30 jul
|
Skills Alliance
|
Madrid
30 jul
Skills Alliance
Madrid
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.
What You'll Do Clinical Strategy & Leadership
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
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
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
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
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
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 program and portfolio level
Strong grasp of general 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
📌 Vice President Clinical Operations - Ophthalmology (Madrid)
🏢 Skills Alliance
📍 Madrid