The Physicians Development Program develops and supports high-potential specialist physician talent in transitioning to a career in industry and in becoming well-rounded R&D physicians with the enterprise mindset sought in future R&D leaders. The PDP is a two-year rotational leadership development program with core rotations in Clinical Development and additional exposure and experience in Clinical Pharmacology, Regulatory Affairs, Pharmacovigilance and Patient Safety, and Medical Affairs. With supervision, each Physician Development Program member 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.
PDP members are based in Lake County, Illinois. PDP members who are oncologists may choose to be based in South San Francisco, California instead.
Key Responsibilities Include:
- 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 Development Operations, is responsible for oversight of study enrollment and overall timelines for key deliverables.
- Participates in the design and execution of clinical trial safety, product safety and risk management plans. Responsible 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.
- 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 assist in scientific/medical education of investigators, clinical monitors, and asset strategy 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. Assist in or review regulatory documentation/submissions.
- 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
- Medical specialty training in any of the following or related therapeutic areas: oncology, gastroenterology, rheumatology, dermatology, neurology
- Completion of U.S. residency training
- Fellowship training, associated with clinical research
- U.S. board eligibility or certification (U.S. State or Commonwealth licensure)
- U.S. Citizen or Permanent Resident
- 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
Key Leadership Competencies:
- Builds strong relationships with peers and cross-functionally with partners outside of team to enable higher performance
- Learns fast, grasps the "essence" and can change course quickly where indicated
- Raises the bar and is never satisfied with the status quo
- Creates a learning environment, open to suggestions and experimentation for improvement
- Embraces the ideas of others, nurtures innovation and manages innovation to reality
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel: Yes, 10 % of the Time
Job Type: Experienced