Scientific Director / Medical Director, Pipeline Medical Strategy – Psychiatry

Role Summary

The Director, Medical Affairs + Health Impact (MHI) is a key scientific expert within the Pipeline Psychiatry Therapeutic Area. The position supports the development and execution of the Pipeline Psychiatry medical strategy by leading execution of strategic, insight, and educational initiatives in psychiatry. The Director provides expert-level scientific, strategic and operational input into core MHI activities and cross-functional strategic teams including evidence, insight, thought leader engagement plans, and clinical trial site interactions; generation and dissemination of clinical and scientific data; provider and payer educational initiatives. This position can be based from Mettawa, IL or Florham Park, NJ or Cambridge, MA location.

Responsibilities

• Collaborates with Pipeline Medical Strategy team to contribute to scientific strategy for pipeline psychiatry assets, including asset, education, and evidence strategies
• Develops and leads the execution of medical education tactics, advisory boards, and thought leader engagement plan in line with psychiatry pipeline strategic plan.
• Leads conference planning and execution
• Oversee clinical trial site identification, engagement, and education initiatives
• Provides subject matter expertise for MSL, health outcomes and commercial teams including competitive assessments and regular scientific literature reviews.
• Oversees development of early Scientific Communication Platforms and ensures alignment of all tactical initiatives
• Responsible for managing budget for assigned projects including consulting and vendor management.

Qualifications

• Required: Scientific degree (bachelor’s); MD, PhD, PharmD and/or other advanced scientific degree strongly preferred; board certified specialty qualification or equivalent and pharmaceutical industry recognized qualification (e.g., MSc) are desirable
• Required: 5-7+ years of prior biopharmaceutical/medical device industry experience, including substantial understanding of relevant therapeutic area
• Required: Prior Medical Affairs experience

Skills

• Should have a good understanding of legal and regulatory guidelines (OPDP promotional regulations, CDER/CBER regulations as they relate to drug approvals)
• Good understanding of Good Clinical Practices, ICH guidelines, PhRMA code, FDA CFR, ISO, clinical research ethics, HIPAA and patient privacy laws, EU Directive and other applicable local regulations
• Good understanding of Medical Affairs principles, study design and publications
• Knowledge of clinical trial methodology, regulatory requirements governing clinical trials and experience in the design of protocols
• Ability to gain cooperation of others and present technical information
• Represents AbbVie at external meetings including investigator meetings and scientific association meetings
• Ability to work effectively in a team/matrix environment