Associate Director, Translational Medicine
Cogentbiosciences
Waltham
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
Salary Range:
$190,000 to $230,000 USD
Waltham, MA: Our headquarters is located in the Greater Boston life sciencescommunity, with an open, collaborative office environment designedto support teamwork and connection. Employees benefit from convenient on-site amenities, including free on-site parking and gym facilities in the building.
Boulder, CO: Our Boulder location is home to Cogent’s discovery research organization and a key scientific hub with strong leadership based on site. Situated in the greater Denver-Boulder biopharmaceutical corridor, this office plays a central role in advancing our discovery efforts and pipeline.
Our Offer To You
At Cogent Biosciences, we offer a competitive salary, bonus, and ongoing stock awards, alongside a benefits package that sets us apart.We cover 100% of medical, dental, and vision premiums for you and your family, and help reduce out-of-pocket costs by funding up to 75% of in-network deductibles. Our benefits also include a 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, and company-paid short-term disability coverage for up to 20 weeks.Additionalperks likewellness programs, tuition reimbursement, and inclusive family-forming support help you thrive at work and beyond.
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.
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