The Therapeutic Area (TA) Lead is responsible for leading a team in Women's Health in developing and executing the Medical Affairs strategy for an AbbVie asset in development or a marketed product. Responsible for practical and clinically meaningful data strategy and delivery to inform clinical use and transform standard of care. Aligning all internal parties on Medical Benefit-Risk Evidence based positions. Deeply understanding the patient journey and apply insights into determining the medical need. Expected to work closely with Clinical Development and Asset Teams to ensure that global customer insights and health care practices, current and future are incorporated in the clinical development and regulatory plans. Provide strategic medical input into core brand strategies, and to support medical activities and market access.
Key Responsibilities Include:
- Actively participates in advancing and communicating corporate and US Medical Affairs philosophy and agenda. Participates as a member of TA Management. Coordinates induction, mentoring, training, and development of team. Identifies training needs. May supervise 2-10 employees, including other MDs or PhDs. Responsible for the Women’s Health Medical Science Liaison team through the National MSL Director. Responsible for all aspects of talent management for own team and provides feedback as part of TA management. May assist in developing/mentoring junior medical affairs staff.
- Participates in design and execution of clinical trial safety, product safety and risk management plans. May also carry responsibility for routine and adhoc safety monitoring reports to regulatory agencies. May review, assess and report applicable Adverse Events (AE’s) and Serious Adverse Events (SAE’s) if assigned to AbbVie conduct on clinical studies.
- Oversees the conduct of clinical trials and is medically and scientifically accountable for resolution of safety (AE’s & SAE’s) issues, interpretation of statistical analyses for clinical significance, PI selection, scientific documents reporting safety monitoring and other scientific reports submitted to the regulatory authorities.
- All clinical research / development activities for products under development, and for post approval commitments such as regulatory agency mandated trials, or those intended to support product registration or to generate data for label inclusion remain the primary responsibility of TA development teams. Assists with the scientific review, development, approval, execution and communication of affiliate/area/global medical affairs sponsored or supported clinical research activities.
- Drives medical affairs activities and generation and dissemination of data supporting overall product scientific and business strategy. May interact with and coordinates appropriate scientific and medical activities with internal stakeholders (i.e. commercial, clinical operations, discovery, statistics, regulatory, etc…) as they relate to on-going medical affairs projects.
- Oversees scientific/medical education of investigators, clinical monitors, and Global Project Team members related to therapeutic area or disease specific information. Keeps abreast of professional information and technology through conferences and/or medical literature and acts as a therapeutic area resource. May develop scientifically accurate marketing materials, medical education programs, advisories, and symposia. Maintains an up-to-date analysis of competitor product information.
- May act as consultant/liaison with other corporations when working under licensing agreements and/or in the evaluation of new business development opportunities. Represents AbbVie at external meetings including investigator meetings, scientific association meetings, etc. May act as medical/scientific leader for several programs within an area. May represent the medical function on cross-functional integrated teams for medical affairs activities.
- Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. Serves as the scientific team interface for key regulatory discussions.
- Drives Medical Affairs strategies and is a key internal contact/subject matter expert. May lead cross functional teams in development and execution of strategic initiatives requiring integration of multiple subprojects within the therapeutic area or Medical Affairs function. Ensures budgets, timelines, compliance requirements are factored into programs' scientific activities.
- Accountable for the medical review of complex advertising and promotional materials for assigned therapeutic area(s) within Medical Affairs. Provides strategic guidance to cross-functional team members related to the medical content. Maintains oversight of TA specific medical content included in commercial communications.
- Advanced degree (MD, PhD, DO) with relevant therapeutic specialty in an academic or hospital environment highly preferred. Relevant therapeutic area clinical experience and/or Medical Affairs in an academic, hospital or pharma environment required.
- OB-GYN, obstetrician-gynecologist highly preferred for the role.
- National license to practice medicine with relevant therapeutic specialty in an academic or hospital environment. Academic qualification (Dr med or equal) is strongly preferred. Completion of residency and/or fellowship is preferred. Advanced academic qualification is warranted.
- Typically 8 years of clinical trial or medical affairs experience in the pharmaceutical industry or academia or equivalent.
- Proven leadership skills in a cross-functional global team environment. Ability to interact externally and internally to support global business strategy. Ability to run a complex medical affairs team(s) independently.
- Extensive knowledge of clinical trial methodology, regulatory requirements governing clinical trials and experience in development strategy and the design of protocols. Expert knowledge in a relevant therapeutic specialty. Must have basic understanding of Pharmacovigilance practices for Clinical Development programs.
- Demonstrated sense of urgency and strong goal orientation, an ability to make decisions and a history of meeting deadlines and objectives.
- Works independently and leads team.
- Can address complex problems within discipline or across several projects.
- Exercises judgment within broadly defined practices and policies in selecting methods and techniques for obtaining solutions.
- Works on complex problems in which analysis of situation or data requires an in-depth evaluation of various complex factors
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel: Yes, 15 % of the Time
Job Type: Experienced