Senior Manager Associate Director Regulatory CMC

Who We Are

Cogent Biosciences is a 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 advanced gastrointestinal stromal tumors (GIST), a type of cancer with strong dependence on oncogenic KIT signaling. Bezuclastinib has already exhibited promising early clinical activity and safety in a Phase 1/2 trial in patients with advanced GIST and also has the potential to fill an unmet need for patients living with Systemic Mastocytosis.

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, and a 401(k) plan. 

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. 

The Role

We are seeking an independent and scientifically driven Senior Manager/Associate Director of Regulatory CMC who will be responsible for overseeing the development and implementation of global CMC regulatory strategies related to the clinical and commercial development of Cogent's products. The ideal candidate will be a collaborative contributor providing regulatory CMC leadership and strategic guidance across projects as well as provide operational leadership for regulatory CMC activities including submissions, reviews, and health authority interactions.

This critical hire will bring a strong manufacturing and analytical methodology background and experience managing multiple challenges that arise during the course of product development. Critical data review and logical problem solving are keys to a candidate’s success.

Responsibilities

·      Design, develop, and implement global regulatory CMC strategies across programs.

·      Partner with key functional counterparts and teams on the development of strategic CMC plans for Cogent's products.

·      Provide relevant guidance and advice on regulatory CMC matters to internal teams and stakeholders to assure compliance with applicable regulations.

·      Serve as a liaison for CMC with worldwide regulatory authorities.

·      Make recommendations for standard operating procedures (SOPs), best practices and procedures. May be responsible for creating and reviewing SOPs, as needed.

·      Write, review and coordinate to ensure timely submission of all regulatory CMC submission documents and responses to queries from worldwide regulatory authorities (e.g., INDs, IMPDs, NDAs, MAAs).

Qualifications

·      Direct experience with leading CMC submission preparation and CMC-focused Health Authority interactions

·      A minimum of 5+ years of relevant global Regulatory CMC experience

·      Scientific background preferred

·      Strategic thinking and strong independent problem-solving skills – No “checkbox” thinkers

·      Strong interpersonal skills and the ability to communicate effectively cross-functionally

·      Strong oral and written communication skills

·      Sound understanding of CMC and GMP related issues

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