. - Work closely with all cross functions to adhere to the trial master oversight plan. - Assist with the development and maintenance of tracking tools for patient recruitment, site ramp-up, monitoring visits and site payments. - Work with Clinical Operations to assist in the oversight of CROs, as appropriate, to ensure the successful conduct of clinical trials, including attending and participating in Clinical Trial Working Groups as needed. - Assist in reviewing monitoring visit reports to ensure proper conduct and oversight as needed. - Review site-specific Informed Consent Forms. - Track site feasibility questionnaires. - Assist in the planning of various meetings and events for the Clinical Operations Team. - Reconcile invoices to their corresponding contracts and budget and assist with investigator site payments. - Prepare and manages study communications including newsletters and study updates. - Records, prepares and distributes meeting minutes for assigned clinical trials or as designated by the VP of Clinical Operations. - Work closely with Clinical Trial Managers to assist with preparation of all external and internal documentation for assigned trials to ensure it's completed in accordance with GCP regulatory requirements and consistent with the study protocol. Desired Experience/Education and Personal Attributes: - Two years’ experience in Veeva Vault. - Two or more years’ experience in clinical operations- experience in both a CRO and Sponsor setting desired. - Knowledge of FDA regulatory requirements and ICH/GCP guidelines essential. - Demonstrated efficiency in partnering with CROs and vendors. - Computer proficiency (Veeva TMF, Word, Excel, PowerPoint, Smart Sheet). - Work proactively and efficiently in a fast-paced, high change environment. - Excellent written and oral communication skills. - Outstanding organization skills. - Bachelor's degree desired, preferably in a science or healthcare related discipline. Location: While our corporate headquarters are located in New York City, this position is open to candidates from any location with a preference for east coast locations. About Syndax: Syndax Pharmaceuticals is a commercial-stage biopharmaceutical company advancing innovative cancer therapies. Highlights of the Company’s pipeline include a menin inhibitor for R/R acute leukemia and a monoclonal antibody that blocks the CSF-1 receptor for chronic graft-versus-host disease. Fueled by our commitment to reimagining cancer care, Syndax is working to unlock the full potential of its pipeline and is conducting several clinical trials across the continuum of treatment. For more information, please visit www.syndax.com/ or follow the Company on X and LinkedIn. Syndax Pharmaceuticals is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law. #LI-REMOTE
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