Associate Director, Translational Medicine

The role

The Associate Director, Translational Medicine leads biomarker strategies to transition programs from discovery research to clinical development. This person provides subject matter expertise to cross-functional project teams and supports decision making on patient selection and drug efficacy.

What you will do

• 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
• Write protocols for incorporation of biomarkers in clinical trials
• Train trial sites or clinical CROs to ensure protocols are followed
• Contribute to regulatory documents
• Analyze, interpret and report results of clinical biomarker analyses
• Support 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

Required qualifications

• PhD in Biology, Pharmacology, Genetics/Genomics, or other related discipline
• 5+ years of relevant biopharmaceutical industry experience
• Strong understanding of clinical development
• Experience in clinical biomarker study execution including vendor management, data flow, interpretation and reporting
• 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

Nice to have

• Experience with oncology trials

Benefits

• Competitive salary
• Bonus
• Ongoing stock awards
• 100% medical, dental, and vision premiums for employee and family
• Funding up to 75% of in-network deductibles
• 401(k) match with immediate vesting
• Generous paid time off
• 12 weeks of fully paid parental leave
• Paid family and medical leave for all employees regardless of location
• Company-paid short-term disability coverage for up to 20 weeks
• Wellness programs
• Tuition reimbursement

About the company

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.