The posting
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 expertise includes full service-capabilities, resourcing and Functional Service (FSP) solutions.
Join Our Team as a Senior Medical Director - home based in Spain, Germany, Sweden, UK, Poland or Portugal
About this role
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. The role combines hands-on medical monitoring and portfolio-level medical oversight with responsibility for the scientific credibility and visibility of the company with current and future sponsors across the targeted indications in oncology and hematology defined for the therapeutic area (referred to below as the targeted indications).
The Senior Medical Director retains full medical authority: providing an authoritative medical opinion, answering medical based questions concerning medical, legal and regulatory matters, and acting in accordance with company policies, Standard Operating Procedures (SOPs) and regulatory requirements. The role acts as medical monitor for assigned oncology studies and, in parallel, provides medical oversight and escalation across the wider oncology portfolio. The role also partners with Business Development to support the growth of the oncology business, contributing medical and scientific expertise to bid strategy, proposals, bid defense meetings and sponsor relationships.
Key Responsibilities:
Medical leadership and medical monitoring:
- 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, strengthening both the scientific credibility of the company and its access to new opportunities.
- Maintains awareness of the competitive landscape in the targeted indications, emerging standards of care and trends in sponsor development pipelines and feeds these insights into therapeutic area strategy and the oncology leadership team.
Contribution to business growth:
- Partners with Business Development as the senior medical and scientific resource in oncology opportunities, contributing to bid strategy, proposals, bid defence meetings and sponsor discussions.
- Provides the medical and scientific rationale behind study design, feasibility and delivery strategy in support of new business, and presents that thinking to sponsors.
- Draws on their own professional network to open and develop sponsor relationships in coordination with Business Development and contributes to the oncology therapeutic area strategy and service offering together with Business Development, Commercial Operations and the oncology leadership team.
Qualifications:
Essential:
- 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 and 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, including review of emerging safety data and medically based decision-making during study conduct.
- Member of safety data review boards in clinical trials, or equivalent experience.
- Understanding of Good Clinical Practice regulations, International Council for Harmonisation (ICH) guidelines, Pharmacovigilance legislation and internal Standard Operating Procedures.
- 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.
Desirable:
- Experience of sponsor-facing scientific work in a Contract Research Organisation (CRO), pharmaceutical or biotechnology environment, such as input to bid strategy, proposals, bid defence meetings or capability presentations.
- Comfortable in sponsor-facing settings, with the ability to translate scientific depth into a clear and credible message.
- Established external scientific profile in oncology, for example publications, congress presentations, advisory board participation or an active Key Opinion Leader (KOL) network.
What We Offer
We provide a competitive compensation package, comprehensive benefits and the opportunity for personal and professional growth in a rewarding environment. You’ll be joining a team that values collaboration, innovation, and making a difference in the lives of patients
For candidates based in Spain - TFS is committed to equal opportunities. All our vacancies are open to people with disabilities, in accordance with the General Law on the Rights of Persons with Disabilities (Royal Legislative Decree 1/2013).
A Bit More About Us
Our journey began over 30 years ago in Sweden, in the city of Lund. As a full-service, global Contract Research Organization (CRO), we build solution-driven teams working towards a healthier future. Bringing together over 600 professionals, TFS delivers tailored clinical research services in more than 50 countries with flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology, Neuroscience, Oncology and Ophthalmology.
Our core values of Trust, Quality, Passion, Flexibility, and Sustainability are our guiding light serving as the framework for decision-making at all levels of the organization. They assist us in attracting and retaining valuable talent who share our sentiments, resulting in high employee engagement and satisfaction. By aligning on these fundamental values, we cultivate a unified force, geared towards innovation and excellence. This collective effort propels us towards our shared goal and fosters a culture of mutual respect and collaboration.
Together we make a difference.
