Head Of Clinical Development

Description

Description

Ocugen is a publicly traded biotech organization dedicated to discovering, developing, and commercializing cutting-edge gene and cell therapies, and biologics to transform global healthcare. If you're ready to be part of a team that's shaping the future of medicine and making a profound impact on patient lives worldwide, join Ocugen and we’ll rewrite the future of patient care together.

Job purpose

The Head of Clinical Development will provide strategic direction and technical leadership to the clinical development team, including clinical-regulatory development planning, clinical trial design, implementation and execution, clinical data analysis and management, and clinical competitive intelligence. This role is responsible for overseeing trials and pharmacovigilance according to established timelines, for establishing and maintaining close working relationships with internal and external partners, and for providing the clinical regulatory landscape for each of the clinical programs.

Duties and responsibilities

• Design and oversee execution of multi-layered clinical development strategies and planning.
• Oversee the direction of clinical trial execution and planning of clinical operations, including compliance with protocols, regulatory standards, and standard operating procedures.
• Manage drug safety and pharmacovigilance activities for ongoing trial(s).
• Manage Medical Affairs Team.
• Prepare clinical portions of IND submissions and BLAs, including protocols and protocol amendments, investigator brochures, drug safety update reports, clinical study reports, medical reports, efficacy and safety summaries, scientific rationales, and benefit/risk ratios.
• Ensure documentation and analysis of clinical data collection, including final report development in compliance with regulatory and medical standards.
• Rapidly integrate new insights from on-going clinical trials and translating science into development plans and clinical trial activities.
• Create compelling data presentations for external disclosures.
• Develop and maintain key opinion leader relationships and serve as the clinical lead for advisory meetings.
• Establish and maintain relationships with external companies such as investigators, and opinion leaders to optimize performance on clinical trial activities.
• Prepare manuscripts for technical journals and make presentations at scientific meetings.
• Support new and ongoing clinical research and clinical trials, ensuring efficient and timely processing of confidentiality and clinical agreements.
• Work collaboratively with Research to provide input into the design of preclinical studies to support drug products entering or in the clinic and by helping initiate IND submissions.
• Provide input to evaluate products for in-licensing/out-licensing.
• Participate in business development processes as needed.
• Provide clinical portions of regulatory documents such as Investigator Brochure updates and Drug Safety Update Reports.
• Train clinical research team members, evaluate their performance, and select, develop, and manage personnel to ensure the efficient operation of the function.
• Scientific Communication & Data Analysis
  • Data presentation
  • KOL committee Lead
  • Publications & abstracts
  • Conferences
  • Heading Journal Club
  • Imaging Center and comprehensive data analysis

Qualifications

Qualifications

• Required: MD, DO with clinical experience
• Preferred: A PhD in addition to the above
• 10 years of management experience in ophthalmology clinical development.
• Gene Therapy experience preferred
• Clinical residency training in ophthalmology
• Experience with retinal diseases
• 10 years of experience in ophthalmology clinical development in pharmaceutical/biotech industry, across multiple phases of clinical research (Phase 1-3)
• Knowledge of ICH-GCP and FDA regulatory guidelines