Associate Director, Translational Medicine

Who We Are:

Cogent Biosciences is a publicly traded biotechnology company focused on developing novel precision therapies to treat a broad range of patients with unmet medical needs. Cogent’s lead program, bezuclastinib, is designed to selectively and potently inhibit exon 17 mutations found within the KIT receptor tyrosine kinase, including KIT D816V. KIT D816V is responsible for driving a rare and serious condition called Systemic Mastocytosis, and exon 17 mutations are also found in patients with gastrointestinal stromal tumors (GIST), a type of cancer with strong dependence on oncogenic KIT signaling. Bezuclastinib has exhibited promising initial data across all three trials: APEX in AdvSM, SUMMIT in NonAdvSM and PEAK in GIST, including an encouraging safety profile across 600+ patients in single agent and combination dosing.

The Role:

The Associate Director, Translational Medicine plays a critical role in both Clinical Development and in support of nonclinical Research at Cogent. Reporting to Senior Director, Translational Medicine, you will play a critical role in representing the Translational Medicine function and provide subject matter expertise on cross-functional project teams

In partnership with Discovery Research and Clinical Development teams, you will lead the implementation of biomarker strategies to accelerate program transition from discovery research to clinical development. You will support decision making on patient selection/stratification, and utilizing biomarkers to predict drug efficacy and/or assess biological activity in humans and lead scientific and technical management implementation of clinical trial biomarker strategy.

Responsibilities:

• Contribute to design of biomarker and/or diagnostic strategies for clinical programs
• Identify and utilize appropriate biomarkers to predict drug efficacy and/or assess biological activity in humans
• Oversee the use of biomarkers in clinical studies, writing protocols for incorporation of biomarkers in clinical trials, training trial sites or clinical CROs to ensure protocols are followed, and contribution to regulatory documents
• Analyze, interpret and report results of clinical biomarker analyses, including support of regulatory filings, congress presentations and publications.
• Direct the development, outsourcing and validation of clinically applicable biomarker assays
• Function as key point of contact with biomarker vendors
• In partnership with Research team, contribute to the identification of biomarkers, generation, and analysis of biomarker data to support assessment of target engagement, pathway modulation and disease modification to understand mechanism of action
• Collaborate with Research team for successful translation of nonclinical research to biomarkers suitable for implementation in clinical studies

Qualifications:

• PhD in Biology, Pharmacology, Genetics/Genomics, or other related discipline with 5+ years of relevant biopharmaceutical industry experience.
• Strong understanding of clinical development and experience in clinical biomarker study execution including vendor management, data flow, interpretation and reporting. Experience with oncology trials is a plus.
• Current knowledge of FDA, EMA, ICH, GCP/GLP and other applicable guidelines related to qualification and validation of bioanalytical and biomarker assays
• Experience in broad range of platform technologies for biomarker assays (e.g., IHC, NGS, flow cytometry, PCR, and other technologies used in tumor tissue and liquid biopsies)
• Proficiency in data analysis software such as Spotfire or R
• Excellent interpersonal, leadership, communication, and time-management skills
• Desire to work within a fast-paced, innovative, and collaborative environment