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Medical Director

• Work closely with Cogent’s clinical development and research teams to oversee early clinical development activities and provide strategic and medical leadership to support the growing research pipeline and early-stage assets at Cogent.
• Contribute to and partner on the development of strategic initiatives and various organizational initiatives in Clinical Development.
• Help develop a more structured decision-making process for which programs advance into phase 1 and subsequently beyond clinical proof of concept.
• Participate in the strategic prioritization of programs in the pipeline.
• Play an active role in the technical and leadership development of Clinical Development team members via management of Medical Director(s) and mentoring of team members.
• Contribute to the growth of the early development organization at Cogent through development of strategies, templates, and processes to advance early-stage assets.
• Participate in due diligence activities and partnership discussions when appropriate.
• Provide medical, disease-specific, and development perspective for 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.
• Review and lead the interpretation of clinical trial data and collaborate on the preparation of clinical study reports, presentations, and publications for scientific conferences and peer-reviewed journals.
• Oversee the writing of all critical program documents including but not limited to study protocols, the investigators’ brochure, regulatory filings and submissions, abstracts, manuscripts and publications, clinical study reports, etc.
• Collaborate with the regulatory team to develop briefing documents and other regulatory documents in support of IND submissions.
• Provide medical input into all other documents in support of the clinical development plan.
• Provide oversight of early development clinical programs ensuring execution and completion of clinical trials in alignment with regulations, ICH/GCP guidelines, and internal SOPs.
• Provide and/or oversee primary medical monitor responsibilities, including oversight of trial subject safety and clinical data review and interpretation.
• Foster a collaborative and high-performing team environment.
• Represent the company at scientific and regulatory meetings, conferences, and advisory boards.
• Work with external partners, including CROs, academic institutions, and key opinion leaders (KOLs), to ensure successful execution of clinical trials and delivery of the integrated clinical development strategy.
• Develop a deep understanding of the clinical and competitive landscape and work with the asset team to develop the target product profile.

Executive Medical Director