Senior Vice President

The Senior Vice President (SVP), Ophthalmology is a physician scientist, who will have responsibility for PYC's RP11 and ADOA programs, providing strategic direction on regulatory pathways, clinical trial design, operational excellence, interpretation of results, leading communication with investors and other external parties.

• 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.

Primary Duties & Responsibilities

• Define and execute the overall medical and clinical vision, ensuring the company answers high-impact clinical questions that drive value for patients, physicians, and stakeholders.
• Serve as the Sponsor's Responsible Medical Officer to provide expert medical guidance and oversight for all clinical activities for ophthalmic products and trials, including interactions with clinical site personnel and clinical study Medical Monitors to address medical and safety-related study topics.
• Provide pharmacovigilance oversight, responsible for supporting Clinical Operations in ensuring overall safety of the ophthalmic drug product and compliance with all relevant safety monitoring and reporting regulations, standards, and ethical guidelines, in collaboration with Pharmacovigilance / Medical / Safety colleagues.
• Support the Research & Development (R&D) team by providing medical input into the design of clinical research deliverables, such as Clinical Development Plan (CDP), Integrated Development Plan (IDP), Clinical Trial Protocols (CTP), and Clinical Study Reports (CSR), and contributing to/driving development of disease clinical standards for new ophthalmic disease areas.
• Function as the primary company liaison with Data Safety Monitoring Boards (DSMBs).
• May interface with Nonclinical / Translational Sciences to drive transition of pre-Proof of Concept projects to Development Decision Point, including target identification and due diligence together with other medical matters, as needed.
• Guide the development of the clinical validation studies to support regulatory approval, physician adoption, and payer reimbursement. Ensure that the company's clinical development aligns with FDA, EMA, and other global regulatory requirements to support product adoption and commercialization.
• Engage with regulators, Key Opinion Leaders (KOLs), investors, and strategic partners and represent the company at major conferences, advisory board meetings, and strategic industry and investor discussions to serve as the primary medical and scientific voice for PYC's ophthalmic division.

Education & Experience

• M.D. or equivalent medical degree is required in addition to advanced knowledge and clinical training in medical/scientific area; Clinical practice experience 5 years (including residency) and board certification or eligibility in ophthalmology.
• Minimum of 15 years of experience in clinical research or drug development in the pharmaceutical / biotechnology industry.
• Experience in an academic clinical research or industry environment spanning clinical activities in Phases I through IV required.
• Ten (10) years of contribution to and accomplishment in all aspects of conducting clinical trials (e.g., planning, executing, reporting and publishing) in a global/matrix environment in pharmaceutical industry required.
• Proven ability to interpret, discuss and present efficacy and safety data relating to clinical trial(s) and proven ability to understand and interpret basic and clinical scientific research reports.
• Demonstrated ability to establish effective scientific partnerships with key stakeholders.
• Working knowledge of GCP, clinical trial design, statistics, and regulatory and clinical development processes, including record of achievement in filing successful Investigational New Drug Applications (INDs) and/or New Drug Applications (NDAs), Biologics License Applications (BLAs), or equivalent.
• Experience working in fast-paced biotech environments is essential.

Skills & Competencies

• Understanding of global regulatory standards pertaining to clinical trials and regulatory governing bodies such as FDA, EMA, MHRA, PDMA, TGA, ICH etc.
• Deep experience in clinical development, particularly mid to late-stage pivotal studies. Successful track record in drafting and implementing clinical trial protocols.
• Working knowledge of medical/safety-related regulatory requirements and guidelines, including US FDA IND safety reporting requirements and US FDA post-marketing reporting of adverse drug experiences for marketed products. Knowledge of EU Good Pharmacovigilance Practices (GVP) is a plus.
• Strong understanding of clinical operations, pharmacovigilance, and biometrics.
• Exceptional interpersonal skills with proven ability to build and maintain effective relationships with key stakeholders in the healthcare industry.
• Substantial experience in project and team leadership.
• Desirable to have development of RNA therapies and experience contributing to commercial strategy development.

Additional Requirements

• This position is hybrid - primarily working remotely, but with occasional work onsite in the San Ramon, CA office (as needed), for in person meetings and interactions.
• Ability to travel up to 10% when required, domestic and/or global.

Salary and benefits

• The Salary range for this role is $300-550k 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.