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.
Our Team
https://cogent.culturehq.com
The Role:
The Director, Clinical Pharmacology will play an integral role in both Clinical Development and in support of nonclinical Research at Cogent. Reporting to VP of Clinical Pharmacology and Translational Medicine, this individual will represent Clinical Pharmacology function and provide subject matter expertise on cross-functional project teams. He/she will direct the clinical pharmacology development plan, synopsis preparation, clinical phase oversight, and reporting, and provide leadership of a multifunctional study team focused on clinical studies through design, delivery, and reporting, as well as ensuring scientific accountability. This role will also work intensively on domestic and international regulatory filing activities and documents.
A core scientific responsibility is ensuring the selection of optimal dose and dosing regimens in patients, and as such, the successful candidate must be able to integrate the knowledge of PK/PD, quantitative modeling and simulation, drug development, TK, and nonclinical ADME and DMPK. Working within the Clinical Development organization, the Director role supports multiple programs through participation on clinical study teams and serves as a liaison between Research and Development organizations.
Responsibilities
- Design, conduct, and manage clinical pharmacology components of clinical studies, PK and PD analysis and reporting for programs in all stages of drug development.
- Contribute to and lead the design of studies that generate PK and PD data and apply quantitative methods to integrate nonclinical and clinical PK and PD data (biomarker response, efficacy and safety) to influence go/no go decisions, support dose and dosing regimen selection, and optimize study designs throughout drug development.
- Perform PK and PK-PD modeling and non-compartmental analyses, and/or oversee and liaise with CROs for population-based PK and PK-PD analysis, draft and/or review PK reports and incorporate findings into study report and regulatory submission documents.
- Responsible for design and execution of clinical pharmacology strategy including design of clinical pharmacology studies and/or use of alternative modeling approaches.
- Contribute to the cross-functional project teams and provide sound clinical pharmacology related input and guidance to the project teams.
- Author regulatory documents (IND’s, NDA’s, IB’s etc.) and respond to regulatory inquires as well as participate directly in regulatory interactions.
Qualifications
- Ph.D. or equivalent degree in pharmacokinetics, Pharmacometrics, Pharmaceutical Sciences, or related field with minimum of 8+ years of experience in biopharmaceutical industry.
- Strong data analysis skills and an in-depth knowledge of pharmacokinetic theory, modeling and simulation methods utilizing the latest computational approaches (e.g, population PK, mechanistic PK-PD, QSP and PBPK) and analysis tools.
- Hands-on experience in non-compartmental PK analysis and inclusion of data in the preparation of internal/external presentations, study reports and sections of regulatory submission documents (eg: INDs, NDAs, CTDs).
- Hands-on modeling experience using WinNonlin, GastroPlus, SimCYP, NONMEM, Monolix and/or other modeling software is highly desired.
- Current knowledge of FDA regulatory guidance related to clinical pharmacology; recent experience having direct interaction with FDA, including submission of IND, NDA and other regulatory documents is required.
- Clinical pharmacology experience with small molecules in the area of oncology and rare diseases is desired.
- Excellent written and oral communication skills and ability to convey complex PK and PK/PD analysis methodology and outcomes to internal and external stakeholders.
- Must be comfortable and confident in presenting data to cross functional team and interacting in business and scientific discussions.
- Ability to work effectively in a dynamic, collective team environment and drive alignment among multiple stakeholders is essential.
- Direct experience in vendor management is required.
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.
