A two-year rotational leader development program for physicians to gain experience in 5 different areas: Clinical Pharmacology, Medical Affairs, Pharmaceutical Development, Regulatory Affairs and Pharmacovigilance and Patient Safety. With supervision, participates in cross-functional teams to generate, deliver, and interpret high-quality clinical data supporting overall product scientific and business strategy. Provides scientific and technical support for assigned products; delivers scientific presentations; develops and maintains professional and credible relationships with key opinion leaders.
Key Responsibilities Includes :
With appropriate supervision, manages the design and implementation of study protocols for a development program in support of the 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.
Has responsibility for oversight of clinical studies, monitoring overall study integrity, 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.
Participation in design and execution of clinical trial safety, product safety and risk management plans. Responsible for routine and adhoc 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.
Contributes to design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses, and other program documents.
May interact with and coordinate appropriate scientific and medical activities with internal stakeholders (i.e. commercial, clinical operations, discovery, statistics, regulatory, etc…) as they relate to ongoing medical affairs projects. May assist as consultant/liaison with other corporations when working under licensing agreements and/or in the evaluation of new business development opportunities.
May assist in scientific/medical education of investigators, clinical monitors, and Asset Development 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.
Responsible for understanding the regulatory requirements related to the clinical studies and accountable for complying with those requirements.
May represent the medical function on cross-functional integrated teams for medical affairs activities. May represent AbbVie at external meetings including investigator meetings, scientific association meetings, etc.
May assist in the development of scientifically accurate marketing materials, medical education programs, advisories, and symposia. May assist with the scientific review, development, execution and communication of affiliate/area/global medical affairs sponsored or supported clinical research activities.
Exercises judgment within well-defined practices and policies. Typically does not supervise employees but must be able to influence in a matrixed environment. Works with some supervision and guidance.
Medical Doctor (M.D.), Doctor of Osteopathic Medicine (D.O.) or international equivalent medical degree that meets U.S. certification standards
Completion of U.S. residency training
U.S. board eligibility or certification (U.S. State or Commonwealth licensure
U.S. Citizen or Permanent Resident
Medical specialty training in any of the following or related therapeutic areas: Neurology
Fellowship training, associated with clinical research
Additional healthcare/research academic degrees, including PhD or MPH
A commitment to pursuing a career in clinical research
Experience publishing research
Demonstrated leadership skills
Strong verbal/written communication skills
Effective presentations skills
Demonstrates critical thought processes and analytical skills
Equal Opportunity Employer Minorities/Women/Veterans/Disabled