Associate Director, Safety Operations Portfolio
AbbVie
2 months ago
Remote friendly (Cambridge, MA)
United States
Operations
Purpose:
- Manage a team of Portfolio Leads and Product Leads responsible for Safety Operations-related scientific activities, input, and expertise across assets in all therapeutic areas. Lead the SOPROL (Safety Operations Product Leadership) team.
- Ensure accurate, high-quality, and timely Safety Operations scientific input and support are provided to PSTs across assets (development and on-market) from discovery to end of life.
Responsibilities:
- Develop, communicate, and implement the strategy for providing scientific expertise and support across Safety Operations activities (e.g., regulatory responses, submissions and launches, audits/inspections, clinical trial protocol reviews).
- Oversee the accuracy, quality, and timeliness of scientific input across the end-to-end Safety Operations activities for pharmaceutical and device assets; review content through an enterprise and international lens; direct SOPROL team members to enhance input quality.
- Interpret and implement global regulations related to clinical trials and pharmacovigilance; collaborate with the QPPV Office.
- Build collaborative relationships with PST Therapeutic Area leadership, Group Medical Directors, and senior leaders in Epidemiology, Medical Aesthetics & Device Safety, and Clinical Trial Safety & Insights; provide scientific recommendations to optimize safety strategies for high-profile assets.
- Apply pipeline/commercial priorities to ICSR forecasting and Safety Operations business planning.
- Prepare GPS leadership communications based on ICSR data insights.
- Manage talent development and utilization of SOPROL Portfolio Leads and Product Managers (engage, inspire, coach, mentor).
- Partner cross-functionally with Global Medical Affairs, Regulatory Affairs, Clinical Development, etc. to support high-quality scientific decision-making.
- Manage audit/inspection preparedness; prepare Portfolio Leads and Product Managers for product SME participation.
- Represent VP Safety Operations in senior leadership scientific discussions; serve on GPS scientific governance bodies as needed.
- Perform SOPROL responsibilities for sensitive/confidential assets (e.g., acquisitions and partnerships).
Qualifications:
- Minimum: Bachelor’s degree in related health sciences; Licensed healthcare professional preferred (RN, BSN, BS, BS Pharm, PharmD, or advanced degree preferred).
- At least 6 years healthcare industry experience with strong understanding of drug development.
- 4 years pharmacovigilance experience required.
- Minimum 3 years clinical development experience.
- Previous Pharmacovigilance leadership role preferred.
- Demonstrated collaboration with internal/external stakeholders (Affiliates, Health Authorities, third-party vendors) preferred.
- Significant experience leading cross-functional teams on complex projects required.
- Significant experience leading major change initiatives within a team required.
- Strong leadership presence; ability to challenge status quo and influence senior management.
- High emotional intelligence, relationship management, and communication skills.
- Understanding connections between regulations and science for drug safety.
Benefits:
- Paid time off (vacation, holidays, sick); medical/dental/vision insurance; 401(k) to eligible employees.
- Eligible for short-term incentive programs.
- Manage a team of Portfolio Leads and Product Leads responsible for Safety Operations-related scientific activities, input, and expertise across assets in all therapeutic areas. Lead the SOPROL (Safety Operations Product Leadership) team.
- Ensure accurate, high-quality, and timely Safety Operations scientific input and support are provided to PSTs across assets (development and on-market) from discovery to end of life.
Responsibilities:
- Develop, communicate, and implement the strategy for providing scientific expertise and support across Safety Operations activities (e.g., regulatory responses, submissions and launches, audits/inspections, clinical trial protocol reviews).
- Oversee the accuracy, quality, and timeliness of scientific input across the end-to-end Safety Operations activities for pharmaceutical and device assets; review content through an enterprise and international lens; direct SOPROL team members to enhance input quality.
- Interpret and implement global regulations related to clinical trials and pharmacovigilance; collaborate with the QPPV Office.
- Build collaborative relationships with PST Therapeutic Area leadership, Group Medical Directors, and senior leaders in Epidemiology, Medical Aesthetics & Device Safety, and Clinical Trial Safety & Insights; provide scientific recommendations to optimize safety strategies for high-profile assets.
- Apply pipeline/commercial priorities to ICSR forecasting and Safety Operations business planning.
- Prepare GPS leadership communications based on ICSR data insights.
- Manage talent development and utilization of SOPROL Portfolio Leads and Product Managers (engage, inspire, coach, mentor).
- Partner cross-functionally with Global Medical Affairs, Regulatory Affairs, Clinical Development, etc. to support high-quality scientific decision-making.
- Manage audit/inspection preparedness; prepare Portfolio Leads and Product Managers for product SME participation.
- Represent VP Safety Operations in senior leadership scientific discussions; serve on GPS scientific governance bodies as needed.
- Perform SOPROL responsibilities for sensitive/confidential assets (e.g., acquisitions and partnerships).
Qualifications:
- Minimum: Bachelor’s degree in related health sciences; Licensed healthcare professional preferred (RN, BSN, BS, BS Pharm, PharmD, or advanced degree preferred).
- At least 6 years healthcare industry experience with strong understanding of drug development.
- 4 years pharmacovigilance experience required.
- Minimum 3 years clinical development experience.
- Previous Pharmacovigilance leadership role preferred.
- Demonstrated collaboration with internal/external stakeholders (Affiliates, Health Authorities, third-party vendors) preferred.
- Significant experience leading cross-functional teams on complex projects required.
- Significant experience leading major change initiatives within a team required.
- Strong leadership presence; ability to challenge status quo and influence senior management.
- High emotional intelligence, relationship management, and communication skills.
- Understanding connections between regulations and science for drug safety.
Benefits:
- Paid time off (vacation, holidays, sick); medical/dental/vision insurance; 401(k) to eligible employees.
- Eligible for short-term incentive programs.