Senior Director, Commercialization and Development Counsel
We are partnered with a commercial stage biopharma with a robust pipeline ranging from preclinical to phase III focused on developing medicines for infectious diseases. The company utilizes technology to develop adaptive antibody therapies.
They are seeking a Senior Director, Commercial Counsel to join a collaborative legal team. This role reports to the Chief Legal Officer, offering the opportunity to provide strategic legal support across multiple functional areas, including Commercial, Clinical, Medical, and Drug Safety. The ideal candidate will bring substantial experience in drug development, commercialization, and product launch activities, gained through a combination of law firm and in-house roles within the life sciences sector.
Key Responsibilites:
- Provide legal counsel on regulatory matters throughout the product lifecycle, including development, submissions, labeling, advertising, promotion, and safety.
- Advise on healthcare laws and industry standards, including federal and state regulations related to marketing, pricing, transparency, and stakeholder engagement.
- Support clinical trial programs and development pathways with strategic legal guidance.
- Serve as the legal representative on internal committees responsible for reviewing promotional and non-promotional materials, digital initiatives, and stakeholder communications.
- Counsel Market Access teams on payer strategies, pricing compliance, distribution models, patient support programs, and health economics communications.
- Deliver training and develop resources to support compliant and effective business practices across relevant functions.
Qualifications:
- J.D. from an accredited law school
- Minimum of 7 years of relevant legal experience, including time spent in a law firm and/or in-house at a pharmaceutical or biopharma company.
- Proven expertise in advising on commercialization, regulatory strategy, and promotional review matters.
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