We're looking for a Vice President of Clinical Development to lead the clinical and medical strategy across our drug development pipeline. You'll drive Clinical Development Plans, oversee trial design and execution, and ensure everything we do meets GCP and regulatory standards. This is a senior leadership role with direct visibility to the Executive Team and Board, and regular interaction with regulators, investigators, and partners.

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What You'll Do
Clinical Strategy & Leadership

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- Own the clinical development strategy across our portfolio, aligned with corporate goals

- Lead and evolve Clinical Development Plans across programs and indications

- Guide pipeline progression through all stages of development

- Mentor Senior Directors and Clinical Leads, ensuring consistent scientific and medical decision‑making

Program Oversight

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- Provide strategic oversight of trial execution, working closely with Clinical Operations

- Keep programs on track for timelines, quality, and budget

- Help guide CRO performance and vendor strategy

- Anticipate risks and steer mitigation at the program and portfolio level

Data & Safety

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- Lead interpretation of efficacy and safety data to inform program decisions

- Oversee safety strategy and governance, including escalation and benefit‑risk assessments

- Contribute to Data Monitoring Committees and internal safety reviews

- Drive data‑based recommendations on program continuation, modification, or termination

Regulatory & Documentation

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- Provide clinical leadership on regulatory strategy alongside Regulatory Affairs

- Review key regulatory filings (INDs, CTAs/IMPDs, NDAs, MAAs, Annual Reports)

- Represent Clinical Development in interactions with health authorities (FDA, EMA, and others)





- Serve as a senior clinical voice with investigators, KOLs, partners, and collaborators

- Build relationships with academic centers and clinical experts in relevant therapy areas

- Partner with Research, Preclinical, Biometrics, CMC, Medical Affairs, and Business Development

- Support due diligence, fundraising, and partnering discussions

Compliance & Communication

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- Ensure all clinical activities meet GCP, SOPs, and regulatory standards

- Communicate clinical strategy and progress clearly to Executive Team and Board

- Represent the company at investigator meetings, advisory boards, and scientific forums

- Champion scientific rigor and patient‑centered decision‑making

What You Bring

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- MD strongly preferred, with 7+ years in clinical development in pharma/biotech (or 10+ years without an MD)

- Senior leadership experience running clinical development programs in a clinical‑stage biotech or similarly advanced environment

- A track record of setting and executing clinical strategy at the xqbhyrx program and portfolio level

- Strong grasp of integral drug development and regulatory frameworks (FDA, EMA), including leading Health Authority interactions

- Experience interpreting complex clinical data to guide major development and investment decisions

- Background in ophthalmology; experience in gene therapy, rare disease, or other advanced therapeutic modalities is a strong plus

- Experience in a similarly sized biotech is a plus

- Proven ability to lead cross‑functional teams spanning Clinical Operations, Regulatory Affairs, Biometrics, and Translational Medicine

- Experience managing and developing senior clinical leaders

- Strong strategic and problem‑solving skills in a fast‑paced environment

- Excellent communication skills, comfortable presenting to Executive Leadership, Boards, and external stakeholders

- High ethical standards and a commitment to patient safety

- Full professional proficiency in English

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📌 Vice President Clinical Operations - Ophthalmology (España)
🏢 Skills Alliance
📍 España