Senior Medical Director

This is a fully remote position, open to applicants in Spain, +5 more countries.

📋 Description

• Serve as the medical monitor for designated oncology studies.

• Offer medical review related to protocols, provide guidance on eligibility and dose modifications, and contribute medical insights during data review meetings.

• Oversee medical aspects and act as the escalation contact for oncology studies within the assigned portfolio.

• Provide advice regarding study design and measurement criteria in clinical trials.

• Evaluate safety sections of study protocols and Investigator’s Brochures.

• Analyze safety listings, adverse events, laboratory data, vital signs, and ECG results.

• Review clinical trial reports from a safety standpoint.

• Evaluate adverse events and serious adverse events.

• Conduct senior medical evaluations of individual safety cases, cumulative case listings, PSURs, PBRERs, DSURs, and Risk Management Plans.

• Offer medical insights for regulatory documentation.

• Perform literature reviews and signal detection initiatives.

• Contribute to the development of departmental SOPs and tools.

• Train and mentor new Medical Advisors and Medical Directors.

• Act as a senior scientific authority in targeted oncology and hematology areas.

• Represent the organization at scientific and industry conferences, presentations, panels, and advisory boards.

• Contribute to publications, congress abstracts, white papers, and articles.

• Provide medical evaluations for oncology communication materials.

• Establish and maintain connections with KOLs and investigators.

• Monitor competitive landscapes, emerging standards of care, and trends in sponsor development pipelines.

• Collaborate with Business Development on bid strategies, proposals, bid defense meetings, and sponsor discussions.

• Deliver medical and scientific rationales for study designs, feasibility, and delivery strategies.

• Cultivate sponsor relationships and contribute to oncology therapeutic area strategies and service offerings.

⛳️ Requirements

• Medical degree (MD).

• Specialist medical training.

• Minimum of 10 years of post-qualification medical experience.

• At least 7 years of experience in oncology/hematology clinical development.

• Significant experience in a Medical Director role or equivalent position in a CRO, biotechnology, or pharmaceutical company.

• Practical experience as a medical monitor in oncology clinical trials, including the review of emerging safety data and medically-based decision-making during study execution.

• Experience as a member of safety data review boards in clinical trials or similar experience.

• Knowledge of Good Clinical Practice regulations, International Council for Harmonisation (ICH) guidelines, Pharmacovigilance legislation, and internal Standard Operating Procedures.

• Exceptional written and verbal communication skills.

• Capability to thrive in a fast-paced environment with shifting priorities.

• Willingness to travel internationally for sponsor meetings and scientific events.

• Experience in sponsor-facing scientific roles within a CRO, pharmaceutical, or biotechnology context (desirable).

• Ability to convey scientific depth into a clear and credible message in sponsor-facing environments (desirable).

• Established external scientific reputation in oncology, such as publications, congress presentations, advisory board participation, or a strong Key Opinion Leader network (desirable).

🏝️ Benefits

• Competitive compensation package.

• Comprehensive benefits.

• Opportunities for personal and professional growth.

• Collaborative and innovative work environment.

• Chance to make a significant impact in patients’ lives.

• Opportunities for international travel for sponsor meetings and scientific events.