Senior Director, Patient Safety Sciences - Oncology Leader

Olema Oncology; San Francisco (CA); Vor Ort; USD 270.000 - 310.000; Vollzeit

Zusammenfassung

Olema Oncology in San Francisco or Boston is seeking a Senior Director, Patient Safety Sciences to lead safety strategy across our oncology portfolio. You will report to the Vice President of Drug Safety and Pharmacovigilance and build a high-performing Safety Sciences team, integrating safety leadership into Clinical Development, Regulatory Affairs, Medical Affairs, and other functions.

You will develop pharmacovigilance plans, oversee SAE/SUSAR reviews, liaise with external stakeholders, and

Qualifikationen

• Minimum of 15 years' relevant experience in drug safety in biopharmaceutical industry, with oncology focus.
• Minimum of 6+ years of progressive people leadership experience.
• Experience in oncology; small molecule experience preferred.
• Proven ability to coach and develop teams and manage performance.

Aufgaben

• Lead strategy for patient safety activities across Olema’s development portfolio.
• Develop, coach, and mentor the Safety Sciences team.
• Coordinate cross-functional safety planning with Clinical Development, Regulatory, and Medical Affairs.
• Oversee safety reviews of SAEs and SUSARs and signal detection.
• Lead audits, inspections readiness, and quality systems in Safety Sciences.
• Develop safety training programs for staff.
• Represent safety perspectives in engagements with investigators and regulators.
• Provide safety input into regulatory submissions and DSURs.

Kenntnisse

Drug safety leadership

Oncology expertise

Pharmacovigilance

Regulatory knowledge

People leadership

Ausbildung

MD/PhD/PharmD or MD equivalent

Jobbeschreibung

Olema Oncology in San Francisco or Boston is seeking a Senior Director, Patient Safety Sciences to lead safety strategy across our oncology portfolio. You will report to the Vice President of Drug Safety and Pharmacovigilance and build a high-performing Safety Sciences team, integrating safety leadership into Clinical Development, Regulatory Affairs, Medical Affairs, and other functions.

You will develop pharmacovigilance plans, oversee SAE/SUSAR reviews, liaise with external stakeholders, and