Medical Director

Location:Menlo Park CA / Miami FL / Princeton NJ ONSITE

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. Summits 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.

Summits team is inspired to touch and help change lives through Summits 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 Chinas 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:

We are seeking a physician to serve as a Medical Director to oversee global Phase 3 clinical trials andBLA (Biologic Licensing Application) filings. The incumbent will be primarily responsible for developing and executingintegratedclinical trial programs including protocol design and medical oversight of new or ongoing will be responsible for obtaining scientific advisory input work with biostatisticians for phase 3 design and analyses support regulatory interactions for product advancement and work closely with clinical operations to provide advice and decision making regarding medical input to achieve operational excellence.

The candidate must have demonstrated effective collaborative skills to work across various phases of clinical development and serve as a key medical expert for multiple cross functional position will provide medical insight across a myriad of functions from discovery to manufacturing are the Medical Director willplay a pivotal role inleadinginvestigator engagementsincluding travel to support face-to-face interaction and protocol experience in a mid-sized fast-growing pharmaceutical environment is preferred as this role will be working on product development in an extremely fast-paced and intense Medical Director will serve as a leader on oneormultiplepotentially pivotalprograms.

Role and Responsibilities:

• The role will require expertise in the treatment and management ofoncologydiseasesuch that knowledge can be applied to the strategy and clinical development of Summit medicines to benefit patients.
• 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 toexecute onclinical 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
• Making vital contributions on pivotal programs in clinical developmentprogram
• Directing human clinical trials phases 1-3 for lead candidate in development helping to ensure all clinical development milestones are met including enrollment goals
• Participating 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 EMAPMDAandgovernment regulatory or partner agencies
• Presentations to various external stakeholders - regulators governing and harmonization bodiesprincipalinvestigators scientific conference attendees advisors and opinion leaders
• 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
• Planning reviewing and editing Clinical Study Reports
• Planning reviewing and editing publications from the program
• Providing input on the design of clinical studies supporting clinical strategy
• All other duties as assigned

Experience Education and Specialized Knowledge and Skills:

• MD with hematology/oncology product development and experience across stages of clinical development
• Board certified or eligible MD preferred.
• Significant oncology experience is required
• Minimum of3 years experience in pharmaceutical biologics or biotech R&D environment or in a research environment involving the collection and analysis of human datain the area ofhematology/oncology
• Working knowledge of clinical development pathways for hematology/oncology therapeutics in the US and EMA
• 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

The pay range for this role is $237000-$250000 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 Summits Talent Acquisition team atto obtain prior written authorization before referring any candidates to Summit.