Therapeutic Area Head, Clinical Development

Job Title : Therapeutic Area Head, Clinical DevelopmentDepartment : Clinical Data ManagementLocation : Miami / Remote

Overview of Role :

Please ensure you read the below overview and requirements for this employment opportunity completely.

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 :

The pay range for this role is $400,000 – $435,000 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.

J-18808-Ljbffr

Salary : $400,000 - $435,000