Medical Director/Scientific Director, Medical Affairs

4 weeks ago

Florham Park, New Jersey, United States AbbVie Full time
Job Description

AbbVie is seeking a highly skilled Medical Director/Scientific Director to join our Medical Affairs team. As a key member of our team, you will provide strategic medical and scientific input into core medical affairs activities, including health-care professional and provider interactions, generation of clinical and scientific data, educational initiatives, and safeguarding patient safety.

Responsibilities:

  • Initiates medical affairs activities, generation and dissemination of data supporting the overall scientific strategy.
  • Has overall responsibility for oversight of clinical studies, monitoring overall study integrity and review, interpretation and communication of accumulating data pertaining to safety and efficacy of the molecule.
  • May assist in the development of scientifically accurate marketing materials, medical education programs, advisories, and symposia.
  • Assists with the scientific review, development, approval, execution, and communication of affiliate/area/global medical affairs sponsored or supported clinical research activities.
  • May interact with and coordinate appropriate scientific and medical activities with internal stakeholders as they relate to on-going medical affairs projects.
  • Serves as the scientific team interface for key regulatory discussions.
  • Provide scientific/medical education to 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.
  • Ensures budgets, timelines, compliance requirements are factored into programs' scientific activities.
  • Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements.
  • Responsible from Global Medical Affairs for the design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study Reports and regulatory submissions and responses.
  • 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.
  • Participation in design and execution of clinical trial safety, product safety and risk management plans. May also carry responsibility for routine and ad hoc 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.

Qualifications:

  • Medical Doctorate (M.D.) degree or equivalent (D.O. or non-US equivalent of M.D). Relevant therapeutic specialty in an academic or hospital environment preferred. Completion of residency and/or fellowship is preferred.
  • Minimum of 2 years of clinical trial or medical affairs experience in the pharmaceutical industry or academia or equivalent. 3+ years of experience is preferred.
  • Knowledge of clinical trial methodology, data analysis and interpretation, regulatory requirements governing clinical trials and experience in development strategy and the design of protocols.
  • Ability to run a clinical study independently with little supervision.
  • Proven leadership skills in a cross-functional global team environment.
  • Ability to interact externally and internally to support global business strategy.
  • Must possess excellent oral and written English communication skills.

Additional Information:

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVie's policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because 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, status as a protected veteran, or any other legally protected group status.

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