- In cooperation with affiliate / Area Medical teams, Marketing, RA, Clinical and other functional areas, provides leadership, oversight and support for assigned products/projects.
- Establishes and approves scientific methods for hypotheses, rational, design of affiliate/Area/Global protocols and their reports.
- 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.
- 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. NB: 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. Initiates medical affairs activities and generation and dissemination of data supporting overall product scientific and business strategy.
- Provide scientific/medical education to investigators, clinical monitors, and Global Project Team members related to therapeutic area or disease specific information. Keeps a breast 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
- May act as medical/scientific leader for projects within an area or across several areaAssists 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 sub teams responsible for discrete projects within the therapeutic area (individual publications or study collaborations)
- Initiate research projects and drive them to completion, resulting in high quality publications. Ensures budgets, timelines, compliance requirements are factored into programs' scientific activities
- 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.
- 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.
- Ability to interact externally and internally to support global business strategy. Must possess excellent oral and written English communication skills.
- For clusters of countries multi-lingual skills of language is preferred.
Travel: Yes, 25 % of the Time
Job Type: Experienced