Group Medical Director, Clinical Trial Safety

About AbbVie
AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter , Facebook , Instagram , YouTube and LinkedIn .

The Pharmacovigilance and Patient Safety (PPS) organization works closely and strategically with colleagues across the product lifecycle to identify, evaluate, understand and communicate the safety profile of AbbVie's products to protect patients worldwide. Group Lead, Clinical Trial Safety, Area PV Products reports VP, Clinical Trial Safety and Insights and is responsible for leading a team of pharmacovigilance professionals to direct the clinical trial safety strategy across the organization to drive scale and innovation with respect to clinical trial safety collection, analysis and deliverables and to develop enhanced capabilities and innovation in the clinical trial space.

Key Responsibilities:

• Responsible for the medical input and quality of all clinical trial safety deliverables including DSUR, IB, Safety Statistical Analysis Plans, Safety Monitoring Committees and Reference Safety Information
• Leads team to provide global medical and scientific safety expertise across key assets
• Strategic leadership on best practices and approaches related to clinical trial safety analysis, monitoring and communication globally across therapeutic areas
• Provides medical leadership to the team on methodologies and considerations for clinical trial adverse drug reaction identification, characterization and communication
• Collaborates with and provides SME guidance to PPS leadership at all levels regarding issues of safety science and strategy for significant clinical trial safety deliverables.
• Expert knowledge of the content and strategic approaches to safety deliverables in the clinical trials space, urgent safety measures to protect patients, DSUR, IB, reference safety information
• Develops the approach for aligning strategy related to safety deliverables globally, provides guidance regarding the execution of strategy across all therapeutic areas
• In collaboration with the patient integration team and PST, develops industry leading approaches and medical perspective for patient facing clinical trial safety documents such as informed consent, safety communications, urgent safety measures
• Leads PV medical aspects to cross company collaborations to deliver processes that are agile and adaptable to changing regulations
• PPS medical contact for initiatives across therapeutic areas related to clinical trial strategy and execution working in partnership with regulatory, compliance, clinical development and operations, site management and monitoring including IDMC, Safety Monitoring Committees, Unanticipated Problem
• Applies principles of pharmacology, chemistry, toxicology, pharmacokinetics to consult with PST and Safety decision Sciences on medical approaches to aggregate analysis, filings, regulatory responses and communication in the clinical trial space
• Provides strategic direction on regulatory responses related to reference safety information, USM/UP and the evolving clinical trial regulation across therapeutic areas
• Builds collaborative working relationships across the enterprise ensuring strategic input to clinical teams, regulatory and QA worldwide to drive innovation, communication and influence decision making
• Contribute to creating and communicating a culture which attracts, retains and develops the team at all levels in order to maximize contributions to the function and business

Qualifications

Qualifications:

Required Education:

• MD, DO with clinical practice as an attending
• Additional graduate degree in public health, pharmacy, health economics or related fields is preferred

Required Experience:

• 7-10 years clinical trial experience either in an academic setting, contract research organization (CRO) or pharmaceutical industry
• 5 years pharmacovigilance and/or patient safety experience
• Residency with direct patient management and care of patients is required

Competencies:

• Dynamic purposeful leader
• Effectively analyze and guide analysis of clinical data and epidemiological information
• Effectively present recommendation / opinions in group environment
• Proven ability to influence and motivate
• Deals effectively in areas of uncertainty
• Outstanding written and verbal communication skills with "Executive Presence"
• Maintains an enterprise, rather than a functional perspective, and acting on belief that solutions and plans are stronger when appropriate collaboration occurs across and beyond his/her organization
• Highly developed collaborative leadership skills and ability to build alignment around a common vision by providing clarity, support and tools needed to excel in a changing environment while collaborating with diverse stakeholders

Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel
Yes, 20 % of the Time
Job Type
Experienced
Schedule
Full-time
Job Level Code
E
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic.