Description:

How will your role help us transform hope into reality?
The Senior Director, Healthcare Law is responsible for partnering on a broad range of legal matters for A Precision Therapy Company' products and product candidates, including reviewing promotional, medical, and other external communication and educational materials, and providing strategic advice across the commercial, medical and clinical organization. You will leverage your understanding of A Precision Therapy Company' business, biopharmaceutical companies, and the legal and regulatory framework relevant to our industry to provide thoughtful, solution-oriented legal advice that furthers the company's business strategy and protects the company's interests. Reporting to the Senior Vice President, Healthcare Law & Privacy, you will partner with teams in the U.S. and Europe. This position offers the opportunity to work in a dynamic environment where initiative, creative thinking and teamwork are valued!

What Will You Do?

Serve as legal reviewer on promotional and medical review teams and partner with Commercial, Medical Affairs, and Regulatory Affairs to help ensure compliance, consistency, and accuracy in connection with promotional, medical, and disease awareness materials, publications, scientific and medical meeting materials, training materials, and materials for advisory boards, speaker programs, patient programs and the like.
Provide strategic advice to Commercial and Medical Affairs on structuring new programs and initiatives in compliance with applicable laws, regulations, and industry standards.
Provide legal support and guidance to Clinical Development and Clinical Operations.
Work collaboratively as a member of cross-functional teams to review other external and internal communication materials including press releases, conference call scripts, corporate presentations, social media postings, website content, and webinar materials.
Plan and actively participate in field-team leadership and other field-team meetings in collaboration with Compliance colleagues.
Assist with developing and conducting trainings or other educational materials for internal teams.
Support Legal & Compliance department's initiatives as requested and represent the department on cross-functional teams, company-wide initiatives or committees, and special projects, as assigned.
Maintain a working knowledge of applicable laws, regulations, enforcement actions, and policy issues to identify emerging trends and risks.
Keep department colleagues, senior management, and cross-functional partners informed of trends and risks and help implement related policies, procedures, and training programs.
This position may require periodic domestic and international travel and does not have managerial responsibility or budgetary discretion.

What minimum qualifications do we require?

J.D. from an accredited law school
Member in good standing of the Massachusetts bar
12+ years of legal experience with the biopharmaceutical industry in a large law firm or an in-house legal department, with at least 5 years of experience in-house

What additional qualifications will make you a stronger candidate?

Expertise providing thoughtful and pragmatic strategic advice to Commercial, Medical and Clinical teams, as well as advising on advertising and promotional matters as a member of an in-house legal department at a commercial-stage biopharmaceutical company.
Prior experience advising businesses with therapeutics for rare diseases is strongly preferred.
A thorough understanding of healthcare laws and regulations related to development and commercialization of biopharmaceutical products, including without limitation US Federal healthcare program requirements under the Food, Drug and Cosmetic Act, the False Claims Act, the Anti-Kickback Statute, Office of Inspector General advisory opinions and letters, and the Foreign Corrupt Practices Act.
Sound judgment, high integrity, and commitment to ethical conduct
Excellent analytical, written, and verbal communication skills
Excellent professionalism and interpersonal skills
Ability to work collaboratively as a member of cross-functional teams with a pragmatic approach and a positive attitude in a results-driven, highly accountable environment
Ability to lead and think beyond “legal” and to lead cross-functional innovative initiatives
Ability to communicate with colleagues at all levels of the organization with both the self-confidence necessary to set forth opinions even in the face of contrary views and the humility needed to be receptive to the ideas and opinions of others
Demonstrated ability to think strategically and pay close attention to detail
Strong project management skills and ability to handle multiple responsibilities simultaneously and still meet high quality and timeliness standards
Self-motivated and independent team member who constantly seeks, designs, and implements improvements
Commitment to our Core Values: Patients First, Thoughtfulness, Urgency, Trust, Optimism