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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.

Scientific/Medical Director, Global Medical Affairs - Migraine

Lake Forest, Illinois Req ID 2209261 Category Research and Development Division AbbVie

The Scientific Director/Medical Director manages the design and implementation of one or more clinical development programs in support of an overall Product Development Plan, based on strong medical and scientific principles, knowledge of compliance and regulatory requirements, AbbVie’s customers, markets, business operations and emerging issues. Oversees project-related education of investigators, study site personnel and AbbVie study staff.

Primary responsibilities include:

  • 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. Along with Clinical Operations, is responsible for oversight of study enrollment and overall timelines for key deliverables.
  • Responsible for design, analysis, interpretation and reporting of scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses and other program documents.
  • May oversee the work of Associate or Assistant Scientific Directors and of Clinical Scientists working on the same or related programs.
  • Provides in-house clinical expertise for the molecule and disease, coordinating appropriate scientific activities with internal stakeholders as they relate to ongoing clinical projects. May participate in due diligence or other business development activity. As required by program needs, contributes in partnership with Discovery colleagues to design and implementation of translational strategies.
  • May serve on a Clinical Strategy Team (CST), with responsibility for development of a rigorous, cross-functionally-aligned, vetted Clinical Development Plan with full consideration of contingencies and alternative approaches.
  • Acts as a clinical interface and actively solicits opinion leader interactions related to the molecule and disease area; partners with Medical Affairs, Commercial and other functions in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into Clinical Development Plans and protocols as appropriate.
  • Stays abreast of professional information and technology through conferences, medical literature and other available training, to augment expertise in the therapeutic area.
  • Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. Serves as a clinical representative for key regulatory discussions.
  • Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research.

For a Scientific Director title, the following is required:

  • An advanced degree is (PhD, PharmD, Medical Doctorate (M.D.) degree or (D.O. or non-US equivalent of M.D. meet requirements) is required
  • Ability to provide input and direction to clinical research with appropriate supervision.
  • At least 8 years of clinical trial experience in the pharmaceutical industry, academia, or equivalent.
  • Ability to oversee a clinical research program of moderate complexity with minimal supervision.
  • Ability to perform and bring out the best in others on a cross-functional global team.
  • Ability to interact externally and internally to support a global scientific and business strategy.
  • Knowledge of clinical trial methodology, regulatory and compliance requirements governing clinical trials and experience in development of clinical strategy and the design of study protocols.
  • Must possess excellent oral and written English communication skills.

For a Medical Director title, the following is required:

  • 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) is strongly 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.
  • 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 clinical study or medical affairs team independently with little supervision.
  • 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 possess excellent oral and written English communication skills.
  • Typically does not supervise employees but must be able to influence in a matrixed environment. Works mostly independently with limited guidance.
  • Ex-Us: At least one further major international language is preferred.
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)Keyboard use (greater or equal to 50% of the workday)
Travel: Yes, 20 % of the Time
Job Type: Experienced
Schedule: Full-time
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