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Osanni Bio · 1 day ago

VP, Clinical Development

San Francisco Bay Area

Full-time

Onsite

Director/Executive

$310K/yr - $350K/yr

15+ years exp

Osanni Bio is seeking a Vice President of Clinical Development to lead their clinical science strategy and shape the future of their development programs. This role involves defining and driving clinical development plans, providing scientific leadership, and ensuring the highest standards of scientific integrity, particularly in the field of ophthalmology.

Biotechnology

Responsibilities

Define and oversee the clinical development strategy for ophthalmic therapeutic programs, ensuring alignment with corporate objectives and regulatory requirements

Serve as the clinical science lead for all development programs, ensuring organizational alignment with clinical development plans, trial designs, and data interpretation

Represent the company at scientific and medical conferences, advisory boards, and key opinion leader (KOL) engagements

Lead the development of core clinical and regulatory documents, including protocols, investigator brochures, clinical study reports, protocol amendments, and submission-ready materials

Provide scientific leadership across all aspects of trial planning: feasibility assessments, operational strategy, safety oversight, and data-related processes

Partner cross-functionally with physicians, clinical operations, regulatory, nonclinical, CMC, and data science to ensure seamless execution of clinical programs

Develop and implement regulatory engagement strategies to support productive interactions with the FDA and global health authorities

Provide strategic direction and high-level oversight to ensure alignment with Clinical Operations regarding trial objectives and regulatory standards

Guide medical data review and ensure data quality, patient safety, and scientific integrity across studies

Interpret emerging clinical results and provide recommendations for ongoing and future development activities

Author and review clinical components of regulatory submissions (IND, CTA, NDA/BLA)

Support preparation of abstracts, manuscripts, and key internal and external program updates

Build and mentor a high-performing clinical development team focused on scientific excellence

Foster a culture of collaboration, innovation, and accountability across clinical functions

Qualification

Ophthalmology experienceClinical trial designClinical development experienceRegulatory submissionsBiostatistics knowledgeLeadership skillsStrategic thinkingProblem-solving skillsInterpersonal skillsCommunication skills

Required

Bachelor's degree in life sciences or related field; advanced Scientific and/or clinical degree or demonstrated mastery of scientific data required

15+ years of clinical development experience in biotech or pharma, including 5+ years in senior leadership

Ophthalmology experience is required

Experience in development-stage organization required

Proven success in designing and overseeing early-phase clinical trials, including OUS Phase 1/2 studies, and leading regulatory interactions

Strong knowledge of clinical trial design, data interpretation, biostatistics, and regulatory frameworks (FDA, EMA, ICH, GCP)

Experience drafting clinical sections of FDA submissions required

Ability to partner with retina imaging reading centers and manage clinical data processes

Demonstrated leadership in building and guiding cross-functional teams (clinical operations, data management, supply chain)

Strategic thinker with excellent problem-solving, organizational, and interpersonal skills

Outstanding communication skills and ability to engage internal and external stakeholders

Willingness to travel 20–25% for clinical and corporate activities

Preferred

Deep expertise in clinical research, clinical science, and ophthalmology; experience in retina/AMD and early-phase development (Phases 1–2) strongly preferred

San Francisco Bay Area location preferred