Executive Medical Director
CultureHQ
full-time
Posted on:
Location Type: Remote
Location: United States
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Salary
💰 $360,000 - $410,000 per year
Job Level
Tech Stack
About the role
- 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.
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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical developmentearly phase clinical trialsclinical researchclinical development plansregulatory submissionsbiostatisticstranslational sciencesclinical pharmacologytargeted therapiesgenetic biomarkers
Soft skills
communication skillscollaborationproject managementleadershipmentoringstrategic thinkingdecision-makinginfluencingconflict resolutionteam environment
Certifications
MD