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WEP Clinical

Specialist services for early access medicines

Medical Director

Biology & BiotechConfirmed live in the last 24 hours
Full-timeNo salary listed

About the Job

Requirements

  • A Medical Doctor (MD) degree is required.
  • At least 5 years of relevant clinical research experience, preferably in medical monitoring.
  • Ability to travel internationally and domestically up to 15%.
  • Experience in protocol development, implementation, and interpretation.
  • Experience in safety monitoring, adverse event reporting, and medical data review in clinical trials.
  • In-depth knowledge of clinical trial design, regulatory requirements, and drug development processes.
  • Computer literacy and proficiency in Microsoft Office, particularly Excel, Word, and PowerPoint.
  • Strong analytical and problem-solving abilities to make data-driven decisions and navigate complex challenges in the healthcare sector.
  • Excellent interpersonal, communication, and organizational skills to work independently and in a team environment.

Responsibilities

  • Serve as the primary medical point of contact for investigators, regulatory agencies, and internal and external teams, ensuring consistent protocol interpretation and addressing medical inquiries.
  • Monitor clinical trials and Expanded Access Programs to ensure participant safety, data accuracy, protocol compliance, and timely resolution of medical issues.
  • Participate in investigator discussions during site selection to assess suitability and study or program experience.
  • Lead investigator calls to review inclusion and exclusion criteria and support site selection and patient recruitment.
  • Act as the primary medical expert for the protocol, ensuring understanding and adherence across investigators, study teams, and stakeholders.
  • Review and ensure proper documentation and timely reporting of adverse events, serious adverse events, and other safety events.
  • Provide causality assessments for adverse events, including those requiring expedited reporting to regulatory authorities.
  • Work with Data and Safety Monitoring Boards and safety committees to provide safety oversight and evaluate ongoing trial data.
  • Deliver ongoing training and support to investigators, site staff, and internal and external teams on protocol requirements and the study’s medical and scientific objectives.
  • Participate in investigator meetings, site initiation visits, and study training to present protocol details, clarify eligibility criteria, and address medical concerns.
  • Lead the development of protocols, treatment guidelines, and project documents by providing medical input on design, endpoints, criteria, and methodology.
  • Oversee protocol adherence, manage deviations, collaborate with clinical operations, regulatory, project management, and pharmacovigilance teams, support safety reporting, and represent Medical Affairs in bid proposals, bid defenses, client presentations, and cross-functional scientific discussions.

Desired Qualifications

  • Experience in Expanded Access Programs (EAP), Compassionate Use Programs (CUP), or Named Patient Programs (NPP) is preferred.

About the Company

WEP Clinical

Specialist services for early access medicines

WEP Clinical provides access to unlicensed or scarce medicines through Expanded Access Programs (EAP) and Managed Access Programs (MAP) for healthcare providers in 60+ countries. It designs and runs these programs, coordinates with manufacturers and regulators, and sources medicines via a global network, with import authorizations and logistics handled by country managers and in-house pharmacists. Its approach combines global sourcing with local expertise and an end-to-end program model, differentiating it from others that rely on limited markets or suppliers. Its goal is to deliver needed treatments quickly when options are unavailable.

Company size
201-500
Company stage
Not listed
Total funding
Not listed
Headquarters
London, United Kingdom
Founded
2008

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