Post Approval Lifecycle Management (PALM) Physician Fellow

Job Description:

The Post Approval Lifecycle Management (PALM) Physician Fellow is an associate member of the PALM Clinical and Medical Team assigned to a one-year term (may be extended to include a second year of fellowship) rotating through multiple functional groups within PALM within J&J Innovative Medicine.

The goal of the fellowship is to (1) develop leadership, clinical, and medical technical skills in drug development and life-cycle management and (2) gain an understanding of the role of a physician in a pharmaceutical company.

The fellow is assigned to Therapeutic Area Portfolio(s) and supports the Clinical and Compound Development Teams (CDTs) to maximize the value of the portfolio(s). The fellow will be a valuable colleague to work with the extended PALM community through rotations with the Clinical, Medical Safety, Medical Affairs and Regulatory Affairs teams.

The fellow will spend up to 70% of their time working with functional coordinators and rotation mentors during each of their 12-18-weeks functional rotations (except Regulatory rotation which will be a floating rotation during the year). In parallel, the fellow will divide the remaining time working on key assigned clinical projects/activities (20%), engaging in activities led by PALM Talent Development Team (5%), and establishing connectivity and network-building opportunities with JNJ stakeholders (5%).

At the end of the third rotation and in alignment with the fellowship supervisor, the fellow will indicate their desire and interest to apply for a second-year extension of fellowship with a focus on up to two functional areas (6-month rotation each). The goal of the extension would be to gain additional practical experience and to complete clinical/medical projects as needed. Rotation coordinators and fellowship supervisor will assess candidacy for second year based on business needs and fellow performance and will communicate accordingly to fellow in order to plan for next steps to ensure a smooth transition into second year fellowship or off-fellowship to a permanent employment.

The fellow will be based at our Titusville site (NJ, United States) and will be expected to comply with in person attendance in the office as per J&J company requirements.

Roles and responsibilities:

• Achieve an overall understanding of how PALM is structured/works and how it fits into the overall JNJ Innovative Medicine/OCMO organization.
• Complete the required compliance functional training as appropriate for an interim member of the PALM Clinical & Medical Team.
• Ensure a clear understanding of the overall goals and objectives of PALM’s organization.
• Clinical:
  • Contribute to the execution of projects across different phases of clinical development.
  • Provide active medical and scientific contribution to cross-functional clinical teams.
  • Support successful completion of clinical projects and deliverables that enable worldwide registrations for new indications.
  • Complete enhancements to the label and compliance with regulatory commitments for products in the market and in development.
  • Support innovative development projects to further enhance the value of our products and the PALM organization to JNJ and the patients we serve. Work with the Clinical, Medical Affairs and Medical Safety Leaders, project management leads and extended CDT and their internal/ external partners in the execution of specific tasks and projects related to clinical studies and other tactical strategic activities conducted for the support of the assigned portfolio.
• Work in concert with the Clinical Leaders on clinical trial concept and protocol development, execute clinical studies for new formulations, post-approval commitments, and new indications.
• Be actively involved in creation of Clinical Study Reports, publication of clinical research findings and presentations to relevant FDA, EMA, or other Health Authorities, advisory committees, and review meetings.
• Work with Medical Safety, Medical Affairs, Regulatory Affairs rotation coordinators and their functional teams to learn and get experience in multiple sub-functional areas of responsibility to broaden the fellow’s understanding of the role of a physician in the pharmaceutical industry in a late lifecycle stage of the portfolio of products.
• Participate in cross-functional teams for evaluation of new product ideas and related innovative technologies; review medical literature, medical and market access plans.
• Medical Safety
  • Participate and complete training in several areas of pharmacovigilance, which include the following: safety surveillance and signal evaluation; identification of new potential safety concerns; characterization of emerging and known product safety profiles; the design and implementation of risk minimization strategies.
  • Provide medical expertise in the evaluation of safety data from a variety of sources (interventional and noninterventional clinical studies, post-marketing data, literature reports, and other sources of safety data) as part of the overall pharmacovigilance surveillance process; this includes medical review of individual case safety reports and evaluation of aggregate safety data.
  • Gain understanding of Medical Safety Officer (MSO) activities. Ensure communication of potential new safety concerns and trends to the MSO and the Safety Management Team.
  • Support SMT activities such as the evaluation of safety issues to characterize any emerging or known product safety profiles, preparation of aggregate safety reports, such as Periodic Benefit Risk Evaluation Reports, ad-hoc regulatory reports, and interpretation of surveillance and product quality data.
• Medical Affairs:
  • Gain an understanding of the structure and function of the PALM Global Medical Affairs organization
  • Gain an understanding of core strategic Global Medical Affairs activities including evidence generation, evidence communication, internal knowledge transfer, thought leader engagement, pre-approval access, and patient safety.
  • Gain an understanding of MAF role in key partnerships (CDT, MAST/regional MAF leads).
  • Support GMAF activities including medical need assessments, publications, development of core medical affairs product strategies and core narratives, among others.
• Regulatory Affairs:
  • Gain an understanding of the structure and function of the Global Regulatory Affairs organization.
  • Gain an understanding of the essential role of regulatory affairs in the matrix management of pharmaceutical products.
  • Gain insight into regulatory strategy and decision-making and understand key aspects of regulatory affairs specific to each region.
• Perform related duties as assigned by supervisor.
• Maintain compliance with all company policies and procedures.