Job Description

Cogent is looking for a dynamic individual to lead our Clinical Pharmacology and Translational Medicine organization.  Reporting into the CMO, this individual will lead the clinical pharmacology strategy and oversee technical execution across the areas of clinical pharmacology and translational medicine.  This position 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.

WHAT YOU WILL DO

Reporting to the Chief Medical Officer, you will be focused on the following activities:

• Accountable for the clinical pharmacology strategy for Cogent Biosciences pipeline, including design and implementation of program specific clinical pharmacology studies, data analysis, internal decision points, and external regulatory interactions
• Oversee the development and implementation of a biomarker strategy for precision small molecules
• Develop and execute scientifically rigorous strategies to inform development and regulatory decisions through all phases of drug development
• Demonstrate drive, visibility and influence in key company decisions including development candidate selection, patient dosage selection, clinical strategy, and regulatory filing strategy.
• Manage and be accountable for pharmacokinetic, pharmacodynamic, drug interaction, and anti- drug antibody data for all clinical trials
• Leverage internal and external expertise and your own network to draft, plan, implement, and execute against organizational objectives
• Actively partner with Clinical Development, Clinical Operations, and CMC functions in driving asset and company strategy to fruition
• Build external consultant networks to set the right balance of internal versus external capabilities
• Contribute to driving the shape of global regulatory filings including preparation of regulatory documentation and active participation in meetings with regulatory agencies

Qualifications

WHAT YOU BRING

• PhD and/or equivalent and experience in one or preferably more of DMPK, clinical pharmacology, pharmacometrics, nonclinical toxicology and pharmaceutics disciplines with at least 10 years of relevant and current technical and leadership experience
• Experience leading and applying pharmacometric approaches such as population PK, PKPD, and disease progression models to support research and development
• Excellent quantitative skills and a vision to leverage the science of dosage projection/simulation, drug-drug interactions, drug transporters, quantitative systems pharmacology, mechanistic toxicology risk assessment, and pharmaceutics in a cutting edge discipline.
• Experience with tyrosine kinase inhibitors (TKI) strongly preferred
• Documented experience in drug development process including multiple regulatory submissions
• Outstanding interpersonal and communication skills both written and oral and ability to communicate complex information succinctly
• Excellent analytical and problem-solving skills and 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

Additional Information

OUR LOCATION

Cambridge, MA: Our Boston office is located within walking distance of the Alewife T station in Cambridge, MA. Our space 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), unlimited time-off, a 401(k) plan, and commuter/parking benefits.

• Cogent is an equal opportunity employer
• Note to agencies – we are not accepting unsolicited resumes from agencies and will not be responsible for fees associated with any such submittals