Associate Director / Director, Toxicology

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 Toxicology Department is looking for a motivated Associate Director/Director whowill provide scientific input, help lead project teams, plan and execute IND-enabling study packages, and contribute to regulatory writing.

Responsibilities

• Lead and innovate in a multidisciplinary team environment with primary responsibility for toxicology studies to support preclinical and clinical development of the portfolio
• Provide scientific leadership on toxicological questions
• Provide detailed knowledge of current regulatory guidance and expectations including those pertaining to IND and NDA submissions.
• Lead the preparation of regulatory communication and documents to support clinical development 
• Work with senior-level staff within and outside the company, with individuals or groups such as investigators, advisory board members, customers, vendors, visitors, and the investment community
• Possess excellent written and verbal technical communication skills and the demonstrated ability to lead, guide, and influence teams in decision making

Qualifications

• PhD in applicable scientific discipline with 10-15 years of related experience in pharmaceutical industry or MS degree with required skill set + 10-20 years of related experience in pharmaceutical industry with increasing responsibility
• DABT preferred
• Must have experience in regulatory, writing documents to support clinical development 
• Ability to work effectively in multi-disciplinary teams that include toxicologists, pharmacologists, cell biologists, chemists, and DMPK.
• Highly proficient computer skills in MS Office (Outlook, Teams, Word, Excel, PowerPoint) and Prism
• Demonstrate excellent verbal and written communication skills
• Excellent spelling, typing, grammar, and math skills are necessary to generate requested reports, documents, presentations, etc., as well as for proofing/editing/formatting these documents
• Excellent organizational skills, ability to work autonomously to complete assignments which often represent conflicting priorities and deadlines with limited supervision

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.