Initiates medical affairs activities including data generation and dissemination strategy, development of Global Medical Affairs strategy, delivering the Medical Functional Plan, Brand Plan and working with Area and Affiliates to ensure execution of strategy.
Responsible from Medical Affairs for the design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study Reports, and Regulatory Submissions and responses.
M.D.s may participate in design and execution of clinical trial safety; scientifically accountable for resolution of safety issues, safety monitoring, and other scientific reports reported to regulatory authorities. Review and assess all Adverse Events (AE's) and Serious Adverse Events (SAE's).
Ensures budgets, timelines, compliance requirements are factored into programs' scientific activities.
Responsible for understanding regulatory requirements related to clinical studies and global drug development and accountable for complying with those requirements.
Experience Requirements
Position will be commensurate with experience.
Scientific Director
Advanced Degree PhD or PharmD. Additional post doctorate experience highly preferred.
Typically, 10-15 years of experience in the pharmaceutical industry or related.
7-10 years of experience in Medical Affairs with Global Medical Affairs experience highly preferred.
Senior Medical Director
Medical Doctorate (M.D.) 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 preferred.
Minimum 2 years of clinical trial or medical affairs experience in the pharmaceutical industry or academia or equivalent. 5 years of experience is preferred.
Requirements
Substantial understanding of relevant therapeutic area required. Direct subject matter expertise in multiple myeloma highly 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.
Proven leadership skills in cross-functional global team environment
Ability to interact externally and internally to support global
Benefits
Health insurance
Additional Information
The Scientific Director / Senior Medical Director provides specialist medical and scientific input into core strategic and operational medical affairs activities such as: health-care professional and provider interactions; generation of clinical and scientific data (enhancing therapeutic benefit and value); educational initiatives (medical education, scientific communications, and value proposition) and safeguarding patient safety (risk minimization activities and safety surveillance activities). Works closely with sales, marketing, and commercial teams to provide strategic medical input into core brand (product) strategies, and to support medical affairs, marketing activities (promotional material generation and product launches) and market access.
This position is ideally based from our Mettawa, IL or Florham Park, NJ sites but other U.S. sites may be considered. Must follow a hybrid schedule of 3 days/week onsite.
Abbvie · San Francisco, CA