Senior Clinical Research Director
$236,250–$393,750 year
On-siteCambridge, Massachusetts, United States or Morristown, New Jersey, United States
Job Summary
Lead the Rheumatology/Transplant clinical development team as a senior medical and scientific leader, driving breakthroughs in immunoscience through protocol development, medical review of data, and study risk assessment. Mentor Clinical Scientists, build consensus with stakeholders, and coordinate action plans to resolve project-related study issues. Collaborate cross-functionally with Global Project Heads, Regulatory, and key functional representatives to ensure aligned operational approaches and harmonized study documents. Provide medical expertise for clinical studies and registries, including protocol development, Key Results, and Clinical Study Reports, while contributing to submission dossiers for FDA, EMA, Japan, and China. Anticipate potential issues by sharing lessons learned across teams and raising study-level concerns to TA Heads as relevant.
Required Qualifications
- MD or equivalent medical degree (DO, MBBS)
- Medical training or clinical development experience in rheumatology, hematology, transplant, or immunology
- At least 4 years in the pharmaceutical industry
- Experience in late-stage clinical development
- English fluency (spoken and written)
- Location: Cambridge, MA
- US and Puerto Rico Residents Only
- North America Applicants Only
Desired Qualifications
- Understanding of pharmaceutical product development and life cycle management gained through approximately 4 years of clinical development and medical experience
- Excellent scientific and medical/clinical expertise
- Excellent expertise in clinical development methodology and design of clinical studies
- Excellent communication skills (verbal and written) for interactions across functional areas and with key regulatory agencies
- Demonstrated capability to challenge decisions and the status quo with a risk-management approach
- Ability to negotiate to ensure operational resources are available for continued clinical conduct
- Fluency in written and spoken English
- Excellent teaching skills with a demonstrated ability to assist and train others
- Ability to work effectively within a matrix model
- Strong international/intercultural working skills
- Open-minded and adaptable to new digital solutions
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