Provides specialist medical/scientific strategic and operational input into core medical affairs activities such as: health-care professional/provider interactions; generation of clinical and scientific data; educational initiatives (medical education, data, guidelines and value proposition); safeguarding patient safety (risk minimization activities / safety surveillance activities). Works closely with sales, marketing and commercial teams to provide strategic medical input into core brand strategies, and to support medical/marketing activities and market access.
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Key Responsibilities Include:
Establishes and approves scientific methods for hypotheses, rational, design of affiliate/Area/Global protocols and their reports across different products.
Participation in design and execution of clinical trial safety, product safety and risk management plans. May also 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.
Oversees the conduct of clinical trials and is 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.
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.
Drives medical affairs activities and generation and dissemination of data supporting overall product scientific and business strategy. Coordinates induction, mentoring, training, and development. Identified training needs.
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. May develop of scientifically accurate marketing materials, medical education programs, advisories, and symposia.
Oversee 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.
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. Represents AbbVie at external meetings including investigator meetings, scientific association meetings, etc.
Assists with the scientific review, development, approval, execution and communication of affiliate/area/global 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.
Ensures budgets, timelines, compliance requirements are factored into programs' scientific activities.
Works independently. 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.
Qualifications
Basic:
Medical Doctorate (M.D.) degree or equivalent (D.O. or non-US equivalent of M.D. meet requirements) with relevant therapeutic specialty in an academic or hospital environment. Completion of residency and/or fellowship is preferred.
National license to practice medicine with relevant therapeutic specialty in an academic or hospital environment. Academic qualification (Dr med or equal). Completion of residency and/or fellowship is preferred. Advanced academic qualification is warranted.
Minimum of 5 years of clinical trial experience in the biotech/ pharmaceutical industry or academia or equivalent. 7+ years of experience is preferred.
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 clinical program 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 an understanding of Pharmacovigilance practices for Clinical Development programs.
Ability to interact externally and internally to support global business strategies.
Must possess excellent oral and written English communication skills.
Ex-Us: At least one further major international language is preferred.
Must have an in-depth understanding of the Clinical Development process for Phase I-IV or extensive knowledge of Pharmaceutical Development including compliance and regulatory requirements.
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