Summit Therapeutics
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Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland.
9 Jobs
Corporate Counsel, Clinical Contracts
Summit TherapeuticsSummit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland.
Role Description The Corporate Counsel, Clinical Contracts is responsible for supporting the review, negotiation, and execution of company contracts across multiple departments. This position supports the Legal Department and partners with clinical, quality, medical affairs, finance, research & development, HR, IT, and other internal clients from other departments to draft and negotiate contracts that protect the company from risk, support company business objectives, and ensure compliance with company guidelines. Responsibilities - Collaborate with attorneys and other legal staff in other practice areas to proactively identify and address key legal issues for the business teams. - Draft, review, analyze and negotiate clinical related contracts, including: - Clinical trial agreements (including ancillary agreements, such as clinical study service agreements, quality agreements, and pharmacy and radiology agreements) - Investigator sponsored studies (ISTs) - Collaboration and development agreements - Sponsored research agreements - Agreements with contract research organizations (CROs) - Consulting agreements - Master services agreements and related statements of work - Promotional speaker bureau agreements - Vendor and service contracts and related work orders - IT software license agreements - HR benefit and contractor agreements - Leases - Confidentiality or non-disclosure agreements - Liaise between the internal business units and external parties, ensuring that all legal and contractual matters are addressed efficiently and promptly; escalate matters, as necessary, to reduce company risk and help ensure company business objectives are met. - Promptly respond to complex inquiries regarding contract obligations and revisions. - Identify risks and issues, propose alternatives that meet company business objectives while also reducing company risk. - Review and track in-process and ongoing agreements. - Support company employees regarding the Contract Management process. - Interact with Intellectual Property Counsel to ensure appropriate handling of intellectual property issues in agreements. - Interact with Regulatory Counsel and Compliance to ensure appropriate handling of regulatory/compliance issues in contract matters. - Interact with Quality Assurance to ensure appropriate handling of quality matters. - Prepare template agreements, modify existing templates and prepare unique agreements as required. - Ensure clear and prompt communication with company employees and outside parties regarding status of, or issues in, contracts. - Handle miscellaneous legal tasks or special assignments on an as-needed basis. - All other duties as assigned. Qualifications - Juris Doctorate from an accredited law school, and admitted to a US state bar in good standing. - Minimum of 5+ years of major law firm and/or in-house experience with a pharmaceutical, medical device, or healthcare company, with a minimum of 2+ years reviewing and negotiating Clinical Trial Agreements (U.S. and ex-U.S). - Precise drafting and strong legal analysis skills, and knowledge of the regulations and statutes and industry guidelines impacting pharmaceutical research, development and commercial contracts, including data privacy. - Proficient with Word and have a working knowledge of Excel and Microsoft Access. - Excellent written and oral communication skills; ability to work effectively and efficiently with all levels of management and personnel. - Strong organizational and planning skills and meticulous attention to detail. - Self-starter with the ability to work independently as well as collaboratively in a team environment. - Ability to handle competing priorities in a fast-paced environment and exercise sound commercial and legal judgment. - Must be flexible due to rapidly changing business environment for a growth company. Requirements - Pay Transparency: $158,000 — $185,000 USD - Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. - This may be different in other locations due to differences in the cost of labor. - The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation. Company Description Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland.
Senior Medical Science Liaison
Summit TherapeuticsSummit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland.
Role Description The Senior Medical Science Liaison (MSL) is a field-based scientific expert that strategically supports the scientific and business objectives of cancer therapeutic areas across the product life cycle. MSLs are the primary communicators of Summit Therapeutics science within a specific geography with healthcare professionals. They combine strong business acumen, clinical expertise, market awareness, and serve as a conduit of information to a cross-functional customer base internally within Summit Therapeutics. - Develop, execute and maintain high impact territory plans, including HCP and Investigator engagement plans in alignment with therapeutic area medical and scientific objectives with a focus on quality. - Support clinical development and research initiatives across development at the request of R&D to include, but not limited to, site evaluation and identification, recruitment, investigator meetings, external expert identification, and involving experts to generate scientific data including investigator-sponsored trials. - Identify, gain access to, and develop professional customer-centric based relationships with external experts in Immuno-Oncology within assigned geography. - Provide education relative to disease state, therapeutic landscape and Summit Therapeutics products across the product lifecycle to healthcare providers and researchers. - Participate, monitor, and provide insights to Summit from relevant scientific meetings in relevant geography. - Continuously maintain self-education on market issues/trends, product knowledge, and new therapeutic areas of interest as it pertains to specific business responsibilities. - Actively participate in relevant team meetings, organizational activities, and Country-driven medical affairs activities (e.g. advisory boards, masterclasses, roundtables). - Create, maintain, and collaborate in relationships with Cross-Functional partnerships, as appropriate, to develop and execute Account plans designed to support and meet shared scientific or business objectives. - All other duties as assigned. Qualifications - Doctoral degree in the health sciences from an accredited university required (MD, PhD, PharmD, or equivalent). - Significant clinical and/or industry experience in oncology and cancer therapeutic area may be accepted in lieu of education requirements. - A minimum of 5+ years of solid tumor cancer experience. - A minimum of 5+ years of clinical, scientific/research, or industry related experience or equivalent. - A minimum of 2+ years’ experience in Medical Science Liaison role. - Previous pharmaceutical industry experience within relevant scientific discipline is strongly preferred. Requirements - Understanding, analyzing and communicating complicated scientific concepts and data. - Building credible relationships with prominent HCPs. - Ability to independently identify and translate corporate needs into an action plan that will achieve objectives. - Self-motivation to achieve and exceed goals. - Problem solving and analytic skills. - Critical thinking. - Ability to work independently. - Meet health care industry representative (HCIR) credentialing requirements to gain entry into facilities and organizations in your assigned territory. - Must be willing to travel up to 75% of the time. - Proficient user of standard MS Office suite (e.g., Word, Excel), experience using electronic document management systems, and document review tools desirable. - Strong computer and database skills. - Attention to detail, accuracy and confidentiality. - Clear and concise oral and written communication skills. - Excellent organizational skills. - Must be able to effectively multi-task and manage time-sensitive and highly confidential documents. - Prioritize conflicting demands. - Work in a fast-paced, demanding and collaborative environment. Benefits - Pay Transparency: $200,000 — $240,000 USD. - Actual compensation packages are based on several factors unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. - The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation.
Senior Medical Science Liaison (OR, WA, ID, MT, WY, AK)
Summit TherapeuticsSummit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland.
About Summit: Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. At Summit, we believe in building a team of world class professionals who are passionate about this mission, and it is our people who drive this mission to reality. Summit’s core values include integrity, passion for excellence, purposeful urgency, collaboration, and our commitment to people. Our employees are truly the heart and soul of our culture, and they are invaluable in shaping our journey toward excellence. Summit’s team is inspired to touch and help change lives through Summit’s clinical studies in the field of oncology. Summit has multiple global Phase 3 clinical studies, including: Non-small Cell Lung Cancer (NSCLC) - HARMONi: Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI. - HARMONi-3: Phase 3 clinical study which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC. - HARMONi-7: Phase 3 clinical study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC. Colorectal Cancer (CRC) - HARMONi-GI3: Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy. Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland. Overview of Role: The Senior Medical Science Liaison (MSL) is a field based scientific expert that strategically supports the scientific and business objectives of cancer therapeutic areas across the product life cycle. MSLs are the primary communicators of Summit Therapeutics science within a specific geography with healthcare professionals. MSLs are the field scientific experts on Immuno-Oncology and treatment options within this therapeutic area. They combine strong business acumen, clinical expertise, market awareness, and serve as a conduit of information to a cross functional customer base internally within Summit Therapeutics. Based on therapeutic needs and product life cycles, teams may focus on certain responsibilities, including clinical development and pipeline support. Role and Responsibilities: - Develop, execute and maintain high impact territory plans, including HCP and Investigator engagement plans in alignment with therapeutic area medical and scientific objectives with a focus on quality - Support clinical development and research initiatives across development at the request of R&D to include, but not limited to, site evaluation and identification, recruitment, investigator meetings, external expert identification, and involving experts to generate scientific data including investigator-sponsored trials - Identify, gain access to, and develop professional customer centric based relationships with external experts in Immuno-Oncology within assigned geography - Provide education relative to disease state, therapeutic landscape and Summit Therapeutics products across the product lifecycle to healthcare providers and researchers - Participate, monitor, and provide insights to Summit from relevant scientific meetings in relevant geography - Continuously maintain self-education on market issues/trends, product knowledge, and new therapeutic areas of interest as it pertains to specific business responsibilities, including creating awareness and relationships for Summit Therapeutics in the Medical community - Actively participate in relevant team meetings, organizational activities, and Country-driven medical affairs activities (e.g. advisory boards, masterclasses, roundtables) - Create, maintain, and collaborate in relationships with Cross-Functional partnerships, as appropriate, to develop and execute Account plans designed to support and meet shared scientific or business objectives - All other duties as assigned Experience, Education and Specialized Knowledge and Skills: - Doctoral degree in the health sciences from an accredited university required (MD, PhD, PharmD, or equivalent). Significant clinical and/or industry experience in oncology and cancer therapeutic area may be accepted in lieu of education requirements. - A minimum of 5+ years of solid tumor cancer experience - A minimum of 5+ years of clinical, scientific/research, or industry related experience or equivalent - A minimum of 2+ years’ experience in Medical Science Liaison role - Previous pharmaceutical industry experience within relevant scientific discipline is strongly preferred - The MSL must possess and be able to demonstrate past achievements in: - Understanding, analyzing and communicating complicated scientific concepts and data - Building credible relationships with prominent HCPs - Ability to independently identify and translate corporate needs into an action plan that will achieve objectives - Self-motivation to achieve and exceed goals - Problem solving and analytic skills - Critical thinking - Ability to work independently - An essential requirement of the position is to meet health care industry representative (HCIR) credentialing requirements to gain entry into facilities and organizations that in your assigned territory. These HCIR credentialing requirements may include, but are not limited to, background checks, drug screens, and proof of immunization/vaccination for various diseases. - Other requirements: - Must be willing to travel up to 75% of the time - Proficient user of standard MS Office suite (e.g., Word, Excel), experience using electronic document management systems, and document review tools desirable - Strong computer and database skills - Attention to detail, accuracy and confidentiality - Clear and concise oral and written communication skills - Excellent organizational skills - Must be able to effectively multi-task and manage time-sensitive and highly confidential documents - Prioritize conflicting demands - Work in a fast-paced, demanding and collaborative environment This is the pay for this position Pay Transparency $200,000—$240,000 USD Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation. Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summit’s Talent Acquisition team at recruiting@smmttx.com to obtain prior written authorization before referring any candidates to Summit. Summit Therapeutics Inc. is an Equal Opportunity Employer and takes pride in creating and maintaining diverse environment. We do not discriminate in recruitment, hiring, training or promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
Senior Medical Science Liaison
Summit TherapeuticsSummit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland.
Role Description The Senior Medical Science Liaison (MSL) is a field-based scientific expert that strategically supports the scientific and business objectives of cancer therapeutic areas across the product life cycle. MSLs are the primary communicators of Summit Therapeutics science within a specific geography with healthcare professionals. They combine strong business acumen, clinical expertise, market awareness, and serve as a conduit of information to a cross-functional customer base internally within Summit Therapeutics. - Develop, execute and maintain high impact territory plans, including HCP and Investigator engagement plans in alignment with therapeutic area medical and scientific objectives with a focus on quality. - Support clinical development and research initiatives across development at the request of R&D to include, but not limited to, site evaluation and identification, recruitment, investigator meetings, external expert identification, and involving experts to generate scientific data including investigator-sponsored trials. - Identify, gain access to, and develop professional customer centric based relationships with external experts in Immuno-Oncology within assigned geography. - Provide education relative to disease state, therapeutic landscape and Summit Therapeutics products across the product lifecycle to healthcare providers and researchers. - Participate, monitor, and provide insights to Summit from relevant scientific meetings in relevant geography. - Continuously maintain self-education on market issues/trends, product knowledge, and new therapeutic areas of interest as it pertains to specific business responsibilities. - Actively participate in relevant team meetings, organizational activities, and Country-driven medical affairs activities (e.g. advisory boards, masterclasses, roundtables). - Create, maintain, and collaborate in relationships with Cross-Functional partnerships, as appropriate, to develop and execute Account plans designed to support and meet shared scientific or business objectives. - All other duties as assigned. Qualifications - Doctoral degree in the health sciences from an accredited university required (MD, PhD, PharmD, or equivalent). - Significant clinical and/or industry experience in oncology and cancer therapeutic area may be accepted in lieu of education requirements. - A minimum of 5+ years of solid tumor cancer experience. - A minimum of 5+ years of clinical, scientific/research, or industry related experience or equivalent. - A minimum of 2+ years’ experience in Medical Science Liaison role. - Previous pharmaceutical industry experience within relevant scientific discipline is strongly preferred. Requirements - Understanding, analyzing and communicating complicated scientific concepts and data. - Building credible relationships with prominent HCPs. - Ability to independently identify and translate corporate needs into an action plan that will achieve objectives. - Self-motivation to achieve and exceed goals. - Problem solving and analytic skills. - Critical thinking. - Ability to work independently. - Meet health care industry representative (HCIR) credentialing requirements to gain entry into facilities and organizations in your assigned territory. - Must be willing to travel up to 75% of the time. - Proficient user of standard MS Office suite (e.g., Word, Excel), experience using electronic document management systems, and document review tools desirable. - Strong computer and database skills. - Attention to detail, accuracy and confidentiality. - Clear and concise oral and written communication skills. - Excellent organizational skills. - Must be able to effectively multi-task and manage time-sensitive and highly confidential documents. - Prioritize conflicting demands. - Work in a fast-paced, demanding and collaborative environment. Benefits - Pay Transparency: $200,000 — $240,000 USD. - Actual compensation packages are based on several factors unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. - The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation.
Corporate Account Director, GPO
Summit TherapeuticsSummit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland.
About Summit: Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. At Summit, we believe in building a team of world class professionals who are passionate about this mission, and it is our people who drive this mission to reality. Summit’s core values include integrity, passion for excellence, purposeful urgency, collaboration, and our commitment to people. Our employees are truly the heart and soul of our culture, and they are invaluable in shaping our journey toward excellence. Summit’s team is inspired to touch and help change lives through Summit’s clinical studies in the field of oncology. Summit has multiple global Phase 3 clinical studies, including: Non-small Cell Lung Cancer (NSCLC) - HARMONi: Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI. - HARMONi-3: Phase 3 clinical study which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC. - HARMONi-7: Phase 3 clinical study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC. Colorectal Cancer (CRC) - HARMONi-GI3: Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy. Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland. Overview of Role: Reporting directly to the Executive Director, GPO & Strategic Accounts, the Corporate Account Director, GPO is responsible for establishing and maintaining strategic relationships that secure optimal market access for Summit Therapeutics’ innovative oncology medicines across Group Purchasing Organizations (GPOs), key community oncology stakeholders, and provider-driven clinical pathways. The Corporate Account Director, GPO will develop and execute strategic account plans designed to support rapid product adoption through clinical pathway and treatment protocol inclusion, while representing Summit Therapeutics with key executive decision-makers across major oncology networks and aggregators. This role also coordinates cross-functional collaboration across Commercial, Medical Affairs, Legal, Marketing and Market Access to ensure alignment and successful integration of Summit’s therapies within provider-driven pathways. Role and Responsibilities: - Translate national brand and access strategies into actionable engagement plans with GPOs, community oncology networks, and large oncology aggregators. - Lead account strategy and execution focused on accelerating clinical pathway and treatment protocol inclusion post-launch in close partnership with Medical Affairs. - Establish and maintain business-to-business and C-suite relationships with key accounts to support educational programs, market access initiatives, and strategic partnerships. - Build and sustain strong relationships with key opinion leaders, GPO executives, and leadership within large community oncology organizations. - Lead cross-functional collaboration across Commercial Field teams to proactively identify and resolve access or reimbursement barriers. - Track and analyze business opportunities and market dynamics to provide strategic and tactical insights that inform access and commercial strategy. - Negotiate favorable contracts and agreements aligned with enterprise objectives and market access strategy. - Champion the voice of the customer internally by sharing insights with brand teams, field leadership, and market access stakeholders. - Manage relationships and identify opportunities with select and targeted access stakeholders, ie. Ontada, US Oncology, AON, OneOncology. - Provide ongoing strategic feedback and insights to Commercial leadership regarding market dynamics, pathway decisions, and account priorities. - Develop medium- to long-term strategic engagement plans across accounts that support multiple product and indication launches and focus on building partnerships beyond transactional contracting. - Facilitate executive exchanges between Summit Therapeutics leadership and senior executives from GPOs and major oncology networks. - Maintain consistent, compliant engagement with GPO leadership, account managers, oncology aggregator leaders, and formulary decision-makers. - Proactively communicate emerging opportunities or risks and mobilize internal resources to address them. - Design and lead pull-through initiatives with field commercial teams to support account execution. - Conduct quarterly business reviews with key systems and internal stakeholders to monitor performance and alignment - All other duties as assigned Experience, Education and Specialized Knowledge and Skills: - Bachelor’s degree required. - 10+ years of progressive experience in strategic account management, market access, or oncology commercial roles. - Strong, established relationships with community oncology GPOs and executive leadership within large oncology clinics or networks. - Demonstrated understanding of oncology reimbursement, economic flows, and oncology market dynamics within GPO and community oncology environments. - Exceptional communication and influencing skills with the ability to engage internal leadership and external executive stakeholders. - Proven ability to clearly communicate the value proposition of innovative oncology therapies. - Strong negotiation skills with a track record of achieving outcomes aligned with enterprise and P&L objectives. - Experience supporting pipeline products and oncology product launches. - Demonstrated ability to partner effectively across Medical Affairs, Sales, Marketing, and Field Reimbursement teams. - Willingness to travel up to 50% for customer meetings, industry conferences, and internal meetings. Preferred Skills: - Advanced degree (MBA, Master’s, PharmD, or PhD). - Deep expertise and understanding of community oncology GPOs and large clinic markets. - Demonstrated success leading strategic partnerships and executive engagement initiatives beyond traditional contracting or rebate arrangements. - Oncology product launch experience, particularly within NSCLC. - Strong ability to navigate the evolving oncology market access and healthcare landscape. - Proven ability to build collaborative relationships within new or rapidly scaling commercial organizations. - Prior people leadership experience and ability to help scale teams as the organization grows. This is the pay for this position Pay Transparency $190,000—$237,000 USD Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation. Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summit’s Talent Acquisition team at recruiting@smmttx.com to obtain prior written authorization before referring any candidates to Summit. Summit Therapeutics Inc. is an Equal Opportunity Employer and takes pride in creating and maintaining diverse environment. We do not discriminate in recruitment, hiring, training or promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
Principal Statistical Analyst
Summit TherapeuticsSummit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland.
Role Description Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. At Summit, we believe in building a team of world-class professionals who are passionate about this mission, and it is our people who drive this mission to reality. Summit’s core values include: - Integrity - Passion for excellence - Purposeful urgency - Collaboration - Commitment to people Summit’s team is inspired to touch and help change lives through Summit’s clinical studies in the field of oncology. Summit has multiple global Phase 3 clinical studies, including: - Non-small Cell Lung Cancer (NSCLC) - HARMONi: Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI. - HARMONi-3: Phase 3 clinical study which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC. - HARMONi-7: Phase 3 clinical study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC. - Colorectal Cancer (CRC) - HARMONi-GI3: Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy. Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland. Pay Transparency $10 — $20 USD Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation. Equal Opportunity Employer Summit Therapeutics Inc. is an Equal Opportunity Employer and takes pride in creating and maintaining a diverse environment. We do not discriminate in recruitment, hiring, training or promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
Director, Biostatistics
Summit TherapeuticsSummit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland.
About Summit: Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. At Summit, we believe in building a team of world class professionals who are passionate about this mission, and it is our people who drive this mission to reality. Summit’s core values include integrity, passion for excellence, purposeful urgency, collaboration, and our commitment to people. Our employees are truly the heart and soul of our culture, and they are invaluable in shaping our journey toward excellence. Summit’s team is inspired to touch and help change lives through Summit’s clinical studies in the field of oncology. Summit has multiple global Phase 3 clinical studies, including: Non-small Cell Lung Cancer (NSCLC) - HARMONi: Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI. - HARMONi-3: Phase 3 clinical study which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC. - HARMONi-7: Phase 3 clinical study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC. Colorectal Cancer (CRC) - HARMONi-GI3: Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy. Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland. Overview of Role: Serves as the project level biostatistician and provides leadership within biostatistics function to develop and execute statistical strategy, study design, statistical analyses, and regulatory submissions for clinical trials in oncology. Partners with clinical science, regulatory and other team members in clinical development plans, authoring key clinical/regulatory/statistical documents, and ensuring exceptional delivery and interpretation of clinical data. Develops and implements biostatistics department policies, standards, procedures, and work-instructions in coordination with department leader and other functions. Represents biostatistics function in interactions with CROs, institutional review boards, and regulatory agencies. Role and Responsibilities: - Provide technical leadership and statistical support to clinical development through the design and conduct of clinical studies in oncology - Support/contribute to protocol development to ensure appropriateness of trial design, sample size, and propose the use of meaningful and efficient statistical methodologies - Lead development of statistical analysis plans, data presentation plans, clinical development plans, biometrics related submission activities, and post-submission strategies/responses - Review the accuracy of clinical data, perform statistical analysis, interpret study results, and collaborate with clinical team and other team members to produce interim reports, final reports, and publications - Write/review sections of meeting packages and assist in the development and review of other documents required for regulatory submissions and other regulatory processes - Review vendor data transfer specifications and ADaM programming specifications - Lead assessment and introduction of novel statistical methodologies to implement solutions - Represent biostatistics function or biometrics department in cross function teams - Work with department leader to develop and implement department policies, standards and procedures - Collaborate with clinical operations, data management and CRO to develop and implement CRFs, database design, and the overall data quality plan - Evaluate and manage CROs and other vendors, including scope-of-work, timelines, deliverables and budgets - Provide strategic statistical and regulatory guidance to anticipate challenges, mitigate risk, and ensure project success - Attend meetings with FDA or other health authorities to ensure ongoing agreement on project development - All other duties as assigned Experience, Education and Specialized Knowledge and Skills: - PhD and a minimum of 8+ years of experience or Masters (MS) and a minimum of 11+ years of experience in statistics or biostatistics or related disciplines with clinical trials, pharmaceutical/biotech industry, or healthcare experience - Experience in supporting oncology phase II/III clinical studies - Experience in organizing and driving regulatory submissions (e.g. NDA, sNDA, BLA) - In-depth knowledge of CDISC standards - Technical expertise and knowledge of experimental design and analyses using SAS, R, or EAST, and etc. - Excellent written and verbal communication skills - Good working knowledge of ICH, FDA and GCP regulations and guidelines This is the pay for this position Pay Transparency $203,000—$253,000 USD Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation. Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summit’s Talent Acquisition team at recruiting@smmttx.com to obtain prior written authorization before referring any candidates to Summit. Summit Therapeutics Inc. is an Equal Opportunity Employer and takes pride in creating and maintaining diverse environment. We do not discriminate in recruitment, hiring, training or promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
Assistant Controller
Summit TherapeuticsSummit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland.
About Summit: Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. At Summit, we believe in building a team of world class professionals who are passionate about this mission, and it is our people who drive this mission to reality. Summit’s core values include integrity, passion for excellence, purposeful urgency, collaboration, and our commitment to people. Our employees are truly the heart and soul of our culture, and they are invaluable in shaping our journey toward excellence. Summit’s team is inspired to touch and help change lives through Summit’s clinical studies in the field of oncology. Summit has multiple global Phase 3 clinical studies, including: Non-small Cell Lung Cancer (NSCLC) - HARMONi: Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI. - HARMONi-3: Phase 3 clinical study which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC. - HARMONi-7: Phase 3 clinical study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC. Colorectal Cancer (CRC) - HARMONi-GI3: Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy. Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland. LOCATION: Position can be based on-site in Palo Alto, CA / Miami, FL / Princeton, NJ or Remote if outside of commuting distance of office locations Overview of Role: The Assistant Controller will manage accounting process, lead accounting close and financial audits. Other responsibilities will apply as needs of the business change. Role and Responsibilities: - Oversee all aspects of accounting, including general ledger, cost accounting, accounts payable and payroll. - Drive the preparation and review of clinical trials and contract manufacturing related accrual and prepayment entries and reconciliations. - Perform / review various technical accounting analyses. - Maintain internal and operational controls necessary to monitor performance and comply with SOX 404, as required. - Ensure completeness and accuracy of month-end close tasks; is accountable for overseeing journal entries, balance sheet reconciliations, financial flux, key judgements, internal controls and management reporting. - Act as primary liaison with external auditors; prepare and coordinate all appropriate material for quarterly reviews and annual audits. - Collaborate with supply chain, manufacturing, and quality teams to oversee and monitor drug inventory accounting, ensuring accurate valuation, inventory reconciliation, obsolescence and excess stock inventory practices and proper compliance. - Partner with FP&A and the business to provide financial insight for budgets and forecasting. - Assist with compilation of information for preparation of tax compliance items, including but not limited to annual provisions/returns and other tax-related items and review the external tax advisors’ deliverables. - Maintain focus on continuous improvement by challenging status quo to accelerate financial accounting close and increase efficiency of accounting and reporting processes. - Support ERP implementation and upgrades as appropriate. - Develop and updated accounting policies and documentation. - Mentor and support members of the accounting team. - Other duties as assigned. Experience, Education and Specialized Knowledge and Skills - Bachelor’s or master’s in accounting; CPA preferred. - Minimum of 10+ years of progressive experience in public and private accounting. - Experience in biotech or life science industry required. - Demonstrate intellectual curiosity by interacting with business leaders to understand operational activities and ensure appropriate accounting treatment of business transactions. - Thorough knowledge of US GAAP principles. - Demonstrated ability to operate in a fast-paced environment. - Attention to detail, accuracy and confidentiality. - Excellent organizational, management, analytical & decision-making skills. - An ability to work well cross functionally and across geographies. - Impeccable integrity and a strong work ethic. This is the pay for this position Pay Transparency $215,000—$235,000 USD Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation. Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summit’s Talent Acquisition team at recruiting@smmttx.com to obtain prior written authorization before referring any candidates to Summit. Summit Therapeutics Inc. is an Equal Opportunity Employer and takes pride in creating and maintaining diverse environment. We do not discriminate in recruitment, hiring, training or promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
Director, Health Economics & Outcomes Research
Summit TherapeuticsSummit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland.
About Summit: Summit Therapeutics Inc. is a biopharmaceutical oncology company with a mission focused on improving quality of life, increasing potential duration of life, and resolving serious unmet medical needs. At Summit, we believe in building a team of world class professionals who are passionate about this mission, and it is our people who drive this mission to reality. Summit’s core values include integrity, passion for excellence, purposeful urgency, collaboration, and our commitment to people. Our employees are truly the heart and soul of our culture, and they are invaluable in shaping our journey toward excellence. Summit’s team is inspired to touch and help change lives through Summit’s clinical studies in the field of oncology. Summit has multiple global Phase 3 clinical studies, including: Non-small Cell Lung Cancer (NSCLC) - HARMONi: Phase 3 clinical study which was intended to evaluate ivonescimab combined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated, locally advanced or metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI. - HARMONi-3: Phase 3 clinical study which is intended to evaluate ivonescimab combined with chemotherapy compared to pembrolizumab combined with chemotherapy in patients with first-line metastatic NSCLC. - HARMONi-7: Phase 3 clinical study which is intended to evaluate ivonescimab monotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC. Colorectal Cancer (CRC) - HARMONi-GI3: Phase 3 clinical study intended to evaluate ivonescimab in combination with chemotherapy compared with bevacizumab plus chemotherapy. Ivonescimab is an investigational therapy not presently approved by any regulatory authority other than China’s National Medical Products Administration (NMPA). Summit is headquartered in Miami, Florida, and has additional offices in California, New Jersey, the UK, and Ireland. Overview Summit Therapeutics is seeking a Director, Health Economics & Outcomes Research, to join our mission of developing Ivonescimab, a novel and unique immunotherapy with the potential to help patients suffering from life-threatening cancers. The Director of Health Economics and Outcomes Research (HEOR) will lead initiatives to generate and communicate evidence that enhances product value and informs access strategies. This position entails developing and executing comprehensive health economics, outcomes research, and real-world evidence (RWE) plans in alignment with medical affairs strategies, clinical development objectives, and commercial approaches to support product value propositions and optimize market access. The role is responsible for disseminating scientific evidence to inform providers, payers, population-based decision makers (PBDMs), and patients about the value proposition of ivonescimab. The ideal candidate will thrive in a fast-paced environment and be adept at collaborating with internal cross-functional teams and external stakeholders. Roles and responsibilities: - Lead global and regional HEOR strategies and evidence generation projects to support market access and product value. - Collaborate with Medical Affairs and Market Access to integrate HEOR initiatives into broader strategies and stakeholder engagement plans. - Oversee the development, review, and dissemination of high-quality HEOR outputs, including protocols, analytic plans, publications, and field materials. - Provide training and develop relevant health care economic information (HCEI) materials to support field teams - Support value demonstration tactics for Health Technology Assessment (HTA), including EU Joint Clinical Assessment (JCA) and payer assessments - Maintain awareness of the quickly evolving global HTA and reimbursement landscape, help educate organization on developments within HEOR - Ensure scientific rigor and strategic alignment in all evidence generation activities. - Lead development of high-quality publications, posters, and presentations to communicate HEOR findings effectively - Develop and maintain strong alignment with the managed care liaison team to obtain insights from external stakeholders and adjust evidence generation plans accordingly - All other duties as assigned Experience/Education: - Advanced degree (Master’s, PharmD or PhD) in Health Economics, Epidemiology, Outcomes Research, Public Health or related field - Minimum 8+ years relevant experience in healthcare industry with direct experience in global value proposition development, payer, HTA, and relevant policymaker interactions and strong patient-centered focus - Direct experience in Oncology, preferably non-small cell lung cancer (NSCLC) - Expertise in US and global market access, reimbursement processes, and health technology assessment methods. - Proficiency in cost effectiveness analysis (CEA), budget impact modeling (BIM), systematic literature reviews (SLRs), indirect treatment comparisons (ITCs), statistical analyses, and real-world evidence (RWE) generation. - Strong analytical capabilities and excellent communication skills, with a track record of peer-reviewed publications - Ability to work collaboratively across diverse teams and manage multiple stakeholders, and proactively drive goals This is the pay for this position Pay Transparency $203,000—$253,000 USD Actual compensation packages are based on several factors that are unique to each candidate, including but not limited to skill set, depth of experience, certifications, and specific work location. This may be different in other locations due to differences in the cost of labor. The total compensation package for this position may also include bonus, stock, benefits and/or other applicable variable compensation. Summit does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact Summit’s Talent Acquisition team at recruiting@smmttx.com to obtain prior written authorization before referring any candidates to Summit. Summit Therapeutics Inc. is an Equal Opportunity Employer and takes pride in creating and maintaining diverse environment. We do not discriminate in recruitment, hiring, training or promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.