Senior Director, Clinical Development, Immunology

Johnson & Johnson   •  

Spring House, PA

Industry: Biotech/Pharma

  •  

5 - 7 years

Posted 294 days ago

This job is no longer available.

Responsibilities for the Senior Director include overall program leadership:

  • Designing of Clinical development program (CDP), as well as execution and reporting of trials
  • Monitoring safety of clinical trials and providing scientific leadership in the area of responsibility
  • Providing scientific & clinical leadership of Phase 2 and 3 clinical trial teams
  • Leading the development of the Integrated Study Plans and study summaries, IND submissions, and technical reports
  • Providing input to strategic decisions regarding therapeutic indications
  • Overseeing the preparation of clinical portions of Immunology project INDs, IBs, CTAs, BLAs and other regulatory submissions
  • Authorship of abstracts and manuscripts for publication based on clinical trial data
  • Presenting data and scientific information to the organization at all levels
  • Building credible relationships with opinion leaders and external alliances for partnered products when relevant
  • Line management accountability for promotions, recruitment strategy and team structure
  • May evaluate in-licensing opportunities and contribute to early development programs

Qualifications

Qualifications for the Senior Director include:

  • Requires an MD or doctorate level degree (e.g. PhD or PharmD)
  • Board certification in a relevant therapeutic area (Rheumatology) is highly desired
  • For non-MD candidates, experience in Rheumatology clinical development is highly desired
  • A minimum of 5 years of clinical research or clinical trials experience preferably in an industry setting is strongly preferred
  • Must have strong planning and communication skills to manage and proactively identify resource issues
  • Experience in clinical trial design and medical monitoring is highly desired.
  • Prior experience in a leadership role is a must.
  • This position may require up to 10% annual travel (domestic and international).

Requisition ID: 7855161004