Development Scientific Director, I&I

Role Summary

Development Scientific Director, I&I at Morristown, NJ. Leading clinical development strategy and providing clinical-scientific expertise across R&D projects, collaborating with cross-functional teams, regulators, and external partners to deliver development plans and regulatory documentation.

Responsibilities

• Collaborate with medical and clinical experts to deliver development strategy and assist with regulatory interactions
• Provide clinical scientific expertise to conduct studies from early phases to lifecycle management programs
• Develop study-level regulatory documentation (Abbreviated Protocol, Protocol, Amended Protocol) and lead start-up activities (pressure tests, competitive intelligence, patient engagement, feasibility, risk assessment)
• Provide clinical input for activities related to study conduct (IRB/HA responses, training, data review, medical information, and investigators)
• Contribute to the clinical portion of regulatory submissions (CTD/healthy authority inquiries)
• Serve as scientific and medical reference for the Study team and ensure medical relevance of clinical data
• Lead start-up activities and ensure quality of clinical data through ongoing validation and safety/efficacy data review
• Lead study-specific committees and co-develop the SAP with Biostatistics
• Prepare key results and communicate study-related issues with corrective action plans
• Review regulatory and safety documents and participate in advisory committee preparations
• Author manuscripts/abstracts and collaborate with knowledge experts or advisory boards
• Evaluate medical literature and competitive status to inform development strategies

Qualifications

• Advanced degree (PhD in Life Science/Health Science; MPH or Biomedical Science master with extensive drug development experience may be considered)
• At least 3 years of experience in clinical development in pharma, CRO, or healthcare institution

Skills

• Strong understanding of pharmaceutical product development and lifecycle management
• Scientific and medical/clinical expertise with deep knowledge of clinical development methodology
• Excellent verbal and written communication across functions and with regulatory agencies
• Problem-solving capability and risk-management approach
• Negotiation skills to secure operational resources for clinical conduct
• English fluency; teaching and training ability; matrix-style collaboration; intercultural communication
• Open to applying new digital solutions

Education

• Advanced degree such as PhD in Life Science or Health Science; MPH or Biomedical Science master considered with extensive drug development experience