Associate Director, Safety Sciences

About the Role >>> Associate Director, Safety Sciences

As the Associate Director, Safety Sciences reporting to the Senior Director of Safety Sciences, you will serve as a safety science expert to support the development of Olema's products. You will work effectively with cross-functional teams across the organization as well as with external stakeholders, such as business partners and safety vendors/contractors.

This role is based out of our San Francisco or Boston office and will require less than 10% travel

Your work will primarily encompass:

• Conduct signal detection activities and analyses of safety data to support appropriate benefit-risk assessment
• Perform signal evaluation for identified safety signal and author safety evaluation reports
• Manage preparation and completion of safety documents, including [DSURs, PADERs/PBRERs, RMPs, and safety sections of protocols, reference safety information for IBs, ICFs, briefing books, NDA, and CCDS, etc.]
• Participate/lead responses to regulatory inquiries and other risk management activities
• Support clinical/medical review of SAEs, AESI, SUSARs, and Analysis of Similar Events (AOSE), as required, including reviewing source documents, reviewing case narrative for accuracy, reviewing MedDRA coding for appropriateness, identifying medically relevant queries, confirming event expectedness, and preparing sponsor assessment, and assisting Safety Operations staff in determining reportability
• Conduct literature search activities and develops key strings for search criteria and review information
• Support and attend Data Monitoring Committee (DMC) meetings, as required
• Support quality systems, inspection readiness, audit, and inspections
• Actively participate in process improvement initiatives, e.g. the development and maintenance of relevant SOPs
• Work effectively with cross-functional teams across the organization as well as with external stakeholders, including business partners and safety vendors/contractors
• Apply effective communication skills to lead and facilitate safety team meetings
• Apply relevant FDA, EU, and ICH guidelines, initiatives, and regulations governing pharmacovigilance activities

Ideal Candidate Profile >>>

A love of challenging, important work. We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives. All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture. As such, we are looking for someone with the right combination of knowledge, experience, and attributes for this role.

Knowledge:

• MD, PhD in the field of medical/biological science, PharmD, or RN degree
• Small Molecule and Oncology is a must

Experience:

• 5+ (MD, PhD, PharmD) or 8+ (RN) years of pharmacovigilance/drug safety experience in biopharmaceutical industry
• Actively participated in process improvement initiatives e.g. the development and maintenance of relevant SOPs and supporting documents
• Ability to apply relevant FDA, EU and ICH guidelines, initiatives and regulations governing pharmacovigilance activities
• Experience working with business partners and managing safety vendors
• Ability to work with the safety database for purposes of clinical/medical case review and simple queries
• Familiar with the clinical database/EDC
• Experience mentoring and teaching new/junior team members

Attributes:

• Able to manage time effectively, prioritize competing tasks, and consistently meet deadlines
• Strong verbal and written skills to convey safety findings and recommendations with clarity
• Excellent analytical, problem-solving, strategic planning, and interpersonal skills
• Self-motivated and enthusiastic; fast learner who can identify the core project challenges and expeditiously change courses as required in a fast-paced organization
• Demonstrates sound judgment, professionalism, and strong ethical standards

The base pay range for this position is expected to be $195,000 - $210,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience. The total compensation package for this position also includes equity, bonus, and benefits.

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