Team Leader, DMPK

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

This position works with a fast-paced team in Drug Discovery and Development to provide scientific direction and strategy across the DMPK department by being an expert in the design, execution and interpretation of in vitro ADME and in vivo PK experiments. The successful candidate will utilize their strong knowledge of ADME/PK to collaborate cross-functionally with in-house medicinal chemistry, pharmacology and toxicology teams and outside CROs. Critical thinking, independence and innovative problem solving are hallmarks for the position. The ideal candidate will lead, mentor, motivate and manage a small team in addition to ownership of an oncology project.

Responsibilities

• Lead and implement evolving DMPK strategies within the department, program team and work across disciplines to advance small molecule oncology therapeutics toward the clinic.
• Apply literature, cutting edge techniques and critical thinking to solve problems within DMPK with high independence.
• Design, conduct and supervise the analysis of in vitro and in vivo DMPK studies.
• Interpret bioanalytical and PK results and perform NCA PK modeling.
• Develop LC-UV-MS/MS analytical methods to quantitate compounds, metabolites and biomarkers in biological fluids.
• Manage interactions with CROs as pertains to program team objectives.
• Conduct written and verbal scientific presentations to project teams and senior management with a high level of independence.
• Prepare data and reports as needed for dose prediction, IND and other regulatory needs.
• Good written and oral communication, including timely electronic laboratory notebook entries, group presentations and meeting administration.
• Proven work ethic, competence, enthusiasm, problem solving and team focus.
• Supervisory responsibilities including leading, mentoring, motivating and managing scientist(s) within the in vivo DMPK group.

Knowledge/Skills/Abilities

• Critical thinking, problem solving, independence, cross-discipline awareness, multi-tasking in a fast-paced environment.
• Strategic thinking to implement effective tactics quickly.
• Scientific and technical knowledge around pharmacokinetics, formulation, drug metabolism, drug transporters and enzyme kinetics.
• Working in-depth knowledge of DMPK and relationships of in vitro and in vivo assays
• Strong knowledge of LC-MS/MS instrumentation, troubleshooting, method development and analysis of biological fluids and tissues, preferably on Sciex QQQ platform.
• Non-compartmental PK modeling, metabolite identification, in vitro ADME and in vivo assay development, drug formulation, project presentations, meeting supervision, and report writing.
• Human dose prediction, process automation via software or robotics is a plus.

Experience

• Minimum of 5 years of DMPK in Pharma/Biotech (PhD), 12 years for MS, 14 years for BS.
• Wide in vitro ADME exposure, in vivo PK, bioanalysis, PK modeling and project team leadership.
• Proven track record of leading project teams to identify clinical candidates.
• Demonstrated experience optimizing ADME properties to improve oral pharmacokinetics while adequately addressing risks (DDIs, hERG, etc)
• Utilization of impactful, cost-effective mechanistic assays when appropriate
• Successful leadership of other DMPK scientists with impactful outcomes and high retention.

Education

• PhD in Drug Metabolism, Pharmaceutical Sciences, Toxicology, Pharmacokinetics, Pharmacology, Biochemistry, Biology, Chemistry or other relevant field. Other non-PhD degree applicants with similar area of focus will be considered with significant years of industrial experience and demonstrated breadth of DMPK knowledge.