Associate Director, Early Access Program
A leading biotechnology company is advertising a vacancy for an Associate Director, Early Access Program. This is an exciting opportunity for an experienced and motivated applicant to develop a career in a truly revolutionary field.
- Working cross-functionally and directly with the selected EAP vendor(s) to manage EAP-related activities, day to day operations and budgets.
- Playing a key role in collaboration with physicians and site personnel to facilitate timely review and approval of EAP protocols and other related documents.
- Leading effort in planning and execution of the company's EAP strategy and program across all therapeutic areas to address unmet need in the CEMEA region.
- Supporting Director, EAP in developing EAP strategic plans across all therapeutic areas in the CEMEA region.
- Collaborating with key internal stakeholders to ensure compliant execution of EAP objectives, including planning, addressing HCP questions, facilitate review and approval of EAP protocols and other related documents.
- Acting as the primary point of contact with EAP vendor for the CEMEA region, accountable for relationship and budget pertaining to EAP in the CEMEA region.
- Providing support to local / regional medical team in address questions from healthcare professionals, including development of presentations, patient advocacy meetings, and other appropriate venues to enhance EAP understanding.
- Supporting Director, EAP in developing appropriate policy and training documents and ensure local / regional medical team in the CEMEA region is appropriately trained about EAP process and relevant policy and regulations.
- Providing operational support to all EAP related activities in the CEMEA region.
Skills and Requirement:
- Bachelor's and/or Master's degree in life sciences required.
- Advanced degree such as MD, PharmD, or PhD level scientific education a plus.
- Demonstrated experience working within Medical Affairs or Medical Operations.
- Experience in clinical research and clinical operations preferred but not required.
- Expanded access / compassionate use experience preferred but not required.
- Experience managing an external vendor partner required; successful negotiation and management of a contract / budget a plus.
- Excellent communication, presentation and time management skills; must be adaptable and able to work well within a team and relate effectively with people at all levels of the organisation.
- Demonstrated leadership in ambiguous situations.
- Working knowledge of legal, regulatory, and compliance regulations and guidelines preferred.
- Ability to partner with key internal stakeholders to understand the company's key objectives, and to drive plans that exceed these.
- Travel up to 25%.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Edward White at +44 203 854 2622 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.