About the Company - Hamlyn Williams is partnered with a clinical-stage biotech company in the search for a Sr/Exec. Director, Drug Safety & PV, responsible for leading all aspects of drug safety and pharmacovigilance for the company's pipeline of products.

About the Role - This role reporting to the CMO requires a strategic thinker with extensive knowledge of regulatory requirements, risk management, medical monitoring and safety data analysis who is also willing and able to participate in daily operations of the clinical teams.

Responsibilities

• Develop and implement the pharmacovigilance strategy in alignment with regulatory requirements.
• Oversee the development of drug safety databases and reporting procedures to ensure regulatory compliance.
• Build and develop a team of drug safety professionals, both full-time and the overseeing of consultants, to evaluate and oversee safety reporting and management.
• Oversee the analysis and reporting of safety data from ongoing Ph. 1-3 clinical trials.
• Provide support for safety sections of clinical documents, including the review and approval of the safety portion of protocols, annual reports (DSUR), final study reports, IB and other documents.
• Lead the safety analysis for regulatory submissions including INDs, BLAs and MAAs.
• Ensure compliance with global regulatory requirements and guidelines, including those from the FDA, EMA, and ICH.
• Lead the preparation and submission of safety reports, incl. Periodic Safety Update Reports and other regulatory filings.
• Collaborate with Regulatory Affairs, Clinical Sciences and QA teams to ensure integrated approaches to drug safety. Provide expert safety guidance during development of protocols and other site-facing documents.
• Analyze safety data trends and provide actionable insights to senior management and stakeholders.
• Provide medical expertise to clinical teams in evaluation of safety events.

Qualifications - MD Required, Minimum of 10 years of Oncology experience required, Minimum of 15 years of experience in pharmacovigilance or drug safety, with at least 5 years in a leadership role

Pay range and compensation package - Pay range or salary or compensation

$270,000 - $320,000, depending on experience, plus bonus and equity