Senior Director of Clinical Innovation

4 days ago

Hosūr, Tamil Nadu, India beBeeClinical Full time ₹ 45,00,000 - ₹ 55,00,000
Clinical Leadership Opportunity

We are seeking an experienced Vice President to lead our global clinical strategy and development for novel biopharmaceuticals and complex biosimilars.

  • 15+ years of experience in clinical development, including 5+ years in leadership roles at biopharmaceutical companies.
  • Prior experience with global NDA/MAA submissions (FDA/EMA) for biologics/biosimilars is required.
About the Role

Clinical Strategy & Development Planning:

  1. Design global clinical development strategies for preclinical/clinical assets, aligning with regulatory and commercial objectives.
  2. Lead protocol development for pivotal trials, ensuring robust study designs to meet US FDA, EMA, and ICH guidelines.
  3. Collaborate with executive leadership to ensure integrated planning and cross-functional alignment.
  4. Identify opportunities for innovation in trial design, biomarkers, or patient recruitment strategies.
Responsibilities

Serve as primary liaison with global health authorities, preparing INDs, NDAs, and MAAs. Lead pre-submission meetings and address queries.

  • Oversee responses to regulatory inspections and audits, ensuring compliance with GCP, 21 CFR part 11, and ICH E6(R3).
  • Collaborate with data science and biostatistics teams to define endpoints, statistical analysis plans, and data strategy.
  • Guide the use of predictive analytics and machine learning in trial optimization.
Requirements

MD in Pharmacology/Medicine or related field; board certification preferred.

  • Experience: 15+ years in clinical development, including 5+ years in leadership roles at biopharmaceutical companies.
  • Proven success in global NDA/MAA submissions (FDA/EMA) for biologics/biosimilars.
  • Expertise in ophthalmology, metabolic disorders, or maternal-fetal therapeutics.

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