Associate Medical Director

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 andour commitmentto 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 has multiple global Phase 3 clinical studies including:

Non-small Cell Lung Cancer (NSCLC)

• HARMONi: Phase 3 clinical study which was intended to evaluateivonescimabcombined with chemotherapy compared to placebo plus chemotherapy in patients with EGFR-mutated locallyadvancedor metastatic non-squamous NSCLC who were previously treated with a 3rd generation EGFR TKI.

• HARMONi-3: Phase 3 clinical study which is intended to evaluateivonescimabcombined 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 evaluateivonescimabmonotherapy compared to pembrolizumab monotherapy in patients with first-line metastatic NSCLC.

Colorectal Cancer (CRC)

• HARMONi-GI3: Phase 3 clinical study intended to evaluateivonescimabin combination with chemotherapy compared with bevacizumab plus chemotherapy.

Ivonescimabis 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 hasadditionaloffices in California New Jersey the UK and Ireland.

Overview of Role:

The Associate Medical Director will help oversee global clinical trials and BLA (Biologic Licensing Application) filings. The incumbent will be primarily responsible for developing and executing integrated clinical trial programs including protocol design and medical oversight of new or ongoing studies. They will be responsible for obtaining scientific advisory input work with biostatisticians for 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 will serve as a key medical expert for multiple cross functional teams. This position will provide medical insight across a myriad of functions from discovery to manufacturing. Additionally the Associate Medical Director will play a pivotal role in leading investigator engagements including travel to support face-to-face interaction and protocol training. The Associate Medical Director will serve as a leader on one or multiple potentially pivotal programs.

Role and Responsibilities:

• The role will require knowledge 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.
• 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)
• Contribute to the communication strategy of Summit products via publications manuscripts abstracts posters and scientific presentations
• Making vital contributions on pivotal programs in clinical development program
• 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 EMA PMDA and government regulatory or partner agencies
• Presentations to various external stakeholders - regulators governing and harmonization bodies principal investigators 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 or equivalent medical degree.
• Board certified or eligible preferred.
• Oncology experience is preferred.
• Experience in pharmaceutical biologics or biotech R&D environment or clinical experience/practice or in a research environment involving the collection and analysis of human data strongly preferred
• 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 $174000-$204000annually. 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 may be different in other locations due to differences in the cost of total compensation package for this position may also include bonus stockbenefitsand/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/agenciesare required tocontact Summits Talent Acquisition team atto obtain prior written authorization before referring any candidates to Summit.