Overview
This role involves serving as Vice President, Associate General Counsel for the Infectious Disease Franchise at a biopharmaceutical organization focused on developing monoclonal antibodies and innovative therapies for viral infectious diseases, including COVID-19. The position provides legal counsel and business advice across multiple departments including Commercial, Clinical, Regulatory, Medical, Pharmacovigilance, Marketing, Market Access, Clinical Operations, Regulatory Affairs, Medical Affairs, Drug Safety, Patient Advocacy, Corporate Affairs, and Corporate Communications.
The role reports to the Chief Legal Officer and is part of a dynamic Legal and Compliance team. It requires significant experience in pharmaceutical or biopharma companies and/or law firms with expertise in all stages of drug development, commercialization, and product launches.
Responsibilities
- Provide strategic, operational, and tactical legal counsel related to product development and commercialization.
- Advise on FDA and global regulatory compliance throughout the product lifecycle, including regulatory submissions, advertising, promotion, and drug safety.
- Counsel on healthcare laws such as the Federal Anti-Kickback Statute, FDCA, False Claims Act, PhRMA Code, FTC regulations, HIPAA, CAN-SPAM, Sunshine Act, state price transparency laws, and product liability statutes.
- Support Clinical, Clinical Operations, Regulatory Affairs, and Pharmacovigilance teams with legal advice, business counsel, and review of materials including informed consent forms, clinical trial postings, and FDA correspondence.
- Provide legal advice, counsel, and training to Marketing on promotional strategies, advertising, digital and social media initiatives, and interactions with healthcare providers.
- Advise Market Access on payer strategies, pre-approval information exchange, distribution models, patient support programs, and HEOR communications.
- Support Medical Affairs with communications, scientific exchange, research planning, publications, presentations, and engagements.
- Review Corporate Affairs communications including social media posts.
- Collaborate with Legal and Compliance colleagues to maintain consistent legal support and assist in policy, SOP, and compliance training development.
- Participate in cross-functional teams and represent Legal on company initiatives.
- Manage outside counsel resources and budgets for complex legal matters.
- Lead or support internal and external investigations and litigation as needed.
- Potentially manage legal teams or direct reports.
Requirements
- Juris Doctor (J.D.) from an ABA-accredited law school.
- Licensed attorney in at least one U.S. state, in good standing, with ability to obtain Connecticut in-house counsel registration.
- Minimum 10 years of relevant experience in pharmaceutical/biopharma legal counsel, including combined law firm experience advising life sciences companies.
- Expertise in federal and state laws, regulations, and industry codes affecting pharmaceutical manufacturers, including drug labeling, advertising, scientific exchange, market access, government reimbursement, and product liability.
- Experience supporting regulatory and commercialization teams, including Medical, Legal, Regulatory review committees, promotional activities, market access communications, drug labeling, and scientific exchange.
- Product launch experience strongly preferred; buy and bill experience a plus.
- Knowledge of enforcement landscape including litigation, settlements, and corporate integrity agreements.
- Senior leadership and personnel management experience.
- Litigation experience is a plus.
Additional Qualifications
- Exceptional judgment, ethics, and professional maturity.
- Strong accountability, self-motivation, and interpersonal skills.
- Critical thinking and ability to analyze complex legal and business issues.
- Excellent verbal and written communication skills.
- Experience with digital and social media legal policies and compliance.
- Ability to draft, review, and interpret compliance documentation.
- Business partnership orientation with proactive problem-solving skills.
- Ability to thrive in a fast-paced, evolving environment.
- Collaborative team player with ability to work independently.
- Positive, growth mindset with interest in learning the business and science.
- Willingness to support broader legal and business initiatives.
- Strong multi-tasking and work ethic.
Location
This position is based in New Haven, Connecticut, with a hybrid work model requiring onsite presence approximately 5-10 days per month. Onsite presence is essential for collaboration and company culture. Periodic travel is required for off-site meetings, program monitoring, and conferences.
Compensation & Benefits
- Base salary range: $309,000 - $383,000 annually.
- Eligibility for annual short-term incentives (bonuses) and long-term incentives (equity).
- Compensation is based on experience, skills, and education.
Equal Opportunity
The employer is an equal opportunity organization committed to inclusive hiring practices without discrimination based on race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability, or other legally protected characteristics.
Note
Unsolicited resumes from agencies are not accepted.