[Hiring] Senior Medical Director @TFS HealthScience

Role Description

As part of our CDS Hematology & Oncology team, you will be working alongside passionate and innovative professionals to ensure our customers achieve their goals. The Senior Medical Director is the most senior medical role in the oncology therapeutic area, combining hands-on medical monitoring and portfolio-level medical oversight with responsibility for scientific credibility and visibility with current and future sponsors.

Key Responsibilities:

• Acts as medical monitor for assigned oncology studies, including protocol-related medical review, eligibility and dose-modification queries, ongoing review of emerging safety data, and medical input to data review meetings.
• Provides medical oversight of, and acts as the escalation point for, oncology studies in delivery across the assigned portfolio.
• Provides advanced medical advice on study design and measurements in clinical trials.
• Reviews the safety sections of study protocols and of the Investigator’s Brochure.
• Reviews safety listings, including adverse events, laboratory listings, vital signs, and electrocardiogram (ECG) data.
• Reviews clinical trial reports from a safety perspective.
• Performs medical assessment of adverse events (AEs) and serious adverse events (SAEs).
• Performs senior level medical review of individual safety cases, cumulative case listings, Periodic Safety Update Reports (PSURs), Periodic Benefit-Risk Evaluation Reports (PBRERs), Development Safety Update Reports (DSURs), and Risk Management Plans.
• Provides medical input to regulatory documents.
• Carries out literature review and signal detection activities.
• Contributes to departmental Standard Operating Procedures (SOPs) and tools.
• Provides education and supervision of new Medical Advisors and Medical Directors.

Scientific credibility and thought leadership:

• Acts as a senior scientific voice of the company in the targeted indications, building credibility with current and future sponsors.
• Represents the company at scientific and industry meetings, including presentations, panel participation, and advisory boards, according to an agreed annual plan.
• Contributes thought leadership content such as publications, congress abstracts, white papers, and articles, and provides medical review of oncology communication materials.
• Builds and maintains a network of Key Opinion Leaders (KOLs) and investigators in the targeted indications.
• Maintains awareness of the competitive landscape in the targeted indications, emerging standards of care, and trends in sponsor development pipelines.

Contribution to business growth:

• Partners with Business Development as the senior medical and scientific resource in oncology opportunities.
• Provides the medical and scientific rationale behind study design, feasibility, and delivery strategy in support of new business.
• Draws on their own professional network to open and develop sponsor relationships in coordination with Business Development.

Qualifications

• Medical degree (MD).
• Specialist medical training.
• At least 10 years of post-qualification medical experience.
• At least 7 years of oncology/haematology clinical development experience.
• Substantial experience in the Medical Director role or equivalent in a CRO, biotechnology, or pharmaceutical organization.
• Hands-on experience as medical monitor in oncology clinical trials.
• Member of safety data review boards in clinical trials, or equivalent experience.
• Understanding of Good Clinical Practice regulations, ICH guidelines, and Pharmacovigilance legislation.
• Excellent written and verbal communication skills.
• Able to work in a fast-paced environment with changing priorities.
• Willingness to travel internationally for sponsor meetings and scientific events.

Requirements

• Experience of sponsor-facing scientific work in a CRO, pharmaceutical, or biotechnology environment.
• Comfortable in sponsor-facing settings, with the ability to translate scientific depth into a clear and credible message.
• Established external scientific profile in oncology, including publications and congress presentations.

Benefits

• Competitive compensation package.
• Comprehensive benefits.
• Opportunity for personal and professional growth in a rewarding environment.

Company Description

TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our journey began over 30 years ago in Sweden, in the city of Lund. As a full-service, global CRO, we build solution-driven teams working towards a healthier future.

• Bringing together over 600 professionals.
• Delivering tailored clinical research services in more than 50 countries.
• Flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology, Neuroscience, Oncology, and Ophthalmology.
• Core values of Trust, Quality, Passion, Flexibility, and Sustainability.