The Role
The Compliance Director develops and implements compliance programs, partners with departments to enhance compliance culture, and conducts training on laws and regulations.
Summary Generated by Built In
Who We Are
Cogent Biosciences is a publicly traded biotechnology company focused on developing precision therapies for genetically defined diseases. The most advanced clinical program, bezuclastinib, is a selective tyrosine kinase inhibitor that is designed to potently inhibit the KIT D816V mutation as well as other mutations in KIT exon 17. KIT D816V is responsible for driving systemic mastocytosis (SM), a serious disease caused by unchecked proliferation of mast cells. 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. Top-line results from registration-directed trials in NonAdvanced SM, Advanced SM and GIST are expected in 2025. The company also has an ongoing Phase 1 study of its novel internally discovered FGFR2 inhibitor. In addition, the Cogent Research Team is developing a portfolio of novel targeted therapies to help patients fighting serious, genetically driven diseases targeting mutations in ErbB2, PI3Kα and KRAS.
Our Team
https://cogent.culturehq.com
We’re seeking an energetic, versatile, and highly driven compliance professional to join our growing Legal & Compliance team as Compliance Director. The successful candidate will help develop all aspects of our corporate ethics and compliance program and partner closely with all departments including commercial, medical, market access, and R&D to ensure the successful and compliant launch of our late-stage therapeutic candidate. Reporting to the Senior Corporate Counsel, Commercial Healthcare and Compliance, the Compliance Director will work with all levels of employees, including senior management. The role requires superb project management and operational skills, sound judgment, a team mentality, and flexibility to support our compliant and ethical business in this highly regulated space, with meaningful opportunities for professional development and career growth.
Responsibilitties
- Contribute to the development and implementation of Cogent’s ethics and compliance program, including by developing policies and trainings, supporting monitoring efforts, and working to implement key vendors.
- Partner across all departments to promote and enhance a culture of compliance, identify and mitigate compliance risks, and guide compliant business practices.
- Conduct compliance training for commercial and other teams to ensure understanding of key policies, laws, best practices, regulatory requirements and ethical standards.
- Support development of key processes and programs, such as transparency reporting, compliance monitoring, and training documentation systems.
- Develop and maintain knowledge of key laws, regulations, and industry guidance, including the Anti-Kickback Statute, False Claims Act, Federal Sunshine Act, and various state laws and industry guidance (e.g., PhRMA Code)
- Develop and conduct training and periodic updates for internal teams on relevant topics and legal developments.
Qualifications
- BA/BS degree required; J.D. or other advanced degree a plus.
- 10+ years’ experience in compliance departments in the biopharmaceutical industry, in both operational and business partnering roles. Broad experience in an emerging, publicly traded biopharmaceutical company environment is a plus.
- Experience in creating and enhancing right-sized compliance programs. Prior experience implementing a corporate compliance program for a biopharmaceutical company through its initial commercial launch is highly preferred.
- Business partnering skills: demonstrated ability to partner effectively with growing and evolving commercial and other teams to achieve business goals while mitigating compliance risks; think strategically and analytically to solve issues in a pragmatic and efficient manner; and communicate those solutions clearly and concisely.
- Ability to manage multiple tasks timelines in a fast-paced environment with attention to quality and detail.
- Strong interpersonal skills, including proven ability to interact and communicate effectively with individuals from multiple departments at all levels of the organization, including senior leadership.
- Commitment to professionalism and ethical conduct, including ability to handle confidential and/or sensitive information.
- Excellent verbal and written skills, allowing for an open and effective dialogue throughout the company.
- Ability to travel up to 10- 25% of the time.
- This role is hybrid (two days a week in office in Waltham, MA); local candidates are strongly preferred.
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.
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The Company
What We Do
Cogent Biosciences is a 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 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.
