Director Senior Director Clinical Sciences

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/

The Role   This is a unique opportunity to play a key role in drug development at an early-stage, well-funded, and fast-growing biotech company.  This position will be a key participant in the research and development organization and will be a vital part of helping to achieve Cogent deliver patient cures.  Cogent is a place where your input matters -- you will have a direct impact on our science and will help to build our capability as a team. You will also shape the Cogent culture and be a part of a passionate, transparent, and collaborative work environment.   For the Director / Senior Director of Clinical Sciences, we are looking for a resourceful, entrepreneurial, and matrixed individual who excels in operating at both strategic and “roll up your sleeves” levels, both in support of specific programs as well as the entire enterprise.  The opportunity requires a creative thinker who takes independent initiative to identify and address challenges, and also works collaboratively to drive the development and refinement of clinical and scientific processes and procedures in support of program deliverables.  This individual will work with the research and development teams to support the preclinical assets moving into clinical development.  In addition, this individual will help support the development and standardization of clinical research processes and procedures. As the organization grows and matures, the successful individual will be able to assume increasing strategic and leadership responsibilities, and augment this internal expertise with broad, yet flexible, external expertise in support of a growing development portfolio. 

Responsibilities

• In cooperation with the VP of clinical development and key Cogent R&D stakeholders, contribute to the clinical strategy and creation of the clinical development plans for one or more candidate clinical drug products.
• 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 program clinical scientist(s).

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.
• 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.