Senior Director, Patient Safety Sciences

Scorpion Therapeutics; Cambridge (MA); On-site; USD 250,000 - 320,000; Full time

Job summary

Olema is seeking a Senior Director, Patient Safety Sciences to lead the safety functions across its oncology development portfolio and provide strategic and scientific leadership for patient safety activities within clinical programs. This role will build and develop a high-performing Safety Sciences team and ensure compliance with regulatory standards.

Location options include San Francisco or Boston with minimal travel; requires 15+ years in drug safety with oncology trial experience and 6+

Qualifications

• MD, PhD, PharmD, or equivalent required.
• 15+ years in drug safety with oncology clinical trial experience.
• 6+ years of leadership managing safety teams.
• Strong knowledge of ICH, FDA, and EU regulations.
• Experience with registrational trials and regulatory filings.
• Expertise in signal detection, benefit-risk evaluation, and pharmacovigilance audits.

Responsibilities

• Oversee safety signal detection, risk management strategies, and safety data analysis.
• Develop safety documentation such as benefit-risk assessments, protocols, and regulatory submissions.
• Review serious adverse events and support Data Monitoring Committees.
• Lead quality systems, audits, and inspections.
• Deliver safety training.
• Collaborate with Clinical Development, Regulatory Affairs, and Medical Affairs.
• Manage vendor relationships.

Skills

Leadership

Drug safety

Regulatory knowledge

Pharmacovigilance

Signal detection

Clinical trial safety

Education

MD/PhD/PharmD or equivalent

Job description

Role: Senior Director, Patient Safety Sciences, leading Olema's safety functions within its oncology development portfolio. Objectives: provide strategic and scientific leadership for patient safety activities across clinical programs, build and develop a high-performing Safety Sciences team, and ensure compliance with regulatory standards.

Responsibilities

• oversee safety signal detection, risk management strategies, and safety data analysis
• develop safety documentation such as benefit-risk assessments, protocols, and regulatory submissions
• review serious adverse events and support Data Monitoring Committees
• lead quality systems, audits, and inspections
• deliver safety training
• collaborate with Clinical Development, Regulatory Affairs, and Medical Affairs
• and manage vendor relationships

Requirements

• MD, PhD, PharmD, or equivalent
• 15+ years in drug safety with oncology clinical trial experience
• 6+ years of leadership managing safety teams
• strong knowledge of ICH, FDA, and EU regulations
• experience with registrational trials and regulatory filings
• expertise in signal detection, benefit-risk evaluation, and pharmacovigilance audits

Preferred

experience with small molecules and supporting safety in product development.

High-Value

• oncology focus
• biologics/pharmaceuticals
• late-stage clinical development
• pharmacovigilance leadership
• regulatory inspection support

Location

San Francisco or Boston; minimal travel.