Unknown Company

Senior Clinical Research Director

morristown, nj • Posted 2 weeks ago
Onsite Full Time Bio & Pharmacology & Health

Main Responsibilities:

  • Serve as senior medical/scientific leader for Rheumatology/Transplant clinical programs.
  • Mentor CRDs and Clinical Scientists; build consensus and coordinate action plans to resolve study issues.
  • Anticipate issues by sharing lessons learned; raise study/project-level issues to TA Heads.
  • Collaborate cross-functionally to align operations (e.g., harmonize documents, endpoints, protocols).
  • Interact with Global Project Head, PV, Regulatory, and other key functional representatives.
  • Provide medical expertise to clinical studies/registries (incl. protocol development, Key Results, Clinical Study Reports).
  • Support pressure testing/cluster feasibility, medical review/validation of data, and study risk assessment.
  • Contribute to clinical portions of submission dossiers (CTD for FDA/EMA; filings for Japan/China; responses to health authority questions).
  • Provide medical input/training, feasibility assessments, medical review, and medical information to study teams/investigators.
  • Act as medical reference for clinical study team to ensure medical relevance and integrity of data.

Qualifications:

  • MD or equivalent medical degree required (DO, MBBS).
  • Training/experience in rheumatology, hematology, transplant, or immunology.
  • 4+ years in pharmaceutical industry (late-stage clinical development preferred).
  • Fluency in spoken and written English.

Skills/Competencies:

  • Strong scientific/medical expertise and clinical development methodology/design.
  • Excellent communication; risk-management mindset; ability to negotiate resources.
  • Teaching ability; matrix collaboration; international/intercultural skills; adaptable to digital solutions.

Benefits (explicit):

  • High-quality healthcare, prevention/wellness programs, and at least 14 weeks’ gender-neutral parental leave.

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Senior Clinical Research Director in morristown at Unknown Company

This position is listed as full time and onsite.

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