Therapeutics Area Head, Clinical Development

Role Summary

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).

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, and 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

Qualifications

• Board certified or eligible MD with hematology/oncology product development and experience across stages of clinical development
• 10+ years' experience in university, pharmaceutical industry, academic or biotech R&D environment, or in a research environment involving the collection and analysis of human data in the area of hematology/oncology
• 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

Skills

• Strategic clinical development planning
• Cross-functional collaboration
• External stakeholder engagement
• Regulatory interactions and submissions
• Medical writing and publications planning
• Clinical trial design and management (phase 1-3)
• Safety signal assessment and pharmacovigilance collaboration
• Leadership and people management

Education

• MD with specialization in hematology/oncology

Additional Requirements

• Investigator engagement including travel to support face-to-face interaction and protocol training