Senior Associate Counsel, Commercial and Regulatory
4 weeks ago
Our company culture is rooted in trust, inclusion, our capacity to collaborate, and our commitment to being honest and brave in our desire to successfully transform the lives of people with cancer.
Primary Responsibility
The Senior Associate Counsel, Commercial and Regulatory will be an integral part of Adaptimmune’s cell therapy business and its mission to provide cell therapies to cancer patients. Focusing on the commercial, sales, and regulatory areas within Adaptimmune, the individual will support the Company's product portfolio and launch activities related to product candidates, including promotional support and legal support for regulatory compliance.
Provision of legal services will include:
- In coordination with the commercial strategy team, serving as day-to-day lead and strategic legal business partner to the commercial, medical and regulatory affairs teams, as well as patient advocacy/support teams, in connection with the Company’s efforts to commercialize products
- Providing comprehensive and high-quality legal support in the areas of sales, marketing, promotional/medical/patient materials, patient access/support/reimbursement, government contracts and pricing, managed care, fraud & abuse, and regulatory and legal compliance with federal and state statutes, FCPA, rules and regulations, privacy, safety/product liability law, and other laws, regulations and Company policies and procedures
- Drafting and negotiating pharma-related commercial and medical affairs contracts (e.g. supply, manufacturing, distribution, managed markets, vendor) and/or other agreements;
- Providing legal advice to ensure compliance with legal requirements, including staying up-to-date with such requirements to proactively advise the Company;
- Interfacing with other members of the legal team, members of management and business as necessary.
Key Responsibilities
Provision of legal assistance and advice to business
- Drafting and negotiating a broad range of agreements, including agreements focused on supply, manufacturing, distribution, payers, government contracts and pricing agreements, managed markets, and vendors
- Drafting template agreements under direction from Deputy GC and/or GC
- Responsibility for management of own matters with supervision/assistance from Deputy GC and/or GC where necessary
- Interfacing with management and employees as necessary, both in the UK and US to ensure progression of matters within required timescales
- Having a broad outreach across wider organization, e.g., commercial, regulatory, med affairs
- Liaising with external counsel as appropriate, upon direction from Deputy GC and/or GC
- Leading cross-functional programs (e.g., across commercial, regulatory, med affairs) for legal.
- Collaborating with commercial launch stakeholders on all aspects of product positioning, branding, marketing, promotion, patient education and advocacy, etc.
- Providing legal guidance for sales, marketing, promotional/medical/patient materials, patient access/support/reimbursement, government contracts and pricing, managed care, etc. in view of regulations and Company policies and procedures
- Specify internal governance policies, draft policies and enforce compliance where necessary, working with corporate compliance team (going forward)
- Responsibility for training employees on policies and legal requirements together with other members of legal team
- Identification of areas where additional policies or compliance are required or could benefit the business
Required
- 4-8 years legal experience including at least 3 years at a commercial-stage pharmaceutical or biotechnology company involved with product launches;
- JD degree from an accredited law school; licensed in good standing with Pennsylvania state bar preferred;
- Broad knowledge of and significant legal experience in anti-kickback, Sunshine Act reporting, FDCA, OIG, privacy, FCPA and other statutes, regulations, guidances, enforcement, and trends applicable to the development, marketing and sale of pharmaceutical products, especially the US environment;
- Experience reviewing advertising, copy and promotional materials, advising on reimbursement and patient support activities, and reviewing product labels;
- Experience drafting and negotiating pharma-related commercial and medical affairs contracts (e.g. supply, manufacturing, distribution, managed markets, vendor) and/or other agreements. Experience with government price reporting preferred;
- Proven ability to manage competing priorities (and opinions) across cross-functional teams, and demonstrated multinational matrix project team leadership;
- Accountability for decision making and confidence to challenge colleagues; and
- Proven ability to think strategically about achieving corporate objectives by addressing the needs of internal and external stakeholders, and to analyze issues and propose options and recommendations.
- Business-minded legal focus (i.e., business savvy) is strongly preferred;
- Science background preferred;
- Experience within biotech or pharmaceutical industry strongly preferred, particularly in cell and gene therapy, or ability/interest to learn applicable process technology to provide necessary legal support; and
- Experience in working within a global business desirable.
other requirements
- May require occasional travel to US offices (Philadelphia, Pennsylvania and/or Boston, Massachusetts) and UK office (Oxford, UK) (no more than twice per year)
At Adaptimmune we embrace diversity and equality of opportunity. We believe that the more inclusive we are, the better our work will be. We welcome applications to join our team from all qualified candidates, regardless of age, colour, disability, marital status, national origin, race, religion, gender, sexual orientation, gender identity, veteran status or other legally protected category. It is our intent that all qualified applicants will receive equal consideration for employment.
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