Vice President, Legal Affairs
Vice President, Legal Affairs
Posted on :
15-08-2025
Employer Active
1 Vacancy
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Monthly Salary
$ 375000 - 400000
Vacancy
1 Vacancy
Posted on :
15-08-2025
Job Description
Rezolute is a late-stage rare disease company focused on significantly improving outcomes for individuals with hypoglycemia caused by hyperinsulinism (HI). Our antibody therapy RZ358 (ersodetug) is designed to treat all forms of HI and has shown substantial benefit in clinical trials and real-world use for the treatment of congenital hyperinsulinism (cHI) and tumor hyperinsulinism (tHI).
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 companys principal legal officer advising executive leadership and working cross functionally to ensure all legal issues are addressed
- Develop and lead the companys 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.
Rezolute (RZLT) currently anticipates the base salary for theVice President Legal Affairs role could range from$375000 to $400000and will depend in part on the successful candidates geographical location and their qualifications for the role including education and experience. This position will also be eligible for an annual performance bonus in accordance with the terms of the applicable plan (depending in part on company and individual performance and at the Companys discretion on an individual basis). The compensation described above is subject to change and could be higher or lower than the range described based on current market survey data and the qualifications education experience and geographical location of the selected candidate. Rezolute offers competitive compensation stock options and a rich benefits package.
Qualifying employees are eligible to participate in benefit programs such as:
- Health Insurance (Medical / Dental / Vision)
- Disability Life & Long-Term Care Insurance
- Holiday Pay
- Tracking Free Vacation Program
- 401(k) Plan Match
- Educational Assistance Benefit
- Fitness Center Reimbursement
We are an Equal Opportunity Employer and do not discriminate against applicants due to race ethnicity gender veteran status or on the basis of disability or any other federal state or local protected class.
Required Experience:
Chief
Employment Type
Full-Time
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