Senior Medical Director
- Full-Time
- Cambridge, MA
- Cogent Biosciences
- Posted 2 years ago – Accepting applications
Job Description
Who We Are
Cogent Biosciences is a 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 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.
Our Team
https://cogent.culturehq.com/
The Role:
This is a unique opportunity for a highly motivated and talented physician to play a key role in the development of bezuclastinib, the lead Cogent molecule, across multiple indications including systemic mastocytosis and GIST. Reporting to SVP, Head of Clinical Development, the Director of Clinical Development 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.
Working on cross-functional multidisciplinary product teams, and leading clinical development subteams, you will drive the development strategy, the design of clinical trials, and take accountability for the execution of the clinical development plan in support of the overall asset strategy. Primary medical monitor responsibilities, including oversight of trial subject safety and clinical data review and interpretation is expected, potentially in collaboration with and supported by a clinical scientist. What You Will Do:
Cambridge, MA: Our Boston office includes an open office layout designed for collaboration. Free access is provided for both on-site parking and gym facilities in the building. We are in close proximity to leading academic institutions like MIT and Harvard and to potential pharmaceutical and biotech partners. This unique location allows for a high level of energy and intellectual exchange within and among fast growing early stage companies.
Boulder, CO: We are in the process of building a second location in the fast-growing biopharmaceutical hub in the greater Denver/Boulder corridor. Our CEO is based full-time in this location, which will serve as the future 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.
In an effort to protect our employees and extended communities from COVID-19, Cogent requires all employees to be fully vaccinated against COVID-19 unless they receive an approved reasonable accommodation for medical or religious reasons.
Apply to this Job
Cogent Biosciences is a 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 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.
Our Team
https://cogent.culturehq.com/
The Role:
This is a unique opportunity for a highly motivated and talented physician to play a key role in the development of bezuclastinib, the lead Cogent molecule, across multiple indications including systemic mastocytosis and GIST. Reporting to SVP, Head of Clinical Development, the Director of Clinical Development 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.
Working on cross-functional multidisciplinary product teams, and leading clinical development subteams, you will drive the development strategy, the design of clinical trials, and take accountability for the execution of the clinical development plan in support of the overall asset strategy. Primary medical monitor responsibilities, including oversight of trial subject safety and clinical data review and interpretation is expected, potentially in collaboration with and supported by a clinical scientist. What You Will Do:
- You will join the the bezuclastinib asset team as the Clinical Development Lead, and in that capacity, you will participate in all aspects of the overall asset strategy, drive the clinical development strategy, and assume accountability for the execution of that strategy
- You will lead a cross-functional clinical sub team and work with team members to develop and execute the clinical development plan
- You will work collaboratively with all stakeholders from internal cross functional team members to external consultants, CRO partners, key opinion leaders, investigators, and various committee members.
- you will 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.;
- you will provide scientific, clinical development and medical input into all other program documents in support of the development plan, including but not limited to informed consent forms (ICF), case report forms (CRF), statistical analysis plans (SAP), and clinical pharmacology/translational medicine plans etc.
- You will provide primary medical monitor responsibilities, including oversight of trial subject safety and clinical data review and interpretation
- You will develop a deep understanding of the clinical and competitive environment and work with the asset team to develop the target product profile
- MD or MD/PhD with at least 4 years of experience in drug development. Board certification/eligibility in medical oncology, hematology, or allergy/immunology is highly preferred.
- A creative problem solver with the proven ability to work independently and collaboratively in a fast-paced, result oriented environment.
- Outstanding communication skills (written and verbal, both formal and informal).
- Strong interpersonal, organization, and planning and communication skills. Effective skills directed toward driving collaboration, achieving results, influencing, and reaching consensus across internal and external stakeholders
- A working knowledge of biostatistics, data management, clinical operations, translational sciences, clinical pharmacology and other technical disciplines and processes intimate with the drug development process
- Base Salary Range $202,822 - $339,265
- Bonus Target 20-25% of Base Salary
Cambridge, MA: Our Boston office includes an open office layout designed for collaboration. Free access is provided for both on-site parking and gym facilities in the building. We are in close proximity to leading academic institutions like MIT and Harvard and to potential pharmaceutical and biotech partners. This unique location allows for a high level of energy and intellectual exchange within and among fast growing early stage companies.
Boulder, CO: We are in the process of building a second location in the fast-growing biopharmaceutical hub in the greater Denver/Boulder corridor. Our CEO is based full-time in this location, which will serve as the future 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.
In an effort to protect our employees and extended communities from COVID-19, Cogent requires all employees to be fully vaccinated against COVID-19 unless they receive an approved reasonable accommodation for medical or religious reasons.