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WEP Clinical

Specialist services for early access medicines

Responsible Person

Full-TimeUpdated on 10/23/2026
No salary listed
Expert
Bachelor's
Dublin, Ireland
In Person
Biology & BiotechRegulatory & Quality (Life Sciences)

About the job

Requirements
  • A bachelor's degree or higher is required; a concentration in pharmaceutical, life sciences, or engineering is preferred.
  • Significant experience and demonstrated industry knowledge, preferably in a Good Distribution Practice setting.
  • Completion of the Responsible Person training program and/or refresher program.
  • Extensive knowledge of GxP requirements, including Good Manufacturing Practice, Good Distribution Practice, and Good Clinical Practice for EU, FDA, and WHO requirements, and appropriate regional research regulations and guidelines.
  • Extensive knowledge of Good Distribution Practice national regulations and associated guidelines, with the ability to interpret legislation and assess requirements.
  • Ability to use the Microsoft Office Suite proficiently, including Word, Excel, and PowerPoint.
  • Ability to work to strict deadlines with a high level of accuracy.
  • Strong organizational, planning, and administrative skills, with attention to detail and self-motivation.
  • Effective verbal and written communication and interpersonal skills.
  • Ability to use initiative, think critically, and make effective decisions.
Responsibilities
  • Ensure a quality management system is implemented and maintained, including review and approval of Good Distribution Practice procedures, and remain continually contactable as the Responsible Person.
  • Ensure Quality Risk Management principles are applied to all Responsible Person duties and obligations under the Falsified Medicines Directive are met.
  • Participate in Quality Management Review Meetings, ensure minutes are taken, and bring actions to closure in a timely manner.
  • Assess and approve Good Distribution Practice Change Controls, with oversight of Deviations and Corrective and Preventive Actions as appropriate.
  • Manage authorised activities and ensure the accuracy and quality of records.
  • Ensure initial and continuous training programmes are implemented and maintained, and keep up to date with legislative changes and identified ongoing training.
  • Coordinate and promptly perform medicinal product recall operations, and ensure relevant customer complaints are handled effectively.
  • Ensure suppliers and customers are approved.
  • Approve subcontracted activities that may impact Good Distribution Practice, including contracts between the contract giver and acceptor specifying their responsibilities for wholesaling activities such as storage, distribution, and transportation of medicinal products.
  • Ensure self-inspections are performed at regular intervals under a prearranged programme, and put necessary corrective measures in place.
  • Decide on the final disposition of returned, rejected, recalled, or falsified products; approve returns to saleable stock; and ensure additional requirements imposed on certain products by national law are followed.
  • Delegate duties during absences and keep appropriate records of delegation.
  • Provide line management, including setting clear objectives, supporting development, and managing performance.
  • May take on responsibility as Deputy Responsible Person for the UK.
Desired Qualifications
  • A pharmaceutical, life sciences, or engineering concentration.
  • Industry experience in a Good Distribution Practice setting.

About the company

WEP Clinical provides access to unlicensed or scarce medicines through Expanded Access Programs (EAP) and Managed Access Programs (MAP) for hospitals and physicians in over 60 countries. It uses a global sourcing network and handles import authorizations to obtain medicines that aren’t commercially available or are in short supply. A team of country managers and in-house pharmacists with local language skills coordinates and ships medications to healthcare providers. Revenue comes from service fees for managing access programs and sourcing medicines, with the goal of getting necessary treatments to patients quickly.

Company Size

201-500

Company Stage

N/A

Total Funding

N/A

Headquarters

London, United Kingdom

Founded

2008

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Simplify's Take

What believers are saying

  • July 2026 Chiswick Business Park office signals headcount growth and stronger London recruiting.
  • Case-study expansion into real-world data and French early access widens wallet share in 2026.
  • More rare-disease and shortage programs increase demand for WEP’s authorization and logistics expertise.

What critics are saying

  • Siron integration in 2026 distracts management and risks service failures across Europe.
  • WEP depends on sponsor programs like DANYELZA, TROGARZO, and HYFTOR; lost renewals hit revenue fast.
  • A MHRA, EMA, or FDA compliance failure can freeze imports and destroy WEP’s core business.

What makes WEP Clinical unique

  • WEP Clinical pairs expanded access programs with Phase I-IV CRO services across 60+ countries.
  • January 2026 Siron Clinical acquisition adds orphan, pediatric, and device trial execution capacity.
  • WEP’s named-patient, early-access, and post-trial supply workflows solve hard cross-border authorization problems.

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Benefits

  • Health Insurance
  • Disability Insurance
  • Life Insurance
  • Parental Leave
  • Flexible Work Hours
  • Training Programs

Growth & Insights and Company News

6 month growth

31%

1 year growth

31%

2 year growth

31%
WEP Clinical
Jul 1st, 2026
WEP Clinical announces new London office at Chiswick Business Park.

WEP Clinical announces new London office at Chiswick Business Park. WEP Clinical, a global Clinical Research Organization (CRO) supporting biopharmaceutical partners across the full drug development lifecycle, is pleased to announce the opening of its new London office at Chiswick Business Park. The move marks a deliberate step forward for WEP Clinical as the company experiences significant momentum across its phase 1-4 clinical trial management services and reflects a broader commitment to ensuring its people have access to a workspace that matches the quality and ambition of the work they deliver. Chiswick Business Park is one of west London's most respected business destinations, comprising 1.8 million square feet of award-winning office accommodation and a community built around the belief that people do their best work when they enjoy where they work. That philosophy resonates strongly with WEP Clinical's own people-first culture and its focus on collaboration, wellbeing, and shared success. "As WEP Clinical continues to grow, particularly across our clinical trial management offering, it felt like the right moment to ensure our London team has an environment that truly reflects who we are as a company," said Jas Khera, CEO and Founder of WEP Clinical. "Chiswick Park is a genuinely exceptional place to work, and we are excited to bring our team into a space designed for connection, innovation, and the kind of high-quality thinking our partners and their patients depend on." The new office provides modern, flexible workspaces that support cross-functional collaboration and reinforce WEP Clinical's commitment to building a culture where people can thrive. It further strengthens the company's UK presence as WEP continues to expand its global footprint and deepen its partnerships across the biopharmaceutical industry. About WEP Clinical WEP Clinical is a global CRO with expertise in designing, managing, and executing phase 1-4 Clinical Trials, Expanded and Post-Trial Access Programs, and Clinical Trial Home Nursing solutions across multiple therapeutic areas. With a strong focus on proactive project management, scientific integrity, regulatory compliance, and patient-centric execution, WEP supports pharmaceutical and biotech companies in bringing life-changing therapies to market and creating broader treatment access opportunities for patients. Learn more at www.wepclinical.com.

WEP Clinical
Jan 5th, 2026
WEP Clinical Acquires Siron Clinical

WEP Clinical acquires Siron Clinical. WEP Clinical acquires Netherlands-based CRO Siron Clinical, expanding global Phase I - IV trial delivery capabilities. Morrisville, NC, USA & London, UK - [January 05, 2026] - WEP Clinical (WEP), a full-service contract research organization (CRO), today announced the acquisition of Siron Clinical (Siron), a Netherlands-based European CRO specializing in flexible, high-quality clinical operations for biotech companies. The acquisition expands WEP's global footprint and strengthens its ability to deliver end-to-end Phase I - IV clinical trial solutions across complex, rare, and specialized therapeutic areas. Founded in 2000, Siron is headquartered in the Netherlands, with additional offices in Belgium and Germany, and clinical research professionals based across Europe and the Middle East. The company specializes in clinical operations, including project management, clinical monitoring, quality assurance, and regulatory submissions. Siron has supported more than 120 studies and is recognized for its strong track record in orphan diseases, pediatric research, and medical device trials. "This acquisition represents a significant milestone in the evolution of our CRO services. By combining WEP's global infrastructure with Siron Clinical's deep operational expertise in complex and niche indications, we can offer sponsors seamless support from early-phase development through post-approval research. Our shared culture, values, and commitment to execution excellence make this an ideal strategic fit, and we look forward to accelerating innovation and impact together." "Joining WEP gives our clients access to expanded services and global reach, while preserving the flexible, hands-on approach they value. We share WEP's commitment to quality, transparency, and patient-focused delivery, and together we will provide a more robust and scalable solution for biotech sponsors worldwide." Siron will be integrated into WEP's Clinical Trials division, enhancing WEP's existing capabilities across trial design, regulatory strategy, start-up, patient recruitment, study execution, and close-out. Clients will benefit from a larger pool of experienced CRAs, project managers, and operational leaders, alongside WEP's broader treatment access and commercialization offerings. WEP Clinical is a global Clinical Research Organization with expertise in designing, managing, and executing clinical trials across multiple therapeutic areas. With a strong focus on proactive project management, scientific integrity, regulatory compliance, and patient-centric execution, WEP supports pharmaceutical and biotech companies in bringing life-changing therapies to market efficiently and safely. Siron Clinical is a European CRO providing flexible and scalable clinical operations expertise for biotech organizations. With more than two decades of experience executing complex clinical trials, Siron delivers localized insight, hands-on support, and adaptive solutions across the clinical development journey.

WEP Clinical
Dec 1st, 2023
WEP CLINICAL HAS PARTNERED WITH PLUSULTRA PHARMA TO SUPPLY HYFTOR(R) TO PATIENTS IN EU/EEA COUNTRIES (WITH THE EXCEPTION OF GERMANY)

WEP Clinical has partnered with Plusultra pharma to supply HYFTOR(R) to patients in EU/EEA countries (with the exception of Germany).

TAIMED Biologics
Feb 3rd, 2023
TaiMed

WEP Clinical LTD (WEP), a specialist services company that works with pharmaceutical companies to help patients and physicians gain access to medicines when no other treatment options are available, has partnered with TaiMed Biologics to launch a Named Patient Program (NPP) for TROGARZO®, an IV treatment administered every two weeks for patients with muti-drug resistant HIV disease.

Yahoo Finance
Dec 21st, 2022
Y-mAbs Announces Partnership Regarding Early Access Program for DANYELZA (naxitamab-gqgk) in Europe

Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, today announced that it has entered into a distribution agreement with WEP Clinical Ltd. (“WEP”) in connection with an early access program for DANYELZA (naxitamab-gqgk) 40mg/10mL Injection in Europe.