Associate Director Director Clinical Science

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 Associate Director / Director of Clinical Sciences, we are looking for a resourceful, entrepreneurial, and matrixed individual who excels in operating at study team level to assist in day-to-day execution of the program in support of aa Phase 3 pivotal study slated for NDA submission.  The opportunity requires a creative thinker who takes independent initiative to identify and address challenges, and also works cross-functionally to drive the development and refinement of clinical and scientific processes and procedures in support of program deliverables.  This individual will help support the development and standardization of clinical research processes and procedures. As the organization grows and matures, this individual will be able to assume increasing strategic and leadership responsibilities, and augment their trial expertise with more broad, yet flexible, external communications in support of a growing development portfolio. 

\n

Responsibilities

• In cooperation with the Clinical Science Asset Lead and key Cogent R&D stakeholders, contribute to the clinical strategy for bezuclastinib.
• Provide scientific input to the efficacy and safety endpoint objectives of the Peak clinical trial.
• Provide clinical oversight of study execution in collaboration with cross-functional members of the clinical study team and ensure alignment with overall clinical strategy in collaboration with Clinical Science Lead for the program
• 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.
• Work closely with the Clinical Science Lead for the program to 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.
• Support and develop data outputs for various presentations including peer-review publications.
• Understand and communicate the disease and treatment landscape 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 and/or mentor program clinical scientist(s)

Qualifications

• A dynamic individual who is able to act as the subject matter expert (SME) for the cross-functional study team and contribute to the development strategy as a member of a broader 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 working on study teams representing their technical expertise while working collaboratively with colleagues to achieve milestones and goals
• Ability to work independently while navigating leadership demands by directing the broader study team in partnership with clinical operations.
• Demonstrates ability to communicate cross-functionally and write clearly, concisely, and effectively.
• 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).
• 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.
• Understands trial design and clinical trial statistics in order to apply knowledge to the design of clinical protocols
• Ability to interpret, analyze, and present clinical data to leadership 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.

\n\n

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.

Please mention the word **GLAMOROUS** and tag RMjYwMDoxOTAwOjIwMDA6ZWE6OjE6MTUwMQ== when applying to show you read the job post completely (#RMjYwMDoxOTAwOjIwMDA6ZWE6OjE6MTUwMQ==). This is a beta feature to avoid spam applicants. Companies can search these words to find applicants that read this and see they're human.