A two-year rotational leader development program for physicians to gain experience in 5 different areas: Clinical Pharmacology, Medical Affairs,Clinical 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.
- 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.
- 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.
- 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.
- 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.
- Responsible for understanding the regulatory requirements related to the clinical studies and accountable for complying with those requirements.
- 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 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 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.
- 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.
Qualification & Experience:
- Experience publishing research
- Demonstrated leadership skills
- Medical Doctor (M.D.), Doctor of Osteopathic Medicine (D.O.) or international equivalent medical degree that meets U.S. certification standards
- Medical specialty training in any of the following or related therapeutic areas: Dermatology
- U.S. Citizen or Permanent Resident
- Strong verbal/written communication skills
- Completion of U.S. residency training
- Fellowship training, associated with clinical research
- Effective presentations skills
- Demonstrates critical thought processes and analytical skills
- U.S. board eligibility or certification (U.S. State or Commonwealth licensure
- Additional healthcare/research academic degrees, including PhD or MPH
- A commitment to pursuing a career in clinical research
Vacancy Type: Full Time
Job Location: Chicago, IL, US
Application Deadline: N/A