Parexel is in the business of improving the world’s health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments.
We are currently seeking a Medical Director with specialist expertise in Rheumatology to join our team in either Serbia, Czechia or Hungary.
The Medical Director is an experienced Rheumatologist with specialist clinical training in Rheumatology and current, up-to-date expertise across rheumatological diseases. Experience supporting clinical development programmes or clinical trials in areas such as rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis, lupus or other immune-mediated inflammatory diseases would be highly advantageous
You will initiate and maintain medical and consultative relationships with clients, contribute to early engagement and pre-award activities, and serve as a Medical Monitor for contracted clinical studies.
Key Accountabilities
Project Execution: Medical Monitoring Delivery & PV Support
- Independently deliver the medical support required for the successful delivery of assigned projects in accordance with the contracted agreement with the sponsor and your assigned role as Global Lead Physician (GLP) or Regional Lead Physician (RLP).
- Participate actively in study planning alongside feasibility leaders, solution consultants and cross-functional study teams.
- Participate in project team and investigator meetings.
- Provide training to study teams on rheumatology indications, disease areas, relevant clinical considerations and study protocols.
- Communicate with relevant sponsor counterparts regarding medical matters, challenges, risks and accomplishments relating to assigned projects and studies.
- Participate in the development and/or medical review of study documents, including clinical protocols, Medical Monitoring Plans (MMPs), integrated clinical and statistical summary reports, safety plans and Informed Consent Forms, in conjunction with clients/sponsors and other Parexel departments.
- Deliver medical monitoring activities in accordance with the Medical Monitoring Plan throughout study conduct.
- Provide medical leadership to projects in close coordination with the Project Leader and in accordance with the assigned GLP or RLP responsibilities.
- Provide medical input into pharmacovigilance workflows and projects, including participation in safety processing and the medical review of serious adverse events.
Client Relationship Building & Engagement
- Build and maintain strong medical and consultative relationships with clients and sponsor stakeholders.
- Provide expert medical input and advice relating to rheumatology clinical development programmes and studies.
- Act as a credible medical partner to clients throughout the lifecycle of assigned programmes.
Business Development & Medical Expertise
- Support Business Development and early engagement activities by providing therapeutic and medical expertise.
- Provide medical expertise to clients across multiple channels and interactions.
- Provide consultancy on protocol development and/or broader drug development programmes.
- Conduct medical review of clinical and regulatory documentation that may be subject to client or regulatory agency review.
- Provide rheumatology expertise, guidance and training to colleagues across Parexel.
- Contribute medical and therapeutic expertise to proposals, bid-defence activities and client discussions, where appropriate.
Knowledge & Experience
- Medical qualification with relevant postgraduate clinical training and specialist expertise in Rheumatology.
- Current and up-to-date knowledge of rheumatology and the management of relevant inflammatory, autoimmune and musculoskeletal diseases.
- Clinical practice experience within Rheumatology.
- A background in the clinical aspects of drug development, including experience with Medical Monitoring and clinical study design and/or execution.
- Experience within rheumatology clinical research or clinical trials is highly desirable.
- Good knowledge of the drug development process, including drug safety/pharmacovigilance, preferred.
- Experience in Pharmaceutical Medicine is preferred.
- Experience leading, mentoring and/or managing physicians or multidisciplinary teams is preferred.
- Excellent written and spoken English.
Education
- Medically qualified from a recognised medical school, with completion of appropriate postgraduate clinical training.
- Postgraduate specialist training or recognised specialist qualification in Rheumatology is strongly preferred.
Skills
- Excellent interpersonal skills, including the ability to build credible relationships with sponsor and client counterparts.
- Strong client-focused approach to work.
- Excellent time-management and organisational skills.
- Excellent verbal and written medical communication skills.
- Excellent standard of written and spoken English.
- A flexible approach to work assignments and an enthusiasm for continued learning.
- Ability to manage multiple and varied tasks, prioritise effectively and maintain a high level of attention to detail.
- Ability and willingness to work effectively within a global, cross-functional matrix environment.
- Strong appreciation of teamwork and collaboration across medical, clinical, safety and operational functions.
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