*This position will be located on-site in Menlo Park, CA / Princeton, NJ / or Miami, FL

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 Therapeutic Area Head, Clinical Development will be primarily responsible for developing and executing an integrated strategy and clinical trial program for a specific therapeutic area in oncology. Proposed areas include but are not limited to gastrointestinal (GI) oncology, breast oncology, head and neck oncology (HNSCC), and genitourinary oncology (GU).

The incumbent will be responsible for providing clinical expertise, obtaining scientific advisory input from external experts, working cross-functionally to develop clinical studies, supporting regulatory interactions for product advancement, and partnering with the operations team to provide advice and decision making regarding medical input to achieve operational excellence. The incumbent must be a recognized expert in a therapeutic area in oncology, have demonstrated effective collaborative skills to work across various phases of clinical development, and serve as a key medical expert for multiple cross functional teams. Investigator engagement including travel to support face-to-face interaction and protocol training is a vital component of this role. Prior experience in a mid-sized, fast-growing pharmaceutical environment is preferred, as this role will be working on product development in a fast-paced and intense environment.

The Therapeutic Area Head will serve as a leader on one or more potentially pivotal programs reporting directly into the Chief Medical Officer.

Role and Responsibilities:

• Significant oncology experience: the role will require expertise in the treatment and management of oncology disease such that knowledge can be applied to the strategy and clinical development of Summit medicines to benefit patients
• Established network and relationships with oncology experts, investigators and opinion leaders
• Work cross functionally with Medical Affairs, Regulatory, Commercial and other functions to develop the overall product strategy in multiple indications
• Work cross functionally with Clinical Operations, Biometrics, Pharmacovigilance, and other functions to successfully complete clinical development programs leading to BLA approvals
• Lead teams to execute on clinical development goals (clinical trial execution, clinical development strategy, medical affairs planning)
• Manage direct reports or cross functional team members as needed based on team needs
• Contribute to the communication strategy of Summit products via publications, manuscripts, abstracts, posters and scientific presentations
• Make vital contributions and leading 1-2 pivotal programs in clinical development program.
• Direct human clinical trials, phases 1-3, for lead candidate in development, helping to ensure all clinical development milestones are met including enrollment goals
• Participate in medical review of adverse event reports and monitoring of incoming safety data in conjunction with product safety/pharmacovigilance, including evaluating and escalating safety signals
• Coordinate and develop information for reports submitted to FDA, EMA, PMDA, and government, regulatory, or partner agencies
• Present to various external stakeholders - regulators, governing and harmonization bodies, principal investigators, scientific conference attendees, advisors and opinion leaders.
• Maintain knowledge of clinical trial conduct to support operational needs for planning and executing clinical trials, including adherence to protocols, safety reviews, assay development, training, and clinical document review
• Plan, reviewing and editing Clinical Study Reports
• Plan, reviewing and editing publications from the program
• Provide input on the design of clinical studies supporting clinical strategy
• All other duties as assigned

Experience, Education and Specialized Knowledge and Skills:

• Board certified or eligible MD with hematology/oncology product development and experience across stages of clinical development
• 10+ years' experience in pharmaceutical industry or biotech R&D environment
• Experience in academic or research environment involving the collection and analysis of human data in the area of hematology/oncology preferred
• Working knowledge of clinical development pathways for hematology/oncology therapeutics in the US and EMEA
• Self-starter who will move forward with key initiatives without being prompted, able to perform a myriad of tasks needed to support the clinical development program, possesses a highly entrepreneurial and growth mindset, works collaboratively with cross-functional teams, loves a good mission
• Ability to lead a dynamic team and work in a fast-paced, hands-on and changing environment
• Clear and provable evidence of effective leadership skills

The pay range for this role is $344,000-$430,000 annually. 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.