ppWe'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. /p h3What You'll Do /h3 h3Clinical Strategy Leadership /h3 ul liOwn the clinical development strategy across our portfolio, aligned with corporate goals /li liLead and evolve Clinical Development Plans across programs and indications /li liGuide pipeline progression through all stages of development /li liMentor Senior Directors and Clinical Leads, ensuring consistent scientific and medical decision‑making /li /ul h3Program Oversight /h3 ul liProvide strategic oversight of trial execution, working closely with Clinical Operations /li liKeep programs on track for timelines, quality, and budget /li liHelp guide CRO performance and vendor strategy /li liAnticipate risks and steer mitigation at the program and portfolio level /li /ul h3Data Safety /h3 ul liLead interpretation of efficacy and safety data to inform program decisions /li liOversee safety strategy and governance, including escalation and benefit‑risk assessments /li liContribute to Data Monitoring Committees and internal safety reviews /li liDrive data‑based recommendations on program continuation, modification, or termination /li /ul h3Regulatory Documentation /h3 ul liProvide clinical leadership on regulatory strategy alongside Regulatory Affairs /li liReview key regulatory filings (INDs, CTAs/IMPDs, NDAs, MAAs, Annual Reports) /li liRepresent Clinical Development in interactions with health authorities (FDA, EMA, and others) /li liServe as a senior clinical voice with investigators, KOLs, partners,



and collaborators /li liBuild relationships with academic centers and clinical experts in relevant therapy areas /li liPartner with Research, Preclinical, Biometrics, CMC, Medical Affairs, and Business Development /li liSupport due diligence, fundraising, and partnering discussions /li /ul h3Compliance Communication /h3 ul liEnsure all clinical activities meet GCP, SOPs, and regulatory standards /li liCommunicate clinical strategy and progress clearly to Executive Team and Board /li liRepresent the company at investigator meetings, advisory boards, and scientific forums /li liChampion scientific rigor and patient‑centered decision‑making /li /ul h3What You Bring /h3 ul liMD strongly preferred, with 7+ years in clinical development in pharma/biotech (or 10+ years without an MD) /li liSenior leadership experience running clinical development programs in a clinical‑stage biotech or similarly advanced environment /li liA track record of setting and executing clinical strategy at the program and portfolio level /li liStrong grasp of general drug development and regulatory frameworks (FDA, EMA), including leading Health Authority interactions /li liExperience interpreting complex clinical data to guide major development and investment decisions /li liBackground in ophthalmology; experience in gene therapy, rare disease, or other advanced therapeutic modalities is a strong plus /li liExperience in a similarly sized biotech is a plus /li liProven ability to lead cross‑functional teams spanning Clinical Operations, Regulatory Affairs, Biometrics, and Translational Medicine /li liExperience managing and developing senior clinical leaders /li liStrong strategic and problem‑solving skills in a fast‑paced environment /li liExcellent communication skills, comfortable presenting to Executive Leadership, Boards, and external stakeholders /li liHigh ethical standards and a commitment to patient safety /li liFull professional proficiency in English /li /ul /p #J-18808-Ljbffr

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