Medical Director - Waltham, MA, United States - American Society of Clinical Oncology (ASCO)

Description

The Role:

This is a unique opportunity for a highly motivated, talented and experienced physician to play a key role in designing rational precision therapies that treat the underlying cause of disease to improve patients' lives.

This position will be a key team member in the research and development organization and will be a vital part of helping to achieve the Cogent vision: to discover, develop, and commercialize best-in-class therapies that have a dramatic impact for patients with genetically defined diseases. Cogent is a place where your input matters -- you will have a direct impact on our science and will help to build our capability as a team. You will also shape the Cogent culture and be a part of a passionate, transparent, and collaborative work environment.

For the Medical Director role, we are looking for a research-focused physician with clinical expertise to partner with our research teams and provide medical and clinical scientific leadership for potential drug candidates and early development programs, focusing on rationale development of precision small molecules. Industry experience is not required for the Medical Director role; however, experience in the conduct and oversight of clinical studies in academia or industry is preferred.

Working on cross-functional multidisciplinary product teams, you will advance promising drug candidates into clinical development and drive the development strategy, the design of clinical trials, and contribute to the execution of the clinical development plan in support of the overall asset strategy. If desired, you may have the opportunity to take on primary medical monitor responsibilities, including oversight of trial subject safety and clinical data review and interpretation, potentially in collaboration with and supported by a clinical scientist, as the program advances.

Responsibilities

• Work closely with Cogent's research teams to provide medical, disease-specific, and development perspective into specific research programs or broader research initiatives as required.
• Provide medical expertise to assess the clinical relevance and therapeutic potential of early-stage drug candidates, considering their mechanism of action and potential patient populations.
• Foster strong collaborative relationships with research teams to facilitate the translation of scientific discoveries into clinical development strategies.
• Work collaboratively with all stakeholders from internal cross functional team members to external consultants, CRO partners, key opinion leaders, investigators, and various committee members to achieve efficient, cost effective, and high-quality design of the clinical development plan.
• Develop an understanding of the clinical and competitive environment and work with the asset team to develop the target product profile.
• Provide medical input into clinical trial documents including but not limited to the study protocol, informed consent form, statistical analysis plan, case report form, clinical study report
• Provide scientific, clinical development and medical input into all other program documents in support of the development plan, including but not limited to study protocols, the investigators' brochure, regulatory filings and submissions, abstracts, manuscripts and publications, clinical study reports, clinical pharmacology/translational medicine plans, etc.

Qualifications

• MD or MD/PhD from an accredited medical school
• Minimum of 3 years of clinical experience, with expertise in oncology.
• Board certification/eligibility in medical oncology is strongly preferred.
• Clinical or basic science research experience in industry or academia
• Strong understanding of targeted therapies, genetic biomarkers, and genetically defined diseases, particularly in the context of oncology.
• A working knowledge of biostatistics, translational sciences, clinical pharmacology, scientific and other technical disciplines and processes intimate with the drug development process
• Outstanding communication skills (written and verbal, both formal and informal)
• Ability to manage multiple projects and initiatives simultaneously in a fast-paced environment
• Effective skills directed toward driving collaboration, achieving results, influencing, and resolving conflicts across internal and external project teams