Medical Director

🔥 15 hours ago

🇮🇪 Ireland – Remote

⏰ Full Time

🔴 Lead

👨‍⚕️ Medical Director

👻 Ghost score 10%

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WEP Clinical

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2008

💼 Consulting

📦 Logistics

💊 Pharmaceuticals

Consulting • Logistics • Pharmaceuticals

WEP Clinical is a Pharmaceutical Services Provider that specializes in Drug Development Programs, Treatment Access Solutions, and Market Access and Commercialization. The company focuses on providing critical support throughout the entire drug development and commercialization journey, helping sponsors advance their medicines and improve patient access. WEP Clinical offers services such as clinical trial services, expanded access programs, post-approval named patient programs, and market access consulting, ensuring that much-needed therapies reach patients worldwide.

📋 Description

• Serve as the primary medical point of contact for investigators, regulatory agencies, and internal/external teams • Ensure consistent protocol interpretation and address medical inquiries • Monitor clinical trials and Expanded Access Programs for participant safety, data accuracy, protocol compliance, and timely resolution of medical issues • Participate in investigator discussions during site selection • Lead investigator calls to review inclusion/exclusion criteria and support site selection and patient recruitment • Act as the primary medical expert for the protocol and ensure adherence across stakeholders • Review and ensure proper documentation and timely reporting of AEs, SAEs, and other safety events • Provide causality assessments for adverse events, including those requiring expedited regulatory reporting • Work with DSMBs and safety committees to provide safety oversight and evaluate ongoing trial data • Deliver training and support to investigators, site staff, and internal/external teams • Participate in investigator meetings, site initiation visits, and study training • Lead development of protocols, treatment guidelines, and project documents with medical input on design, endpoints, criteria, and methodology • Oversee protocol adherence and manage deviations • Collaborate with clinical operations, regulatory, project management, and pharmacovigilance teams • Support safety reporting and represent Medical Affairs in bid proposals, bid defences, client presentations, and cross-functional scientific discussions

🎯 Requirements

• A Medical Doctor (MD) degree is required • At least 5+ years of relevant clinical research experience, preferably medical monitoring • Ability to travel internationally and domestically up to 15% • Experience in EAP / CUP / NPP is preferred • Proven experience in protocol development, implementation, and interpretation • Experience in safety monitoring, adverse event reporting, and medical data review in the context of 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 • Exceptional leadership, communication, and interpersonal skills to collaborate effectively with diverse teams and external stakeholders • 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 are required to work independently and in a team environment • Resume must be submitted in English

🏖️ Benefits

• Group Private Medical Insurance • Group General Life Assurance • Group Critical Illness and Group Income Protection • Salary sacrifice pension scheme • Enhanced maternity & paternity pay • Educational Assistance allowance • Paid volunteering day • Wellness, growth, development, and team relationship initiatives • Team events • Inclusive, supportive work environment • Equal-opportunity employment and reasonable accommodation for qualified individuals with known disabilities