The Vice President (VP) of Global Clinical Operations is responsible for the strategic leadership, planning, and execution of global clinical trials across all phases of drug development. This role ensures high-quality, efficient, and regulatory-compliant execution of clinical programs to support regulatory approvals. The VP will lead a high-performing team and collaborate cross-functionally with key stakeholders, including regulatory, biostats, pharmacovigilance, and future medical affairs and commercial teams.
Primary Duties & Responsibilities
- Develop and drive the global clinical operations strategy to support the company's pipeline and corporate objectives.
- Oversee the design, execution, and management of all clinical trials (Phase 1-4), ensuring compliance with global regulatory requirements (FDA, EMA, MHRA, TGA, etc.).
- Establish and maintain key performance indicators (KPIs) to track the efficiency, cost, and quality of clinical trial execution.
- Lead and manage the global clinical operations team, including Heads of clinical operations of different regions, Clinical Trial Managers, Clinical Research Associates, and Clinical Project Leaders.
- Ensure operational excellence by optimizing trial timelines, budgets, and vendor partnerships (CROs, central labs, reading centers, data management, etc.).
- Implement risk-based monitoring and adaptive trial strategies to enhance efficiency and patient safety.
- Partner with Regulatory Affairs, Medical Affairs, and Biostatistics to ensure alignment between clinical development and regulatory strategies.
- Work closely with commercial teams to align trial designs with market access and reimbursement requirements.
- Ensure adherence to Good Clinical Practice (GCP), ICH guidelines, and all applicable global regulatory requirements.
- Lead inspection readiness efforts and provide oversight for regulatory submissions (IND, NDA/BLA, MAA).
- Represent Clinical Operations in regulatory agency meetings and advisory boards as needed.
Education & Experience
- Advanced degree (PharmD, MD, PhD or MS (RN) in Life Sciences) preferred.
- Proven leadership experience managing global clinical trials across multiple therapeutic areas (preferably Ophthalmology and Nephrology).
- Strong track record in late-phase clinical development and regulatory submissions.
- Experience working in fast-paced biotech environments is essential.
Skills & Competencies
- Deep knowledge of global clinical trial regulations, including FDA, MHRA, EMA, PMDA, and TGA requirements.
- Strong financial acumen with expertise in budget forecasting and cost control for clinical programs.
- Excellent leadership, communication, and stakeholder management skills.
Additional Requirements
- The strong preference is for this job to be in the San Francisco Bay area with hybrid work onsite in the San Ramon, CA office
- Ability to travel up to 10% when required, domestic and/or global.
Salary and benefits
- The Salary range for this role is $240-300k per annum plus bonus, depending on relevant experience.
- PYC offers a competitive benefits package to our eligible employees including competitive medical and dental insurance, equity incentive plan, 401(k) program with employer match and a generous holiday and PTO policy
About PYC
- PYC develops life-changing drugs for patients with major unmet medical needs.
- Each of PYC's 3 clinical-stage assets has the potential to become the standard of care in areas of high unmet patient need (markets worth $1-$10 billion per annum).
- Now is an incredibly exciting time to join PYC with high-value human data readouts expected across all three clinical trial programs throughout 2025 and 2026.
- PYC is an Australian listed company with ambitions to grow its senior leadership team and operations in the US. PYC has offices in San Francisco Bay Area (San Ramon) and Perth and Sydney, Australia.
Our Clinical Programs
- RP11 is a devastating, progressive and blinding eye disease caused by under-expression of the PRPF31 gene. Patients experience vision changes from childhood, leading to legal blindness by 40-50 years of age. Disease management consists of visual aids and genetic counselling, but there are currently no available treatments for RP11 that treat the course of the disease.
PYC has developed VP-001, a therapy that addresses the underlying genetic cause of RP11 and has achieved breakthrough pre-clinical results in the rescue of the appearance of affected retinal cells in patient-derived models. VP-001 is the first drug candidate to enter clinical trials for RP11 and is currently in a mid-stage clinical study in RP11 patients. VP-001 has provided promising safety and efficacy insights from RP11 patients dosed in this Phase 1 study. In 2025, PYC intends to commence a Phase 3 registrational study.
- ADOA is a debilitating, blinding eye disease caused by insufficient gene expression of the OPA1 gene in optic nerve cells of the eye. Patients experience progressive and irreversible vision loss, with many experiencing their first symptoms of vision loss before 10 years of age. There are no current treatments available for ADOA patients.
PYC has developed PYC-001, a potentially disease-modifying drug that is unique in its potential for full restoration of cell function. PYC-001 is currently in clinical studies in ADOA patients and is the first precision therapy to be dosed in patients with ADOA.
- ADPKD is a severe disease that causes cysts to form in a patient's kidneys, which can ultimately lead to kidney failure, dialysis and transplantation. ADPKD is caused by insufficient expression of the PKD1 gene in the renal tubular epithelial cells of the kidney. There are no available therapies for patients with ADPKD that address the underlying cause of the disease. ADPKD affects 1 in 1000 people.
PYC is currently conducting early-stage clinical trials with PYC-003, a treatment that could arrest the disease course of ADPKD and enable regeneration and restoration of kidney function.