Senior Manager/Associate Director, Regulatory CMC
Remote
Development – Regulatory /
Full-Time /
Remote
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
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
$150,000 - $200,000 a year
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.
