Senior Medical Director, Medical Affairs

Summary

Join AbbVie as a Senior Medical Director and provide specialist medical/scientific strategic and operational input into core medical affairs activities. You will interact with healthcare professionals, generate clinical data, lead educational initiatives, and ensure patient safety. Collaboration with sales, marketing, and commercial teams is crucial for strategic medical input into brand strategies. This role involves scientific support for assigned products, presentations, relationship building with key opinion leaders, and development of medical affairs strategies. You will also develop research concepts, provide training, and oversee clinical trials.

Requirements

• Medical Doctorate (M.D.) degree or equivalent (D.O. or non-US equivalent of M.D. with relevant therapeutic specialty in an academic or hospital environment
• Minimum of 5 years of clinical trial experience in the biotech/ pharmaceutical industry or academia or equivalent
• Proven leadership skills in a cross-functional team environment
• Ability to run a clinical program or medical affairs team(s) independently with little supervision
• Extensive knowledge of clinical trial methodology, regulatory requirements governing clinical trials and experience in developmental strategy and the protocols
• Expert knowledge in a relevant therapeutic specialty
• Understanding of the Pharmacovigilance practices for Clinical Development programs
• In-depth understanding of the Clinical Development process for Phase I-IV or extensive knowledge of Pharmaceutical Development including compliance and regulatory requirements
• Excellent oral and written English communication skills
• Ability to interact externally and internally to support business strategy

Responsibilities

• Establish and approve scientific methods for hypotheses, rationale, design of affiliate/Area protocols and their reports across different products
• Oversee the conduct of clinical trials and be medically and scientifically accountable for resolution of safety issues, interpretation of statistical analyses for clinical significance, PI selection, scientific documents reporting safety monitoring and other scientific reports submitted to the regulatory authorities
• Participate in design and execution of clinical trial safety, product safety and risk management plans
• May carry responsibility for safety monitoring reports to regulatory agencies
• May review, assess and report applicable Adverse Events and Serious Adverse Events if assigned to AbbVie conduct on clinical studies
• Drive medical affairs activities and generation and dissemination of data supporting overall product scientific and business strategy
• Coordinate induction, mentoring, training, and development
• Identify training needs
• Interact with and coordinate 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
• May develop scientifically accurate marketing materials, medical education programs, advisories, and symposia
• Oversee scientific/medical education of investigators, clinical monitors, and Project Team members related to therapeutic area or disease specific information
• Keep abreast of professional information and technology through conferences and/or medical literature and act as a therapeutic area resource
• Be responsible for understanding the regulatory requirements related to the clinical studies and global drug development and be accountable for complying with those requirements
• Serve as the scientific team interface for key regulatory discussions
• Represent AbbVie at external meetings including investigator meetings, scientific association meetings, etc
• Assist with the scientific review, development, approval, execution and communication of affiliate/area medical affairs sponsored or supported clinical research activities
• 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
• Ensure budgets, timelines, compliance requirements are factored into programs' scientific activities
• Work independently
• Address complex problems within discipline or across several projects
• Exercise judgment within broadly defined practices and policies in selecting methods and techniques for obtaining solutions
• Work on complex problems in which analysis of situation or data requires an in-depth evaluation of various complex factors

Preferred Qualifications

• Completion of residency and/or fellowship
• National license to practice medicine
• 7+ years of experience
• People management experience
• Experience in a senior role in a TA
• International experience

Benefits

• Paid time off (vacation, holidays, sick)
• Medical/dental/vision insurance
• 401(k)
• Short-term incentive programs
• Long-term incentive programs