Associate Director, Clinical Sciences

1 week ago

Raritan, New Jersey, United States Johnson & Johnson Full time
At Johnson & Johnson,?we believe health is everything.

Our strength in healthcare innovation empowers us to build a?world where complex diseases are prevented, treated, and cured,?where treatments are smarter and less invasive, and?solutions are personal.

Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

Learn more at

Johnson & Johnson is recruiting for an Associate Director, Clinical Project Scientist - Ophthalmology to be located in Raritan, NJ, Spring House, PA, Cambridge, MA, or La Jolla, CA .

Remote work options may be considered on a case-by-case basis and if approved by the Company.

The Associate Director, Clinical Project Scientist is a responsible member of a clinical team dedicated to the development and execution of clinical strategies and the clinical and operational implementation of a complex compound program.

The Associate Director, Clinical Project Scientist provides active scientific contribution to a cross-functional clinical team developing a molecular entity.

The Associate Director, Clinical Project Scientist provides input to the clinical development plan, works on the development of the clinical trial protocol, clinical trial materials, and takes responsibility for coordinating completion of clinical study reports and supports preparation of relevant documents for regulatory filings.

This role involves extensive team matrix interactions with colleagues from several different disciplines.

The Associate Director, Clinical Project Scientist may be asked to contribute to the evaluation of scientific opportunities in the therapeutic area.


ESSENTIAL FUNCTIONS:

  • Leads/Supports preparation of clinical development plans, trial protocols, and supports the operations group with trial set up and monitoring and authoring of clinical study reports.
  • Assists Physicians in evaluation of adverse events (pre and post-marketing) for relationship to treatment and supports the interpretation and reporting of results.
  • Assists Regulatory Affairs in determining requirements for any corrective actions or health authority reporting.
  • Interprets, reports, and prepares oral and written results of product research, in concert with senior clinical personnel, in preparation for health authority submissions.
  • Responsible for clinical data review, including medical data review, coding, in conjunction with other clinical team members.

OTHER RESPONSIBILITIES / DETAILED DUTIES:

  • Assists Regulatory Affairs in the development of drug regulatory strategies.
  • Participate on and may lead cross-functional teams for evaluation of new product ideas, implement franchise business strategies, etc.
  • Reviews medical literature and related new technologies
  • May be asked to lead the execution of contracts.
  • May be asked to assess medical publications emerging from the team and its affiliates.
  • May be responsible, with appropriate colleagues, for review of Company advertising and promotion.
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