Senior Director, Patient Safety Sciences - Oncology

OpenKrill; United States; Remote; USD 220,000 - 290,000; Full time

Job summary

Olema Oncology seeks a Senior Director of Safety Sciences to lead and shape the Safety Sciences function across our oncology portfolio. You will provide strategic and scientific leadership for planning, implementation, and oversight of patient safety activities, partnering with Clinical Development, Regulatory Affairs, and Medical Affairs.

You will build and coach a high-performing team, promote accountability and continuous learning, and represent safety perspectives with external stakeholders.

Qualifications

• MD, PhD, PharmD or MD-equivalent from an accredited institution.
• Extensive knowledge of ICH, FDA, and EU regulations governing patient safety and pharmacovigilance.
• Experience with registrational clinical development programs and filings.
• Strong leadership and mentoring experience in biopharma safety.
• Oncology industry experience required; small molecule experience preferred.
• Ability to collaborate across functions and external stakeholders.

Responsibilities

• Lead strategic planning and execution of patient safety activities with cross-functional partners.
• Develop and author safety sections of regulatory documents including benefit-risk assessments, protocols, and safety information.
• Review SAEs, SUSARs, and analyses of similar events; ensure accurate narratives and MedDRA coding.

Skills

Leadership

Pharmacovigilance

Oncology knowledge

Team development

Education

MD/PhD/PharmD

Job description

Olema Oncology seeks a Senior Director of Safety Sciences to lead and shape the Safety Sciences function across our oncology portfolio. You will provide strategic and scientific leadership for planning, implementation, and oversight of patient safety activities, partnering with Clinical Development, Regulatory Affairs, and Medical Affairs.

You will build and coach a high-performing team, promote accountability and continuous learning, and represent safety perspectives with external stakeholders.