Ipsen

Title: Patient Access Manager, Rare Disease Location: Boston Job Description: About Ipsen: Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Supported by nearly 100 years of development experience, with global hubs in the U.S., France and the U.K, we tackle areas of high unmet medical need through research and innovation. Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries. We build a workplace that champions human-centric leadership and fosters a culture of collaboration, excellence and impact. At Ipsen, every individual is empowered to be their true selves, grow and thrive alongside the company’s success. Join us on our journey towards sustainable growth, creating real impact on patients and society! The Patient Access Manager, Rare Diseases is part of the Patient Services, Value and Access organization. The purpose of this team is to ensure seamless, patient-centric support to help patients have access to appropriate education and support to start and continue prescribed therapy with Ipsen products where appropriate. This role include working directly with patients, HCP offices, Payers, and Specialty Pharmacies on a one-on-one basis to ensure that patients have an appropriate understanding of complex reimbursement issues, their insurance options and limitations, benefits, and requirements necessary to initiate and maintain prescribed therapy. This function also helps ensure the prompt shipment of products to eligible patients. This is not a promotional selling role. This is a highly skilled support role requiring appropriate coordination with other Ipsen teams (Medical, Clinical, Regulatory, Quality, Compliance, Marketing, Market Access and Pricing, Patient Education Liaison Team, Field Access Director and other field-based colleagues) to help patients throughout their journey in a most appropriate, compassionate, ethical, and compliant way. This role requires strong customer-service and solution-orientation mindsets. The Patient Access Manager, as all other employees, is fully accountable for compliance with all laws, regulations and policies that govern the conduct of Ipsen activities. This role is a remote position with travel (when necessary), with preference for candidates located in the Greater Boston area. WHAT - Main Responsibilities & Technical Competencies Responsibilities include, but are not limited to the following: - Support appropriate patient access for Ipsen products by providing timely and appropriate reimbursement information related to coverage across all payers. - Help providers, patients, and caregivers understand complex reimbursement issues, insurance options and limitations, benefits, and requirements necessary to initiate and maintain therapy as prescribed. - Collaborate with the Ipsen Value & Access home office, sales teams, brand teams, and to expand access and/or reduce barriers to access for Ipsen products. - Work directly with Field Access Director to resolve complex access questions in a timely manner - Coordinate with others to ensure appropriate product supply/delivery. - Support strategic analysis and planning related to changes in local payer coverage policies. - Ability to understand local/regional payer trends and policies. - Help troubleshoot and support resolution of reimbursement issues (insurance changes, prior authorizations, appeals, other) according to established SOPs. - Strive to deliver an exceptional customer1 experience. - Maintain complete, timely and compliant case records for all interactions and case records in the CRM system and other systems as required - Strictly follow all relevant Ipsen Policies and SOPs - Utilize only approved resources and messages to perform function responsibilities Note: “Customer” in the context of this Job Description represents the broad and general discipline related to “customer focus and service” and not a specific transactional relationship. HOW - Technical Competencies Required - Exceptional proficiency to overcome access-related issues at the provider and payer level. - Strong understanding of and comfort with a highly regulated life-sciences environment - Functional competencies include: Market, Disease and Product Knowledge, Customer Understanding - especially Patient, Customer Experience, Operations and Customer Engagement - Demonstrated ability to listen, solve problems, seek answers and drive to solutions - Ability to navigate difficult conversations and handle sensitive matters - Excellent written and verbal communication skills - Comfort and aptitude for using information technologies - Proven track record for consistently meeting or exceeding quantitative and qualitative goals HOW - Knowledge & Experience Knowledge & Experience: - Minimum 5 years of recent case management experience in the healthcare or Pharma/Biotech industry, reimbursement experience related to specialty products, and/or Experience working with patient access, benefits investigations, billing and coding, and social service support - Exceptional proficiency to overcome access-related issues at the provider and payer level. - Rare-disease experience a plus - Demonstrated passion for patients - Reimbursement experience and strong understanding of health insurance and benefits, co-pay assistance programs, Medicare, Medicaid, and private-payer policies - Strong understanding of and comfort with a highly regulated life-sciences environment Education / Certifications (essential): - Bachelor’s degree in health care, social work, nursing or equivalent degree Language(s) (essential): - English The annual base salary range for this position is $91,500 - $134,200. This job is eligible to participate in our short-term incentives program. At Ipsen we are proud to offer a comprehensive employee benefits package, including 401(k) with company contributions, group medical, dental and vision coverage, life and disability insurance, short- and long-term disability insurance, as well as flexible spending accounts. Ipsen also provides parental leave, paid time off, a discretionary winter shutdown, well-being allowance, commuter benefits, and much more. The pay range displayed above is the range of base pay compensation within which Ipsen expects to pay for this role at the time of this posting. Individual compensation within this range depends on a variety of factors, including, but not limited to, prior education and experience, job-related knowledge and demonstrated skills We are committed to creating a workplace where everyone feels heard, valued, and supported; where we embrace “The Real Us”. The value we place on different perspectives and experiences drives our commitment to inclusion and equal opportunities. When we include diverse ways of thinking, we make more thoughtful decisions and discover more innovative solutions. Together we strive to better understand the communities we serve. This means we also want to help you perform at your best when applying for a role with us. If you require any adjustments or support during the application process, please let the recruitment team know. This information will be handled with care and will not affect the outcome of your application. Ipsen is an equal opportunity employer that strictly prohibits unlawful discrimination. We recruit, employ, train, compensate, and promote without regard to an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.

Title: Senior Clinical Development Director Company: Ipsen Biopharmaceuticals Inc. About Ipsen: Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Supported by nearly 100 years of development experience, with global hubs in the U.S., France and the U.K, we tackle areas of high unmet medical need through research and innovation. Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries. We build a workplace that champions human-centric leadership and fosters a culture of collaboration, excellence and impact. At Ipsen, every individual is empowered to be their true selves, grow and thrive alongside the company’s success. Join us on our journey towards sustainable growth, creating real impact on patients and society! For more information, visit us at https://www.ipsen.com/ and follow our latest news on LinkedIn and Instagram. Job Description: JOB DESCRIPTION Position Job Title: Director, Clinical Development, Rare Diseases Therapeutic Area Division / Function: Rare Diseases Therapeutic Area (RDTA), Global R&D Manager (Name, Job Title): Sr Director, Odevixibat Clinical Development Lead Location: This is a remote role; however, if local to an R&D hub (Cambridge, MA; London, UK; Paris, FR), the candidate will have the option to come into the office as desired Summary / purpose of the position We are looking for a Director, Clinical Development in the Rare Diseases Therapeutic Area to join our Clinical Development team. The Medical Development Director will provide medical guidance and leadership in the design, implementation, monitoring and interpretation of our clinical development programs in rare liver diseases. Main responsibilities / job expectations Main Responsibilities Main Tasks Core Remit of Activities Internal to Therapeutic Area Development (approx. 75%) - Provide medical expertise and leadership in the design and implementation of clinical development strategies aligned with company objectives. - Lead the development of clinical trial protocols, ensuring scientific rigor and compliance with global regulatory requirements. - Provide study leadership and collaborate with cross-functional team members across the lifecycle of the study (i.e., design, execution, interpretation, and communication). - Serve as medical monitor for clinical trials and to ensure adherence to ICH GCP, patient safety, and data integrity, in close collaboration with the CRO medical monitor. - Provide medical expertise for interactions with regulatory authorities, including required regulatory documentation and responses to questions from global regulatory agencies. - Build and maintain strong relationships with clinical investigators and thought leaders. - Effectively fosters productive and collegial working relationships in a cross-functional, matrix environment with internal and external stakeholders. Knowledge, abilities & experience - Advanced scientific degree (MD [or equivalent], PhD or PharmD). - 5+ years of clinical research and/or drug development experience within the pharmaceutical industry, a CRO, or similar organization. - Experience in designing and conducting Phase I-III clinical trials and providing medical expertise for regulatory submissions such as IND/CTA/NDA/MAA. - Pediatric hepatology expertise preferred. Key Technical Competencies Required - Objective-driven, solution and results oriented, with a solid sense of urgency. - Ability to thrive in a fast-paced and dynamic environment. - Excellent verbal, written, and interpersonal communication skills. - Ability to lead teams with diverse backgrounds to deliver results. - Demonstrated ability to work cooperatively within and outside the organization to accomplish the best outcomes for Ipsen. The annual base salary range for this position is $255,000 - $306,000. This job is eligible to participate in our short-term incentives program. At Ipsen we are proud to offer a comprehensive employee benefits package, including 401(k) with company contributions, group medical, dental and vision coverage, life and disability insurance, short- and long-term disability insurance, as well as flexible spending accounts. Ipsen also provides parental leave, paid time off, a discretionary winter shutdown, well-being allowance, commuter benefits, and much more. The pay range displayed above is the range of base pay compensation within which Ipsen expects to pay for this role at the time of this posting. Individual compensation within this range depends on a variety of factors, including, but not limited to, prior education and experience, job-related knowledge and demonstrated skills. We are committed to creating a workplace where everyone feels heard, valued, and supported; where we embrace “The Real Us”. The value we place on different perspectives and experiences drives our commitment to inclusion and equal opportunities. When we include diverse ways of thinking, we make more thoughtful decisions and discover more innovative solutions. Together we strive to better understand the communities we serve. This means we also want to help you perform at your best when applying for a role with us. If you require any adjustments or support during the application process, please let the recruitment team know. This information will be handled with care and will not affect the outcome of your application. Ipsen is an equal opportunity employer that strictly prohibits unlawful discrimination. We recruit, employ, train, compensate, and promote without regard to an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.

• Conducting and managing audit activities with applicable regulatory requirements and company policies • Lead and deliver a combination of risk-based GDP/GCP/GVP/GCLP audits across internal and external partners • Own audit planning, execution, reporting and CAPA oversight • Act as a trusted subject matter expert, advising stakeholders and supporting regulatory inspections • Coach and peer-review auditors, contributing to continuous improvement of Ipsen’s audit framework • Collaborate globally within the Global Quality Audit team

Title: Global Brand Lead, Migraine Location: Cambridge One Main Full time Job Description: About Ipsen: Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Supported by nearly 100 years of development experience, with global hubs in the U.S., France and the U.K, we tackle areas of high unmet medical need through research and innovation. Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries. We build a workplace that champions human-centric leadership and fosters a culture of collaboration, excellence and impact. At Ipsen, every individual is empowered to be their true selves, grow and thrive alongside the company’s success. Join us on our journey towards sustainable growth, creating real impact on patients and society! Job Description: The Global Brand Lead, Migraine is responsible for defining and driving the global commercial strategy for Ipsen’s migraine franchise. The role's primary accountability is for the launch preparation of Dysport in chronic and episodic migraine and early brand strategy for IPN10200, Ipsen’s next-generation neuromodulator currently in Phase II development. This role will establish migraine as a major new growth pillar for Ipsen, positioning Dysport to redefine the standard of care in episodic migraine and accelerate Ipsen’s expansion in the US and globally. Working in close partnership with the Global Asset Lead, the Global Brand Lead serves as the global commercial architect of the migraine franchise, ensuring that development, evidence generation, market access, and commercialization strategies collectively support a differentiated value proposition versus leading migraine competitors. The role requires understanding of the US migraine market, which represents the largest and most competitive market globally and the primary launch engine for the franchise. The leader will translate deep customer insights and competitive intelligence into global brand strategies that are scalable across priority markets including the US, EU5, and international regions. Benchmarking against best-in-class migraine launches, the Global Brand Lead will build a high-impact launch platform capable of shaping treatment paradigms, driving guideline adoption, and establishing Ipsen as a long-term leader in migraine care. The position combines strategic leadership, launch excellence, and franchise building, with the ultimate goal of creating a sustainable, multi-asset migraine franchise delivering significant global revenue growth and meaningful patient impact. WHAT - Main Responsibilities & Technical Competencies Global Migraine Franchise Strategy - Define and lead the global migraine franchise strategy, ensuring clear differentiation and long-term value creation for Dysport migraine and IPN10200. - Shape the commercial vision for chronic and episodic migraine, identifying opportunities to redefine treatment paradigms and establish Ipsen as a leader in neuromodulator-based migraine therapy. - Develop the Integrated Global Brand Plan aligned with the Integrated Asset Strategy led by the Therapeutic Lead. - Drive long-term franchise planning, including lifecycle management, indication sequencing, and portfolio expansion opportunities. Dysport Migraine – Global Launch Leadership - Lead global launch preparation for Dysport in migraine, ensuring a differentiated positioning versus established therapies and emerging competitors. - Define target patient segments, value proposition, and positioning strategy grounded in clinical differentiation and real-world value. - Develop global launch playbooks, messaging frameworks, and commercialization models scalable across priority markets. - Partner with regions and affiliates to ensure US-led launch excellence and global adaptation. - Drive launch readiness frameworks, KPIs, and performance dashboards to ensure execution excellence. IPN10200 – Early Global Brand Strategy - Support the early commercial strategy for IPN10200, ensuring development decisions are informed by customer insights, market dynamics, and future value positioning. - Translate competitive insights into future brand differentiation and clinical value narratives. - Influence key development decisions including: - Target product profile - Trial design and endpoints - Patient population prioritization - Competitive positioning. US Market Leadership & Competitive Positioning - Bring deep expertise in the US migraine ecosystem, including neurologists, headache specialists, integrated delivery networks, and payer environments. - Ensure the US market drives global strategy, while enabling adaptation for other regions. - Monitor and anticipate competitive moves - Shape strategies to ensure Ipsen competes effectively against market leaders. External Engagement & Market Shaping - Build strong relationships with global migraine KOLs, headache societies, and advocacy groups. - Contribute to shaping the future treatment paradigm and clinical narrative in migraine. - Lead brand presence at major scientific congresses (AHS, EHF, AAN). Performance & Franchise Growth - Define and track global migraine franchise KPIs. - Continuously optimize strategy based on real-world insights, market feedback, and competitive dynamics. HOW - Knowledge & Experience - 15+ years of experience in the pharmaceutical or biotech industry. - Proven experience leading major product launches, particularly in the US market, including DTC campaigns - Strong expertise in migraine, neuroscience, or other large specialty markets with a consumer centric focus. - Demonstrated ability to build global brands with significant growth potential. - Good understanding of US healthcare ecosystem including payers, IDNs, and specialty care pathways. - Track record of leading cross-functional teams in complex global organizations. - Several years of experience leading marketing and/or brand teams (including direct reports) - Experience in migraine launches or franchises (e.g., CGRP inhibitors, Gepants, neuromodulators) is an advantage - Experience competing in highly competitive, mass-prevalence disease areas. - Experience working across US, EU, and international markets. - Able to work from our Cambridge, MA HQ on a flexible hybrid model - Able to travel domestically and internationally Education / Certifications - BA/BS in Business, Economics, Life Sciences or related discipline is required - MBA or equivalent business qualification is preferred Language(s) (essential): - English (fluent – spoken and written) Language(s) (preferred): - Additional languages e.g., French or other a benefit The annual base salary range for this position is $232,500 to $341,000 This job is eligible to participate in our short-term incentives program. At Ipsen we are proud to offer a comprehensive employee benefits package, including 401(k) with company contributions, group medical, dental and vision coverage, life and disability insurance, short- and long-term disability insurance, as well as flexible spending accounts. Ipsen also provides parental leave, paid time off, a discretionary winter shutdown, well-being allowance, commuter benefits, and much more. The pay range displayed above is the range of base pay compensation within which Ipsen expects to pay for this role at the time of this posting. Individual compensation within this range depends on a variety of factors, including, but not limited to, prior education and experience, job-related knowledge and demonstrated skills. #LI-HYBRID We are committed to creating a workplace where everyone feels heard, valued, and supported; where we embrace “The Real Us”. The value we place on different perspectives and experiences drives our commitment to inclusion and equal opportunities. When we include diverse ways of thinking, we make more thoughtful decisions and discover more innovative solutions. Together we strive to better understand the communities we serve. This means we also want to help you perform at your best when applying for a role with us. If you require any adjustments or support during the application process, please let the recruitment team know. This information will be handled with care and will not affect the outcome of your application. Ipsen is an equal opportunity employer that strictly prohibits unlawful discrimination. We recruit, employ, train, compensate, and promote without regard to an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.

Title: Corporate Account Director, Southwest Company: Ipsen Biopharmaceuticals Inc. About Ipsen: Ipsen is a mid-sized global biopharmaceutical company with a focus on transformative medicines in three therapeutic areas: Oncology, Rare Disease and Neuroscience. Supported by nearly 100 years of development experience, with global hubs in the U.S., France and the U.K, we tackle areas of high unmet medical need through research and innovation. Our passionate teams in more than 40 countries are focused on what matters and endeavor every day to bring medicines to patients in 88 countries. We build a workplace that champions human-centric leadership and fosters a culture of collaboration, excellence and impact. At Ipsen, every individual is empowered to be their true selves, grow and thrive alongside the company’s success. Join us on our journey towards sustainable growth, creating real impact on patients and society! For more information, visit us at https://www.ipsen.com/ and follow our latest news on LinkedIn and Instagram . Job Description: The Corporate Account Director (CAD) of the is a vital member of the Value & Access team and will lead the strategic and tactical execution of Ipsen’s portfolio in key corporate and federal accounts. They will ensure access for Ipsen products thru partnerships with key system decision makers in the Hospitals, IDN’s, Acute-Care GPO, Federal, and Internal Provider Pathway organizations. The CAD will work closely with other Value and Access team members, field sales, marketing, HEOR, medical affairs and thought leader liaisons to ensure appropriate customer access, medical education, and innovative programs are in place such that Ipsen can exceed its commercial objectives. Furthermore, the CAD will be responsible for increasing volume growth and market share within the Region’s targeted key accounts by developing, managing, and executing Ipsen’s overall portfolio strategy. This CAD role will be responsible for the Southwest region which includes UT, CO, AZ, NM, TX, OK and LA . Main Responsibilities Portfolio Quarterback : Coordinate Ipsen resources at key target accounts to ensure all clinical, economic, access, educational support, and patient services information is made available to provider organizations for a comprehensive review of our medications Accounts: Focus access strategies for cross-functional account teams with various organizations such as Integrated Delivery Networks (IDNs), hospital systems, Acute Care Group Purchasing Organizations (eg, Vizient, Premier or HealthTrust), Federal accounts (eg, National VA PBM, National DHA (DoD) Pharmacy Operations Division, Veteran Integrated Service Networks (VISNs), Key VA and DHA (DoD) institutions, Indian Health) and Internal Provider Pathways (eg. Phillips Pathway) Customers: Establish and manage relationships with Pharmacy, C-Suite, D-Suite, Heads of Departments and Key Decision Makers (KDMs) in population Health to facilitate access. Work with representatives and leadership in each key target account on opportunities related to pull through of pharmacy initiatives based on preferred pricing, FDA indications and overall value of Ipsen's therapeutic agents Access: Ensure Ipsen products have parity or preferred coverage within accounts Strategy: Assist and collaborate with brand teams, V&A Verticals, Commercial Leadership in the development of brand strategies and business plans through market insights, data trends, customer protocols and processes, B2B and Top to Top meetings with Executive leadership at accounts and with Ipsen Leaders to ensure a consistent company message for the portfolio. Plan, initiate, negotiate, and manage profitable business relationships with assigned accounts. Portfolio: Maintain dialogue with KDMs to raise profile of Ipsen as a strong presence in oncology, neuroscience, hematology, and rare diseases Lead Execution: Create and lead pull-through strategies with field force to increase volume growth, market share and profitability through account specific business plans and execution with collaborative partners. Lead cross functional account teams regionally and nationally to ensure all Ipsen resources and support are applied appropriately to meet access objectives for the account. Cross Functional Excellence: Establish and maintain strong communication, collaboration, and coordination with all internal cross functional Ipsen teams. Resources: Develop, negotiate, and execute contracts with key accounts to maximize profitable access for Ipsen in both non-340B, 340B and safety net hospitals. Appropriately engage with HEOR to raise awareness of Ipsen’s products with effectively communicating Ipsen’s Real World Evidence to population TL’s throughout an organization. Create, analyze, and present Budget Impact Model analysis that includes financial savings, performance, and trends. Business Plans: Develop and present business plans for geography to senior leadership to ensure alignment with overall product strategy. Educate: Educate field teams and cross collaborative partners on opportunities within the Institutions, Acute Care GPOs, Federal, Provider Pathway segments on process, protocol, decision makers, market dynamics, trends, strategy, account management and business acumen. Knowledge & Experience At least 10 years of relevant sales experience within biopharma Minimum 2-5 years of Account Management experience including institutional experience Proven track record of consistently meeting or exceeding quantitative and qualitative targets Experience working with customers and accounts within the Northeast region Strong presentation and organizational skills, setting and executing against deadlines and delivering on commitments Experience with both Pharmacy and Medical benefit products, with strong knowledge of Oncology, Neuroscience and Rare Disease (emphasis on Oncology) Excellent communication and cross-functional collaboration skills Knowledge of business and the marketplace to advance the organization’s goals Operating effectively even when things are not certain, or the way forward is not clear to effectively solve problems Building partnerships and working collaboratively with others to meet shared objectives Planning and prioritizing work to meet commitments aligned with organizational goals to achieve results Holding self and others accountable to meet commitments Education BA/BS is required MBA or other advanced degree preferred The annual base salary range for this position is $165,750 - $243,100 This job is eligible to participate in our short-term incentives program. At Ipsen we are proud to offer a comprehensive employee benefits package, including 401(k) with company contributions, group medical, dental and vision coverage, life and disability insurance, short- and long-term disability insurance, as well as flexible spending accounts. Ipsen also provides parental leave, paid time off, a discretionary winter shutdown, well-being allowance, commuter benefits, and much more. The pay range displayed above is the range of base pay compensation within which Ipsen expects to pay for this role at the time of this posting. Individual compensation within this range depends on a variety of factors, including, but not limited to, prior education and experience, job-related knowledge and demonstrated skills. We are committed to creating a workplace where everyone feels heard, valued, and supported; where we embrace “The Real Us”. The value we place on different perspectives and experiences drives our commitment to inclusion and equal opportunities. When we include diverse ways of thinking, we make more thoughtful decisions and discover more innovative solutions. Together we strive to better understand the communities we serve. This means we also want to help you perform at your best when applying for a role with us. If you require any adjustments or support during the application process, please let the recruitment team know. This information will be handled with care and will not affect the outcome of your application. Ipsen is an equal opportunity employer that strictly prohibits unlawful discrimination. We recruit, employ, train, compensate, and promote without regard to an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.

• Manage the preparation of a complex suite of regulatory documents e.g. protocols, CSRs, briefing documents, meeting requests, investigator brochures, clinical modules. • Lead Writing/Editing complex Clinical Dossiers/Safety Reports. • Review documents to ensure compliance with documentation quality standards, regulatory requirements and consistency of messages across all documents for a product within a clinical dossier. • Plan and create timelines to produce assigned documents. • Ensure proper planning and resourcing of all documents assigned to Writing/Editing Team. • Actively contribute to best practices and continuous improvement within the therapeutic Area. • Represent the group in functional and cross functional initiatives/projects when required. • Network and share best practices to ensure efficiency and consistency across product teams. • Demonstrate a thorough understanding of timelines, budgetary constraints and scopes of work. • Adhere to the quality control process and ensure all work produced has gone through the correct internal review process. • Maintain a working knowledge of pharmaceutical industry standards and compliance. • Stay informed of upcoming projects, assist management in projecting resources, and perform administrative duties as requested. • Identify and participate in the qualification of Medical Writing consultants and vendors, and oversee their writing activities to ensure timely and quality deliverables are completed within budget.

• Provide medical expertise and leadership in the design and implementation of clinical development strategies aligned with company objectives. • Lead the development of clinical trial protocols, ensuring scientific rigor and compliance with global regulatory requirements. • Provide study leadership and collaborate with cross-functional team members across the lifecycle of the study (i.e., design, execution, interpretation, and communication). • Serve as medical monitor for clinical trials and to ensure adherence to ICH GCP, patient safety, and data integrity, in close collaboration with the CRO medical monitor. • Provide medical expertise for interactions with regulatory authorities, including required regulatory documentation and responses to questions from global regulatory agencies. • Build and maintain strong relationships with clinical investigators and thought leaders. • Effectively fosters productive and collegial working relationships in a cross-functional, matrix environment with internal and external stakeholders.