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Executive Medical Director

Full TimeRemoteTeam 1-10Since 2017H1B No SponsorCompany SiteLinkedIn

Location

United States

Posted

52 days ago

Salary

$360K - $410K / year

Postgraduate Degree5 yrs expEnglishGoogle Cloud Platform

Job Description

• 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.

Job Requirements

  • MD required, with experience in hematology / medical oncology strongly preferred
  • Significant experience in clinical development at a biotechnology or pharmaceutical company; experience at a small biotech company preferred
  • Significant knowledge and experience in the design and execution of early phase clinical trials with experience in overseeing global clinical trials from design through execution
  • Demonstrated experience in clinical research, including creating clinical development plans, and designing, planning and monitoring clinical trials, particularly Phase 1 first-in-human and proof-of-concept
  • In-depth knowledge of regulatory requirements and compliance in clinical trials
  • Experience with preparing clinical sections of regulatory submissions (e.g., INDs)
  • Experience working in a matrix team and in direct line management
  • 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.

Benefits

  • Health insurance
  • Dental insurance
  • Life insurance
  • Disability insurance
  • Paid time off
  • 401(k) plan
  • Stock options
  • Performance-based bonus

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