Senior Counsel, Commercial and Healthcare Compliance
Cogent Biosciences
Legal
Waltham, MA, USA
Posted on Nov 16, 2024
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
We’re seeking an energetic, versatile and highly driven attorney to join our growing legal team as Commercial and Healthcare Compliance Counsel. The successful candidate will be a business partner and provide legal advice to the Commercial, Medical Affairs, Patient Advocacy and Regulatory teams, and will have experience providing advice on compliance with healthcare and regulatory law, including the Food, Drug, and Cosmetic Act, as well with commercial agreements regarding research and development, manufacturing, quality, sales, and marketing of pharmaceuticals. Prior experience assisting with commercial launch is essential. Reporting to the Chief Legal Officer, this position will work with multiple functional areas and assist on a broad range of legal matters across the organization.
Responsibilities
- Provide legal advice on all aspects of preparations for potential commercial launch.
- Provide legal advice to the Commercial, Medical Affairs, Patient Advocacy and Regulatory teams, ensuring that all programs, materials, and strategies are compliant with Company policies and applicable laws and regulations.
- Provide legal guidance to identify, clarify and inform compliance-based decisions and activities.
- Own the legal review of materials submitted to the MLR Committee, providing legal advice and compliance guidance on all materials.
- Work collaboratively across the organization to develop, update and implement compliance policies that are reflective of applicable laws, regulations and guidance, and conduct training for relevant employees on such policies.
- Advise business colleagues on interactions with key partners, including patients, healthcare providers, payors, governmental authorities and specialty pharmacies and monitor compliance for such interactions.
- Support commercial business legal needs, including negotiating, drafting and reviewing commercial contracts such as agreements for patient hub services, product purchase, speakers, market access and vendor agreements.
- Maintain awareness of legislation, pharmaceutical, regulatory and policy initiatives in order to counsel business leaders on potential legal risks in a way that continues to advance corporate strategy while protecting corporate assets, integrity and reputation.
- Proactively identify potential legal risks, and formulate and communicate practical solutions that meet corporate strategic objectives and priorities.
Qualifications
- J.D. from an accredited law school and a member in good standing of a state bar.
- Minimum 8+ years of legal experience in the biotechnology/pharmaceutical industry, including experience with an in-house legal department (law firm experience is a plus).
- Prior commercial launch experience is essential; experience advising a company through its initial commercial launch is preferred.
- Broad experience in an emerging, publicly traded company environment is a plus.
- A firm understanding of healthcare and compliance laws and regulations.
- Demonstrated ability to think strategically and analytically to solve legal issues in a pragmatic and efficient manner, with the ability to communicate those solutions clearly and concisely.
- 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.
- Demonstrated ability to handle multiple responsibilities simultaneously and perform at a high caliber in a fast-paced environment.
- Excellent verbal and written skills, allowing for an open and effective dialogue throughout the company.
- Attention to detail and quality are critical to success.
- Results-oriented individual who is highly motivated, decisive, flexible in thought, and has the creativity to excel in and contribute to a rapidly growing company
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.