Associate Director, Safety Operations Portfolio
AbbVie
2 months ago
Remote friendly (South San Francisco, CA)
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, partnering with Therapeutic Area Heads and senior/executive scientific leaders across Global Patient Safety (GPS), Global Medical Affairs, Clinical Development, and Regulatory Affairs to ensure accurate, high-quality, and timely Safety Operations scientific input for PSTs 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 spectrum for pharmaceutical and device assets (development and on-market); provide direction to SOPROL team members.
- Interpret and implement global regulations related to clinical trials and pharmacovigilance; collaborate with the QPPV Office on international regulatory requirements.
- Build collaborative relationships with PST Therapeutic Area leadership, Group Medical Directors, and senior leaders (Epidemiology, Medical Aesthetics & Device Safety, Clinical Trial Safety & Insights); provide Safety Operations scientific recommendations to optimize safety strategies.
- Apply pipeline and commercial priority knowledge to recommend ICSR forecasting and broader Safety Operations business planning.
- Prepare GPS leadership communications using ICSR data to strengthen safety understanding, narratives, and actions.
- Manage talent development and utilization of SOPROL Portfolio Leads and Product Managers (engage, coach, mentor).
- Partner cross-functionally with Global Medical Affairs, Regulatory Affairs, Clinical Development, etc., to advance SOPROL priorities and support high-quality scientific decision-making and agility.
- Manage audit and inspection preparedness for PSTs; 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., acquisition deals and partnerships).
Qualifications:
Minimum:
- Bachelor’s degree with related health sciences background; licensed healthcare professional preferred (RN, BSN, BS, BS Pharm, PharmD, or advanced degree preferred).
- 6+ years healthcare industry experience with strong understanding of the drug development process.
- 4 years pharmacovigilance experience required.
- 3+ years clinical development experience.
- Understanding of the connections between regulations and science for drug safety.
Preferred:
- Previous Pharmacovigilance leadership role.
- Ability to collaborate with internal/external stakeholders (Affiliates, Health Authorities, third-party vendors).
- Significant experience leading cross-functional teams on complex projects.
- Significant experience leading major change initiatives.
- Strong leadership presence; ability to challenge the status quo and influence senior management.
- High emotional intelligence, relationship management, and communication skills.
Benefits (as stated):
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) for eligible employees.
- Eligibility 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, partnering with Therapeutic Area Heads and senior/executive scientific leaders across Global Patient Safety (GPS), Global Medical Affairs, Clinical Development, and Regulatory Affairs to ensure accurate, high-quality, and timely Safety Operations scientific input for PSTs 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 spectrum for pharmaceutical and device assets (development and on-market); provide direction to SOPROL team members.
- Interpret and implement global regulations related to clinical trials and pharmacovigilance; collaborate with the QPPV Office on international regulatory requirements.
- Build collaborative relationships with PST Therapeutic Area leadership, Group Medical Directors, and senior leaders (Epidemiology, Medical Aesthetics & Device Safety, Clinical Trial Safety & Insights); provide Safety Operations scientific recommendations to optimize safety strategies.
- Apply pipeline and commercial priority knowledge to recommend ICSR forecasting and broader Safety Operations business planning.
- Prepare GPS leadership communications using ICSR data to strengthen safety understanding, narratives, and actions.
- Manage talent development and utilization of SOPROL Portfolio Leads and Product Managers (engage, coach, mentor).
- Partner cross-functionally with Global Medical Affairs, Regulatory Affairs, Clinical Development, etc., to advance SOPROL priorities and support high-quality scientific decision-making and agility.
- Manage audit and inspection preparedness for PSTs; 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., acquisition deals and partnerships).
Qualifications:
Minimum:
- Bachelor’s degree with related health sciences background; licensed healthcare professional preferred (RN, BSN, BS, BS Pharm, PharmD, or advanced degree preferred).
- 6+ years healthcare industry experience with strong understanding of the drug development process.
- 4 years pharmacovigilance experience required.
- 3+ years clinical development experience.
- Understanding of the connections between regulations and science for drug safety.
Preferred:
- Previous Pharmacovigilance leadership role.
- Ability to collaborate with internal/external stakeholders (Affiliates, Health Authorities, third-party vendors).
- Significant experience leading cross-functional teams on complex projects.
- Significant experience leading major change initiatives.
- Strong leadership presence; ability to challenge the status quo and influence senior management.
- High emotional intelligence, relationship management, and communication skills.
Benefits (as stated):
- Paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) for eligible employees.
- Eligibility for short-term incentive programs.