Director / Senior Director, Clinical Sciences

Who We AreCogent Biosciences is a publicly traded biotechnology company focused on developing precision therapies for genetically defined diseases. The most advanced clinical program, bezuclastinib, is a selective tyrosine kinase inhibitor that is designed to potently inhibit the KIT D816V mutation as well as other mutations in KIT exon 17. KIT D816V is responsible for driving systemic mastocytosis (SM), a serious disease caused by unchecked proliferation of mast cells. Exon 17 mutations are also found in patients with advanced gastrointestinal stromal tumors (GIST), a type of cancer with strong dependence on oncogenic KIT signaling. Top-line results from registration-directed trials in NonAdvanced SM, Advanced SM and GIST are expected in 2025. The company also has an ongoing Phase 1 study of its novel internally discovered FGFR2 inhibitor. In addition, the Cogent Research Team is developing a portfolio of novel targeted therapies to help patients fighting serious, genetically driven diseases targeting mutations in ErbB2, PI3Kα and KRAS.
Our Teamhttps://cogent.culturehq.com

Responsibilities

• In collaboration with the Executive Medical Director in   Clinical Development and key Cogent R&D stakeholders, contribute to the clinical development and regulatory submissions for bezuclastinib.
• Oversee all aspects of clinical science activities for bezuclastinib to ensure the successful execution and reporting of ongoing clinical trials to enable a successful registration and launch.
• Provide scientific input to the efficacy and safety endpoint objectives of a trial and assure efficient and innovative clinical study designs, collaborating closely with team members to assure feasibility of the clinical study.
• Provide clinical oversight of study execution in collaboration with all members of the clinical study team, in partnership with clinical operations. 
• Support the development of program documents, including clinical protocols and the clinical sections of various regulatory documents such as clinical study reports, investigator brochures, annual reports and updates, and clinical sections of regulatory submissions to support product submissions and approvals.
• Collaborate with the clinical development team on the review, analysis, and interpretation of study results and assure appropriate data review and accurate data reporting.
• Identify study issues and program issues by reviewing and monitoring of emerging clinical data related to safety and efficacy. 
• Develop sound, strategic solutions to issues and collaborate with the clinical team to ensure issue resolution.
• Prepare data for various presentations including peer-review publications.
• Maintain current knowledge of the external environment to ensure scientific innovations are considered and/or incorporated into clinical trial development strategy.
• Contribute to the development and standardization of templates, processes, infrastructure and procedures to support the clinical research needs of a growing organization.
• Oversee, manage and mentor a team of clinical scientists.
• Foster a collaborative and high-performing team environment.

Qualifications

• A dynamic individual who likes to lead and contribute as part of a passionate, growing team.
• RN, MS, PhD or PharmD, or equivalent with clinical research experience.  Advanced degree and/or professional certification/credentials highly preferred. 
• 5+ years of direct experience in clinical trial design, execution, and reporting, preferably in the pharmaceutical industry; oncology experience preferred.
• Experience managing direct reports and within a matrixed team environment.
• Thorough understanding of the drug development process from IND/CTA through BLA/NDA submission.
• Broad understanding of functional areas of drug development, including preclinical, regulatory, pharmacovigilance, drug supply, data sciences (data management, biostatistics, programming), and clinical operations (including site selection, study start-up, study conduct, and finalization).
• Demonstrated ability to communicate and write clearly, concisely, and effectively.
• Ability to understand, interpret and communicate clinical information including literature reviews, competitive intelligence, and changing treatment paradigms in order to apply knowledge to support a robust clinical development strategy.
• Understanding of trial design and statistics in order to apply knowledge to the design of clinical protocols.
• Ability to interpret, analyze, and present clinical data in order to inform decision-making and set clinical strategy.
• Well-organized: ability to prioritize tasks with a successful track record of managing multiple projects in a fast-paced and deadline-driven environment.
• Impeccable attention to detail.

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.