What are the responsibilities and job description for the Senior / Executive Medical Director position at Cogentbio?
Who We Are
Cogent Biosciences is a publicly traded biotechnology company developing real solutions to treat genetically driven diseases. With a focus on rational drug discovery and development, we are leveraging validated biology to advance precision therapies designed to address the true underlying drivers of disease and provide real hope for patients. Cogent’s lead therapeutic candidate, bezuclastinib (CGT9486), is a precision kinase inhibitor designed to selectively and potently inhibit the KIT D816V mutation. This mutation is responsible for driving a rare and serious condition called Systemic Mastocytosis (SM), which can severely impact many different tissues and organs in the body. We are also studying CGT9486 to treat advanced gastrointestinal stromal tumors (GIST), which have a strong dependence on oncogenic KIT signaling. We are currently enrolling two Phase 2 clinical trials for patients with SM and a global Phase 3 trial for GIST patients.
The Role :
This is a unique opportunity for a highly motivated and talented physician to join the team at an exciting time during the development of bezuclastinib with the anticipated readout of 3 registrational studies within 2025. You would play a key role in the development of bezuclastinib, the lead Cogent molecule, across multiple indications including systemic mastocytosis and GIST. Reporting to VP, Head of Clinical Development, you 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 organization 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.
By providing cross-functional leadership to a multidisciplinary product team, you will oversee the clinical development strategy and execution of NDA submissions. Also, as part of the cross-functional team, you will contribute to life cycle management and commercial planning activities in anticipation of launch. Management of a medical director responsible for medical monitoring activities on the clinical trials and work in collaboration with clinical scientists on clinical data review and interpretation is expected.
Responsibilities
- Oversee all aspects of clinical development activities for bezuclastinib, providing strategic and medical leadership to ensure the successful execution and reporting of ongoing clinical trials to enable a successful registration and launch.
- 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 submission.
- Provide medical input into all other documents in support of the integrated development plan.
- Provide oversight of bezuclastinib clinical program ensuring execution and completion of clinical trials in alignment with regulations, ICH / GCP guidelines, and internal SOPs.
- Assess external clinical research proposals involving bezuclastinib and manuscripts that are being prepared for publication.
- Work collaboratively with internal stakeholders (e.g., Commercial, Medical Affairs, Pharmacovigilance, Regulatory, Clinical Development Operations, and Biostatistics) and external vendors (e.g., CROs, consultants) to achieve program objectives.
- Partner with Clinical Development Operations to ensure timely and compliant completion and reporting of all clinical study activities.
- Contribute to and partner on the development of strategic initiatives and various organizational initiatives in Clinical Development.
- Foster a collaborative and high-performing team environment.
- 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.
- 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.
- Work with external partners on due diligence activities, as needed.
- Develop a deep understanding of the clinical and competitive landscape.
Qualifications
300,000 - $360,000 a year
Target Bonus : 20-25%
Our Locations
Waltham, MA : Our Boston office includes an open office layout that has recently undergone a makeover designed for collaboration and giving our employees the best work place possible. Free access is provided for both on-site parking and gym facilities in the building.
Boulder, CO : We have just moved into our new state-of-the art Research Facility in the fast-growing biopharmaceutical hub in the greater Denver / Boulder corridor. Our CEO is based full-time in this location and we are proud to call this the home of Cogent’s discovery research organization.
Our Offer To You
To attract the very best talent, we offer a generous benefits package that includes competitive pay, performance-based bonus, stock options, insurance coverage (health, dental, life, and disability), competitive time-off, a 401(k) plan, and commuter / parking benefits.
We are proud to be an Equal Opportunity Employer. Our goal is to have a diverse workforce. We do not discriminate on the basis of race, age, color, religion, national origin, gender, sexual orientation, gender identity or expression, veteran status or disability, or any other status protected under federal, state, or local law. All employment is decided on the basis of qualifications, merit, and business need.
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Salary : $300,000 - $360,000
