Medical Director

Medical Director

TFS HealthScience

Warsaw, Poland

Key Responsibilities

Clinical Strategy & Pipeline Management

• Managing the clinical development portfolio of several projects: Oversight of early‑phase clinical trials (Phase I–II) in systemic/autoimmune/oncological diseases conducted in key locations (Europe, USA), including trial design in collaboration with the medical team, medical key opinion leaders, and external consultants;
• Regulatory strategy: Participation at both strategic and operational levels in scientific procedures with key regulatory authorities (EMA, FDA) for drugs in development.

Vendor & CRO Performance Management

• Oversight of subcontractors (CROs): Sponsor-level oversight through sponsor operational managers to ensure completion of key milestones according to the clinical study schedule;
• Quality and performance management: Ensuring the highest quality standards from subcontractors in line with current regulations and good practices (GxP), and delivery of reliable clinical data within agreed timelines;
• Budget optimization: In collaboration with operational managers, management of clinical trial budgets, including cost monitoring and negotiating scopes of work to avoid unjustified costs;
• Operational effectiveness: Implementing corrective actions with CROs in cases of recruitment or reporting delays; requiring a proactive approach from vendors to ensure timely completion of each study phase.

Medical Leadership & Clinical Operations

• Scientific oversight: Acting as the key medical authority for protocol design, clinical study documentation (including Investigator Brochures and Development Safety Update Reports), medical monitoring, patient safety (pharmacovigilance), clinical study results reporting, and interactions with external committees such as DSMB and DMC;
• Team management: Building and scaling the internal Clinical Development & Operations team;
• Relationships with medical key opinion leaders and clinical sites: Maintaining strategic relationships to support recruitment and outcome interpretation in relevant therapeutic areas;
• Scientific publications: Initiating and co-editing publications in medical journals and conference abstracts related to ongoing clinical studies.

Support for Business Development

• Interactions with potential and current clinical development partners: Participation in meetings, presentations, and negotiations with potential business partners (pharmaceutical companies, biotech firms, investment funds) concerning ongoing and completed sponsored clinical projects.

Qualifications

• Medical qualifications: Medical degree (MD); additional assets include experience in clinical development of drugs in systemic/autoimmune/oncological diseases, or specialization in internal medicine, immunology, pulmonology, or oncology;
• CRO management: Minimum of 10 years of experience in clinical drug development, including at least 5 years in sponsor organizations, with documented success in direct management and collaboration with CROs;
• Experience with multi-center and international trials: Practical expertise in conducting decentralized trials (especially in the USA and Europe), including knowledge of regulatory specifics in both regions;
• Project management: Experience managing studies of different phases simultaneously.