08 ago
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Skills Alliance
|
Madrid
08 ago
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 DoClinical Strategy & LeadershipOwn the clinical development strategy across our portfolio, aligned with corporate goalsLead and evolve Clinical Development Plans across programs and indicationsGuide pipeline progression through all stages of developmentMentor Senior Directors and Clinical Leads, ensuring consistent scientific and medical decision‑makingProgram OversightProvide strategic oversight of trial execution, working closely with Clinical OperationsKeep programs on track for timelines, quality, and budgetHelp guide CRO performance and vendor strategyAnticipate risks and steer mitigation at the program and portfolio levelData & SafetyLead interpretation of efficacy and safety data to inform program decisionsOversee safety strategy and governance, including escalation and benefit‑risk assessmentsContribute to Data Monitoring Committees and internal safety reviewsDrive data‑based recommendations on program continuation, modification, or terminationRegulatory & DocumentationProvide clinical leadership on regulatory strategy alongside Regulatory AffairsReview 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 collaboratorsBuild relationships with academic centers and clinical experts in relevant therapy areasPartner with Research, Preclinical, Biometrics, CMC, Medical Affairs, and Business DevelopmentSupport due diligence, fundraising, and partnering discussionsCompliance & CommunicationEnsure all clinical activities meet GCP, SOPs, and regulatory standardsCommunicate clinical strategy and progress clearly to Executive Team and BoardRepresent the company at investigator meetings, advisory boards, and scientific forumsChampion scientific rigor and patient‑centered decision‑makingWhat You BringMD 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 environmentA track record of setting and executing clinical strategy at the program and portfolio levelStrong grasp of integral drug development and regulatory frameworks (FDA, EMA), including leading Health Authority interactionsExperience interpreting complex clinical data to guide major development and investment decisionsBackground in ophthalmology;
experience in gene therapy, rare disease, or other advanced therapeutic modalities is a strong plusExperience in a similarly sized biotech is a plusProven ability to lead cross‑functional teams spanning Clinical Operations, Regulatory Affairs, Biometrics, and Translational MedicineExperience managing and developing senior clinical leadersStrong strategic and problem‑solving skills in a fast‑paced environmentExcellent communication skills, comfortable presenting to Executive Leadership, Boards, and external stakeholdersHigh ethical standards and a commitment to patient safetyFull professional proficiency in English
📌 Vice President Clinical Operations - Ophthalmology (Madrid)
🏢 Skills Alliance
📍 Madrid