What are the responsibilities and job description for the VP/SVP Head of Clinical Development position at BioSpace?
Description
Position Summary
The VP/SVP, Head of Clinical Development provides strategic, scientific/medical, and operational leadership across Ocugen’s clinical development programs. This individual will lead the design, execution, and oversight of clinical development strategies supporting ophthalmology and gene therapy programs from early-stage development through late-stage clinical trials and regulatory submissions, including IND and BLA-enabling activities.
The role requires a collaborative and hands-on clinical development leader capable of operating effectively within a fast-paced biotechnology environment. The successful candidate will partner cross-functionally with Clinical Operations, Regulatory Affairs, Medical Affairs, Quality, R&D and executive leadership to advance corporate development priorities and clinical milestones.
Responsibilities
Clinical Development Execution & Strategy
This position operates in an office setting, in person. Job may additionally require incumbent to be available outside of these hours to handle priority business needs.
Ocugen is an equal opportunity employer. In order to provide equal employment and advancement opportunities to all individuals, we make all of our employment decisions based upon merit, qualifications, abilities, and an individual’s conduct and performance. We will not make any of our decisions, and will not discriminate against any employee or applicant, on the basis of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including sexual orientation, gender identity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past, current or prospective service in the uniformed services, genetic information, or any other characteristic protected from discrimination under the law. Ocugen complies with applicable federal, state and local laws governing nondiscrimination in employment.
Position Summary
The VP/SVP, Head of Clinical Development provides strategic, scientific/medical, and operational leadership across Ocugen’s clinical development programs. This individual will lead the design, execution, and oversight of clinical development strategies supporting ophthalmology and gene therapy programs from early-stage development through late-stage clinical trials and regulatory submissions, including IND and BLA-enabling activities.
The role requires a collaborative and hands-on clinical development leader capable of operating effectively within a fast-paced biotechnology environment. The successful candidate will partner cross-functionally with Clinical Operations, Regulatory Affairs, Medical Affairs, Quality, R&D and executive leadership to advance corporate development priorities and clinical milestones.
Responsibilities
Clinical Development Execution & Strategy
- Lead integrated clinical development strategies aligned with corporate, scientific, and regulatory objectives
- Develop and execute clinical development plans supporting programs from early-stage development through Phase 3 trials and regulatory submissions
- Drive clinical positioning, protocol strategy, endpoint selection, patient population strategy, and overall development planning
- Translate scientific, medical, and clinical insights into actionable development plans and execution strategies
- Provide scientific and medical leadership for the design and execution of clinical studies, including protocol development and study strategy
- Oversee clinical trial conduct to ensure execution according to protocol, timelines, budget, quality standards, and regulatory requirements
- Monitor program progress, clinical data trends, safety findings, and emerging risks to support timely decision-making
- Partner closely with Clinical Operations and Biometrics to ensure effective study execution and data quality
- Oversee analysis and interpretation of clinical trial data to inform development strategy and regulatory decision-making
- Lead preparation of clinical summaries, presentations, publications, and scientific communications
- Present clinical development updates and data to executive leadership, Board members, investigators, partners, and external stakeholders
- Build and maintain strong relationships with key opinion leaders, investigators, scientific advisors, CROs, and clinical research sites
- Lead clinical advisory boards and scientific discussions supporting development strategy
- Represent Ocugen at scientific meetings, conferences, and industry engagements
- Partner closely with Research, Regulatory Affairs, Clinical Operations, Biometrics, Medical Affairs, Quality, Manufacturing, and Program Management teams to ensure integrated program execution
- Support strategic planning, portfolio prioritization, and evaluation of external collaborations or licensing opportunities
- Provide medical and clinical development input supporting translational and preclinical research activities
- Lead, mentor, and develop members of the clinical development organization
- Foster a collaborative, accountable, science-driven, and execution-focused environment
- Support recruitment, development, and retention of high-performing clinical personnel
- MD or DO required; Board Certification in Ophthalmology strongly preferred
- Additional advanced scientific degree preferred
- Minimum 7-10 years of biotechnology and/or pharmaceutical industry experience in clinical development leadership roles
- Significant ophthalmology clinical development experience required, including retinal disease and advanced ophthalmic therapeutics
- Experience with gene therapy, biologics, rare disease, or advanced therapeutic development strongly preferred
- Demonstrated experience leading programs across multiple phases of clinical development, including late-stage and BLA-enabling studies
- Deep knowledge of ophthalmology clinical trial design, FDA regulatory expectations, ICH-GCP guidelines, clinical endpoints, and safety oversight
- Prior experience supporting FDA interactions and preparing clinical components of regulatory submissions
- Strong understanding of clinical data analysis, interpretation, and benefit-risk assessment
- Proven ability to operate effectively within a small to mid-sized biotechnology company requiring both strategic leadership and hands-on execution
- Strong communication, executive presence, and cross-functional leadership capabilities
- Demonstrated success leading within matrixed and highly collaborative environments
This position operates in an office setting, in person. Job may additionally require incumbent to be available outside of these hours to handle priority business needs.
Ocugen is an equal opportunity employer. In order to provide equal employment and advancement opportunities to all individuals, we make all of our employment decisions based upon merit, qualifications, abilities, and an individual’s conduct and performance. We will not make any of our decisions, and will not discriminate against any employee or applicant, on the basis of race, color, religion, creed, national origin or ancestry, ethnicity, sex (including pregnancy), gender (including sexual orientation, gender identity and status as a transgender or transsexual individual), age, physical or mental disability, citizenship, past, current or prospective service in the uniformed services, genetic information, or any other characteristic protected from discrimination under the law. Ocugen complies with applicable federal, state and local laws governing nondiscrimination in employment.