Rezolute, Inc.

Director / Senior Director, Pharmacovigilance Operations

Rezolute, Inc.  •  $255k - $315k/yr  •  Remote  •  3 hours ago
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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 mission is to bring hope and meaningful solutions to patients and families affected by rare and difficult-to-treat diseases through scientific innovation, collaboration, and integrity.

Rezolute’s lead investigational therapy, RZ358 (ersodetug), is a fully human monoclonal antibody in late-stage clinical development for the treatment of hypoglycemia due to congenital and acquired forms of hyperinsulinism (HI). As Rezolute expands its medical and scientific focus into tumor-related hyperinsulinism (tumor HI), most commonly related to pancreatic neuroendocrine tumors (insulinomas) or paraneoplastic hypoglycemia (NICTH), the company is committed to advancing novel therapeutic strategies that address this rare and complex form of hypoglycemia associated with insulin-secreting tumors and related neuro-oncology disorders

More information can be found at rezolutebio.com

The Director / Senior Director, Pharmacovigilance Operations will play a critical leadership role in building and executing the company’s pharmacovigilance and drug safety capabilities as the organization advances its lead product toward regulatory approval and commercial launch.

This individual will be responsible for ensuring an effective, scalable, and inspection-ready pharmacovigilance system supporting late-stage clinical development, regulatory submissions, product launch, and post-marketing safety surveillance. The role will provide leadership across safety operations, benefit-risk management, signal detection and management, aggregate reporting, safety governance, vendor oversight, and global regulatory compliance.

As the company evolves from a development-stage organization to a commercial biopharmaceutical company, the Director/Senior Director will help establish the people, processes, systems, governance, and external partnerships required for commercial pharmacovigilance.

The successful candidate will combine strong scientific and medical judgment with practical operational experience implementing pharmacovigilance capabilities in a growing organization.

Key Responsibilities

Pharmacovigilance Strategy & Leadership

  • Develop and execute the pharmacovigilance strategy supporting late-stage clinical development, regulatory approval, product launch, and post-marketing surveillance.
  • Establish a scalable PV operating model appropriate for the company's anticipated commercial footprint, product portfolio, geographic expansion, and partnership structure.
  • Serve as a senior safety leader and subject matter expert for pharmacovigilance matters across Clinical Development, Regulatory Affairs, Medical Affairs, Quality, Commercial, Legal, and other functions.
  • Provide safety input into clinical development plans, regulatory submissions, labeling strategies, launch-readiness activities, medical information processes, and lifecycle management.
  • Represent Pharmacovigilance on cross-functional governance and product development teams.
  • For the Senior Director level, provide strategic leadership to executive management regarding emerging safety issues, benefit-risk considerations, regulatory risk, and organizational PV capabilities.

Qualifications

Education

  • Advanced degree in a health or life sciences discipline strongly preferred, such as MD, PharmD, PhD, RN/NP, or equivalent scientific/medical training.
  • Candidates with a master's or bachelor's degree and significant relevant pharmacovigilance leadership experience may also be considered.

Rezolute (RZLT) currently anticipates the base salary for the Director / Senior Director, Pharmacovigilance Operations role could range from $255,000 to $315,000 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.

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.

Rezolute, Inc.

About Rezolute, Inc.

Rezolute is a late-stage rare disease company focused on significantly improving outcomes for individuals with hypoglycemia caused by hyperinsulinism (HI).

For more information, visit: www.rezolutebio.com.

Industry
Biotech & Life Sciences
Company Size
51-200 employees
Headquarters
Redwood City, California
Year Founded
Unknown
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