---
title: 'Director of Medical Affairs Operations at Rezolute'
canonical: 'https://feeny.ai/job/director-of-medical-affairs-operations-rezolute-redwood-city-ck5kj9c3wbfs'
type: 'job'
last_seen: '2026-09-11'
---

# Director of Medical Affairs Operations at Rezolute

- **Company:** Rezolute
- **Location:** Redwood City, CA
- **Employment:** full-time
- **Work type:** onsite
- **Posted:** 2026-08-26
- **Last confirmed live:** 2026-09-11
- **Apply:** https://jobs.lever.co/rezolutebio/3bbee9c7-1dea-4ab6-8966-ce131b8d7806

## Job description

Rezolute is a late-stage rare disease biopharmaceutical company focused on developing transformative therapies for patients living with severe metabolic and endocrine disorders. Our lead investigational therapy, RZ358 (ersodetug), is a fully human monoclonal antibody in late-stage clinical development for the treatment of congenital and acquired forms of hyperinsulinism (HI). Rezolute’s mission is to bring hope and meaningful solutions to patients and families affected by rare diseases through scientific innovation, collaboration, and integrity.

The Director of Medical Affairs Operations will play a pivotal role in working alongside the Vice President of Medical  Affairs to shape and execute the medical and product launch strategy for Rezolute’s rare disease portfolio. This role will assist in developing and implementing medical affairs strategies, working cross functionally to oversee projects in medical communications, engagement with key opinion leaders (KOLs) and other key healthcare professionals (HCPs). This role requires a balance of strategic thinking and operational execution, with an emphasis on project management and cross-functional collaboration and stakeholder communication, both internally and externally.  This role will be integral to operationalizing critical components of the medical affairs department to ensure a successful product launch and sustained post-launch support.

## Key Responsibilities

1. Planning and Leadership

- Provide insights into the development and implementation of the medical affairs strategy to support the successful launch of rare disease products
- Collaborate cross-functionally with clinical, commercial, and regulatory teams to ensure alignment on pre- and post-launch activities.
- Partner with senior leaders to develop and execute the Medical Affairs strategy in alignment with organizational objectives.

1. Governance and Operational Excellence:

- Drive operational efficiency by streamlining processes, workflows, and systems within Medical Affairs.
- Enhance and oversee metrics and KPIs to track performance, ensuring continuous improvement.
- Develop and maintain governance frameworks to support compliance, quality, and risk management.
- Support the Medical Affairs system and technology roadmap to support business objectives of Medical Affairs
- Support the assessment of future technologies for the department and helps direct departmental implementation of new technologies
- Partner with IT to ensure project goals are in line with global business plans of action and project plans are tracked.
- Partner with Finance to ensure international projects are managed with fiscal discipline and track to budget.
- MSL field team effectiveness: Enhance and oversee metrics and KPIs to track performance, ensuring continuous improvement.

1. Cross-Functional Collaboration:

- Serve as a key liaison between Medical Affairs and other functions (Commercial, Development, Manufacturing, etc.) to ensure alignment and coordination.
- Facilitate effective communication and information sharing to drive seamless execution of medical strategies.
- Share in oversight of the development and dissemination of scientifically accurate and compliant medical content, including publications, slide decks, and digital assets.
- Ensure alignment of medical communications with the company's broader scientific and clinical objectives
- Collate actionable MSL field insights to inform medical and commercial strategies.
- Help guide the creation of medical education and training materials for internal and external stakeholders.

1. Program and Project Management:

- Oversee the implementation of strategic initiatives, ensuring delivery on time and within scope.
- Manage cross-functional project teams to execute high-impact projects that support Medical Affairs priorities.
- Create dashboards and reporting systems to track the progress of key initiatives.
- Liaison with external vendors and agencies supporting medical communications and publications.
- Co-develop performance metrics and provide coaching to optimize MSL impact on scientific exchange and KOL engagement.

1. Key Opinion Leader (KOL) Engagement

- Develop and maintain strong relationships with global, national, and regional KOLs in the rare disease space.
- Facilitate scientific exchange and education to advance understanding of the company’s products and therapeutic areas.
- Identify and collaborate with external experts for advisory boards, symposia, and scientific meetings.

## Qualifications

- Minimum of 7 years of experience in medical affairs leadership within the biopharmaceutical industry, preferably in rare diseases with a minimum of a BS degree in life science, advanced degrees (MS, PhD, MBA) are preferred
- Proven leadership experience in medical affairs with successful product launches, with experience in medical affairs operations including medical communication, and KOL engagement.
- Strong leadership and project management experience,
- Exceptional communication and interpersonal skills with the ability to influence cross-functional teams.
- Deep understanding of rare disease therapeutic areas and related regulatory requirements.
- Experience in designing and executing advisory boards, symposia, or investigator-initiated studies.
- Familiarity with health economics and outcomes research (HEOR) to support value messaging in rare diseases.
- Demonstrated ability to build strong relationships with external stakeholders.

Rezolute (RZLT) currently anticipates the base salary for the Director of Medical Affairs  role could range from $000,000 to $000,000 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.

## About Rezolute

## Company Overview
- **One-liner**: Rezolute is a late-stage rare disease biotechnology company developing ersodetug, a monoclonal antibody therapy for hypoglycemia caused by congenital and tumor hyperinsulinism.
- **Entity Type**: Public (Nasdaq: RZLT)
- **Headquarters**: Redwood City, California, United States (with an additional office in Louisville)
- **Founded**: Not publicly available (IPO 2012)
- **Founders**: Not publicly available

## Core Business
- **Primary industry**: Biotechnology – rare disease therapeutics
- **Target customers**: B2B – healthcare providers, patients, and payers; focuses on addressing severe unmet medical needs in hyperinsulinism
- **Mission/purpose**: Significantly improve outcomes for individuals with hypoglycemia caused by hyperinsulinism ([rezolutebio.com – About](https://rezolutebio.com/job-openings/))

## Products & Services
- **Ersodetug (lead candidate)**: An intravenously administered human monoclonal antibody that allosterically binds to the insulin receptor, down‑modulating insulin action to restore normal glucose levels. Being developed for two indications:
  - **Congenital Hyperinsulinism (sunRIZE Phase 3 study)** – completed enrollment (May 2025) with 62 participants; topline results expected December 2025.
  - **Tumor Hyperinsulinism (upLIFT Phase 3 study)** – initiated mid‑2025; FDA agreed to a single‑arm open‑label design; topline results expected second half 2026.
  - Designations: Orphan Drug (US/EU), Rare Pediatric Disease, Breakthrough Therapy (US), PRIME (EU), ILAP (UK) ([ir.rezolutebio.com – 10-K](https://ir.rezolutebio.com/sec-filings/content/0001104659-25-090848/0001104659-25-090848.pdf))

## Market Standing
- **Valuation/Market Cap**: $317.7 million (as of recent data, per LinkedIn) ([linkedin.com](https://linkedin.com/company/rezolute))
- **Key Metric (Public)**: Annual revenue of $14.1 million (likely from grants or collaboration revenue; no product revenue yet) ([linkedin.com](https://linkedin.com/company/rezolute))
- **Notable Investors/Partners**: Not publicly available – company is publicly traded and does not disclose a lead investor list. Key partners include clinical trial sites and regulatory agencies (FDA, EMA).
- **Growth Signals**:
  - Headcount: 50 employees (+2.9% YoY) ([linkedin.com](https://linkedin.com/company/rezolute))
  - Phase 3 sunRIZE study fully enrolled; topline data pending December 2025.
  - Phase 3 upLIFT study enrolling with streamlined design; data expected second half 2026.
  - FDA granted Breakthrough Therapy Designation for tumor HI in May 2025.
  - Multiple regulatory designations accelerating development pathway.

## Competitive Advantages
- **Unique mechanism**: Ersodetug acts downstream from beta cells at the insulin receptor, allowing it to potentially treat all forms of hyperinsulinism (genetic or acquired) regardless of underlying cause.
- **Dosing convenience**: Half‑life >2 weeks enables monthly intravenous administration.
- **Regulatory momentum**: Orphan Drug, Rare Pediatric Disease, Breakthrough Therapy, PRIME, and ILAP designations provide expedited review, potential priority review voucher, and closer FDA/EMA collaboration.
- **Pivotal data catalysts**: Two Phase 3 studies read out within ~12‑18 months, creating clear value inflection points.

## Strategic Focus
- Execute the two ongoing Phase 3 trials (sunRIZE in congenital HI, upLIFT in tumor HI).
- Assuming positive topline data from sunRIZE, submit a Biologics License Application (BLA) to the FDA for ersodetug in mid‑2026.
- Continue to build commercial and medical affairs infrastructure (recent job postings indicate hires in Commercial Operations, Marketing, Payer Strategy, and Supply Chain) ([rezolutebio.com – Job Openings](https://rezolutebio.com/job-openings/)).

## Why Work Here
- **Mission‑driven**: Employees work on therapies for ultra‑rare, life‑threatening conditions with high unmet medical need.
- **Benefits**: Comprehensive health/dental/vision insurance, competitive salaries, annual bonus, 401(k) with company match, tuition assistance, on‑site meals, flexible spending accounts ([rezolutebio.com – Benefits](https://rezolutebio.com/job-openings/)).
- **Work environment**: Hybrid/office policy not explicitly stated; roles are based in Redwood City (HQ) and Louisville. Recent openings include remote-friendly functions? Not confirmed.
- **Growth opportunity**: Small company (~50 people) entering late‑stage development and pre‑commercial build‑out – employees can have broad impact and career advancement.
- **Engineering culture**: For biotech, the focus is on clinical operations, regulatory, and commercial roles rather than traditional engineering. IT positions (Business System Engineer) exist.

## Sources
1. [linkedin.com – Rezolute company page](https://linkedin.com/company/rezolute)
2. [rezolutebio.com – Job Openings & Benefits](https://rezolutebio.com/job-openings/)
3. [ir.rezolutebio.com – SEC 10-K Filing (September 2025)](https://ir.rezolutebio.com/sec-filings/content/0001104659-25-090848/0001104659-25-090848.pdf)
4. [rezolutebio.com – Leadership page](https://rezolutebio.com/leadership/)

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- [Senior Manager, External Supplier Operations](https://feeny.ai/job/senior-manager-external-supplier-operations-rezolute-redwood-city-pqxs0q5vsnyp) — Redwood City, CA
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- [Director Program Manager, Product Launch (Rare Disease)](https://feeny.ai/job/director-program-manager-product-launch-rare-disease-rezolute-redwood-city-vn56yjrm5v16) — Redwood City, CA
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