Director, Legal – Clinical & Commercial Contracts
Redwood City
Legal – Legal - Contracts /
Full Time /
On-site
Location: Redwood City, California
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 an experienced, business-minded, and strategic attorney to join our rapidly growing company as Director, Legal – Clinical & Commercial Contracts. This role will be instrumental in supporting our clinical development and commercial operations as we advance our pipeline and bring therapies to patients. The ideal candidate will bring deep experience drafting, negotiating, and managing a wide variety of agreements that support a biopharmaceutical company's clinical trials and commercial activities.
Key Responsibilities:
- 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 agreement Commercial agreements including distribution, manufacturing and supply agreements, marketing and advertising contracts, patient support services agreements, and market access-related documents.
- Collaborate cross-functionally with clinical operations, regulatory, medical affairs, commercial, compliance, and business development teams to align legal strategy with business goals.
- Provide legal guidance on regulatory and compliance issues related to clinical and commercial activities, including FDA regulations, anti-kickback laws, and promotional practices.
- Support the contracting process from initiation to execution, ensuring contract templates and processes are up to date, efficient, and compliant.
- Help manage outside counsel and legal vendors related to clinical trials and commercial activities.
- Develop and deliver training and guidance to internal stakeholders on legal and compliance matters relevant to clinical development and commercialization.
- Participate in the development and implementation of scalable legal processes and policies to support a growing biopharma organization.
Qualifications:
- JD from an accredited law school; admitted to practice law in at least one U.S. jurisdiction.
- Minimum 7–10 years of relevant legal experience, preferably including in-house counsel experience at a clinical and/or commercial-stage biotech or pharmaceutical company.
- Deep understanding of the drug development lifecycle, GCP, and applicable healthcare and regulatory law.
- Demonstrated experience drafting and negotiating clinical trial and commercial agreements.
- Strong interpersonal and communication skills, with an ability to work collaboratively across functions and levels.
- Strategic thinker with sound business judgment and a proactive, solutions-oriented mindset.
- Experience working in rare diseases or specialty pharma a plus.
Preferred Skills:
- Familiarity with ex-US clinical and commercial contracting and legal considerations.
- Experience supporting product launches or commercialization of specialty or rare disease products.
Rezolute (RZLT) currently anticipates the base salary for the Director, Legal – Clinical & Commercial Contracts role could range from $235,000 to $295,000 and will depend, in part, on the successful candidate’s 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 Company’s 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.
