Medical Director

4 days ago

Dublin, Dublin City, Ireland Wep Clinical Full time

Do you want to be a part of a team that gives hope to patients with rare and life-threatening diseases?
Do you thrive in an innovative, growth-oriented environment?
At WEP Clinical, we are looking for an experienced Medical Monitor interested in joining us in an exciting phase of high growth and helping us shape the future of clinical research.

Role Objectives: The Medical Director at WEP Clinical serves as the primary medical and scientific expert for clinical trial protocols and Expanded Access Programs (EAPs), playing a crucial role in ensuring the accuracy, integrity, and successful execution of studies.
As the protocol expert, the Medical Director is responsible for guiding investigators and internal/external teams in implementing and adhering to the study protocol.
This includes but is not limited to medical and safety monitoring, data interpretation/presentation, and providing expert input on all medical aspects of the trial.
As a Medical Director, you'll collaborate with clinical, regulatory, and operational teams to ensure trials meet the highest ethical and scientific rigour standards.

The Ideal Candidate: Detail-oriented Proactive Collaborative What You'll Do: Act as the primary point of contact for all medical-related inquiries from investigators, regulatory agencies, and internal/external teams, providing clarification and ensuring consistent protocol interpretation.
Monitor the clinical trial and/or Expanded Access Programs (EAP) to ensure participant's safety, data accuracy, and compliance with the protocol.
Address medical issues as they arise throughout the study and/or program.
Participate in discussions with investigators during the site selection phase to assess their experience and suitability for the trial and/or programs.
Book and lead conference calls with investigators to discuss inclusion/exclusion criteria and provide personalized attention to ensure optimal site selection and patient recruitment.
Serve as the primary medical expert for the clinical trial protocol, ensuring full comprehension and adherence by investigators, study teams, and stakeholders.
Review adverse events (AEs), serious adverse events (SAEs), and other safety-related reports to ensure proper documentation and timely reporting.
Provide causality assessment of adverse events (AEs), especially those that may request expedited reporting to regulatory authorities.
Work with Data Safety Monitoring Boards (DSMBs) and other safety committees to provide safety oversight and evaluate ongoing trial data for participant safety.
Provide ongoing training and support to investigators, site staff and internal/external teams on the protocol and therapeutic area, ensuring thorough understanding and adherence to the medical and scientific objectives of the study.
Participate in investigator meetings, site initiation visits, and study-related training to present and explain protocol-related issues, clarify eligibility criteria, and address any medical concerns.
Lead protocol, treatment guidelines and other project documents by providing key medical input on study design, endpoints, inclusion/exclusion criteria, and overall trial/program methodology.
Provide oversight to ensure that study conduct aligns with the protocol, identifying, classifying, and resolving any deviations, as well as ensuring the scientific and ethical integrity of the trial.
Collaborate closely with clinical operations, regulatory, and project management teams to ensure trials comply with Good Clinical Practice (GCP) and regulatory requirements.
Work with pharmacovigilance teams to ensure timely and accurate safety reporting and management of safety signals during the trial.
Represent Medical Affairs in marketing and sales efforts by developing project bid proposals, participating in bid defence meetings or performing client presentations, as requested.
Provide expert medical guidance in cross-functional meetings, helping to resolve protocol-related challenges and ensuring the scientific objectives of the trial are met.
What You'll Need: Medical Doctor (MD) degree or PhD in health-related field required.
At least 5+ years of relevant clinical research experience, preferably medical monitoring.
Ability to travel internationally and domestically up to 25% 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.
What sets us apart: WEP Clinical partners with sponsors to help patients and physicians gain early access to medicines when no other treatment options are available.
WEP Clinical has over 15 years of experience distributing products to over 120 countries worldwide to treat unmet patient needs.

We're Committed to Our Team: WEP has many initiatives to encourage wellness, growth and development, and team relationships.
Check out our LinkedIn Life Page to learn more about our team events, and all that we do to support our employees.

We're Committed to DEI: At WEP Clinical, acceptance, recognition, and engagement are the core of our DEI values.
We are committed to giving employees opportunities for personal and professional success and growth, embracing everyone's unique identities.

Our services include: Expanded Access Programs (EAPs)
Named Patient Programs (NPPs)
Clinical Trial Supplies (Comparator & Ancillaries)
Wren Nursing (Clinical Trial Home Nursing & Clinical Education)
Hospital Supply of Unlicensed Medicines
WEP Clinical is a smoke-free, drug-free, and alcohol-free work environment.
WEP Clinical is an equal-opportunity employer.
WEP Clinical does not unlawfully discriminate against employees or applicants for employment based on an individual's race, colour, religion, creed, sex, sexual orientation, gender identity or expression, national origin, genetic information, age, disability, marital status, veteran status or any other status protected by applicable law.
This policy applies to all terms, conditions, and privileges of employment, including recruitment, hiring, placement, compensation, promotion, discipline, and termination.
WEP Clinical will make reasonable accommodation for qualified individuals with known disabilities, in accordance with applicable law.

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