Senior Director Drug Safety/Pharmacovigilance and ...

Rezolute Inc. is a clinical-stage biopharmaceutical company committed to developing transformative therapies for rare and metabolic diseases. Our innovative pipeline is focused on addressing significant unmet medical needs, and we are driven by a passion for scientific excellence and patient-centric approaches.Position Overview:Rezolute Inc. is seeking a highly experienced and strategic leader to join our team as the Senior Director/Executive Director, Drug Safety/ Pharmacovigilance and Clinical Development. This individual will be responsible for leading the Drug Safety and Pharmacovigilance (DSPV) function and Medical Monitoring responsibilities across the company's pipeline, ensuring robust safety surveillance, risk management, and compliance with global regulatory requirements per ICH/GCP guidelines. This role will report directly to the Senior Vice President of Clinical Development and will work collaboratively with cross-functional teams to advance the company's clinical development programs. Candidates with clinical development experience are highly preferred, as this role will interface closely with Clinical Development to inform strategic decision-making and ensure patient safety throughout the lifecycle of Rezolute's investigational products.Key Responsibilities:Provide strategic leadership and oversight for all drug safety and pharmacovigilance activities across Rezolute's clinical programs.Develop and implement the overall safety strategy and risk management plans for investigational products, ensuring alignment with corporate objectives and regulatory expectations.Oversee signal detection, safety surveillance, and risk-benefit assessments for products in development.Lead the development and maintenance of Safety Management Plans (SMPs), Risk Management Plans (RMPs), and Development Safety Update Reports (DSURs).Serve as the primary point of contact for health authorities regarding safety-related matters and participate in regulatory interactions, inspections, and audits.Oversee the collection, assessment, and reporting of adverse events (AEs), serious adverse events (SAEs), and other safety data in compliance with global regulatory requirements (e.g., FDA, EMA, MHRA, PMDA).Collaborate closely with Clinical Development, Regulatory Affairs, and Medical Affairs to ensure integration of safety data into clinical trial design, regulatory filings, and labeling.Lead cross-functional Safety Review Committees (SRCs) and contribute to the overall clinical development strategy by providing safety input and guidance.Establish and manage relationships with external pharmacovigilance vendors, ensuring high-quality case processing and aggregate reporting.Develop and mentor a high-performing safety team, fostering a culture of accountability, collaboration, and scientific excellence.Ensure that all safety processes and systems are compliant with Good Pharmacovigilance Practices (GVP) and are audit-ready.Contribute to the design and execution of clinical trials, providing safety oversight and input on protocol development, investigator brochures, and informed consent documents.May require travelling (not exceeding 15% of the total time) Qualifications:MD with extensive experience in drug safety, pharmacovigilance, or clinical development in the biotechnology or pharmaceutical industry.12+ years of experience in drug safety/pharmacovigilance.Strong knowledge of global pharmacovigilance regulations, including FDA, EMA, and ICH guidelines.Proven track record of successful interactions with regulatory agencies and leading safety sections of regulatory submissions (e.g., INDs, NDAs, BLAs, CTDs).Experience with risk management, signal detection, and aggregate safety reporting.Clinical development experience, including participation in clinical trial design, SRCs, and data monitoring committees, is a significant plus.Strong analytical, organizational, and communication skills with the ability to present complex safety data to diverse audiences.Demonstrated ability to lead and inspire cross-functional teams in a fast-paced, dynamic environment.Hands-on experience in early to late-stage clinical development programs, with the ability to provide end-to-end safety oversight.Experience working in rare diseases or metabolic disorders is a plus.To ApplyInterested and qualified candidates should send a resume to recruiting@ to the attention of Human Resources.Rezolute (RZLT) currently anticipates the base salary for the Senior Director Drug Safety/Pharmacovigilance and Clinical Development role could range from $315,000 to $345,000 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 InsuranceHoliday PayTracking Free Vacation Program401(k) Plan MatchEducational Assistance BenefitFitness Center ReimbursementWe 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.

Created: 2025-01-16