Description:

We are seeking a strategic and hands-on Vice President of Legal Affairs to serve as the principal legal advisor for our growing biopharmaceutical company. As a member of the leadership team, this individual will be responsible for overseeing all legal matters with a focus on clinical trial agreements, commercial contracts, and corporate compliance. This is a unique opportunity to help shape the legal and compliance infrastructure of a company advancing toward its first product launch.

Key Responsibilities:

Legal Strategy & Leadership

Serve as the company's principal legal officer advising executive leadership and working cross functionally to ensure all legal issues are addressed
Develop and lead the company's legal strategy to support corporate growth, product development, and commercialization goals.
Provide proactive legal counsel on corporate governance, risk mitigation, and strategic transactions.
Collaborate cross-functionally with clinical operations, regulatory, medical affairs, commercial, compliance, and business development teams to align legal strategy with business goals.

Contract Management

Draft, review, and negotiate a broad range of clinical and commercial contracts, including
Clinical trial agreements (CTAs), informed consent forms (ICFs), CRO agreements, investigator-initiated studies (IIS), and clinical vendor agreements.
Commercial agreements including distribution, manufacturing and supply agreements, marketing and advertising contracts, patient support services agreements, and market access-related documents.
Partner with Clinical Operations, Regulatory, CMC, and Commercial teams to ensure contracts are aligned with development and launch needs.

Compliance & Regulatory Support

Build and oversee a fit-for-purpose compliance program that meets FDA, OIG, and industry guidelines (e.g., PhRMA Code).
Ensure compliance with federal and state laws related to promotional activities, privacy (HIPAA), anti-kickback statutes, and Sunshine reporting.
Provide legal guidance on regulatory and compliance issues related to clinical and commercial activities, including FDA regulations, and promotional practices.
Support internal training on compliance policies and industry best practices.

Corporate & Governance Matters

Manage legal aspects of corporate governance, including Board meetings, resolutions, and SEC/financing filings if applicable.
Provide legal support for corporate transactions, including equity financings, partnerships, and potential IPO readiness.

Risk Management & Legal Operations

Identify potential legal risks and develop mitigation strategies.
Oversee legal budgets and manage outside counsel effectively and efficiently.

Qualifications:

J.D. from an accredited law school; active bar membership in good standing.
7+ years of legal experience, with a mix of law firm and in-house biotech/pharma experience, preferably in a pre-commercial or commercial-stage environment.
Deep understanding of clinical trial contracting, biopharma regulatory frameworks, and commercial contracting.
Proven ability to build or scale legal and compliance functions in a growing organization.
Experience working with cross-functional teams in R&D, clinical operations, and commercial functions.
Exceptional judgment, problem-solving skills, and business acumen.

Preferred Qualifications:

Experience in rare disease, gene therapy, or orphan drug development.
Prior exposure to FDA regulatory matters, healthcare law, and commercial launch preparation.
Familiarity with international clinical or commercial legal issues is a plus.