(Senior) Medical Director, Gastrointestinal
hace 2 meses
When our values align, there's no limit to what we can achieve.
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. From clinical trials to regulatory, consulting, and market access, our therapeutic, technical, and functional ability is underpinned by a deep conviction in what we do. We believe in our values; Patients First, Quality, Respect, Empowerment & Accountability.
Parexel is looking for a Medical Director/Senior Medical Director with a strong background in Gastroenterology.
Must have completed Gastroenterology specialty training and have clinical experience in this area.
The role can be based remo t ely in select EMEA locations.
The Medical Director is a medical expert with specialized therapeutic expertise and some experience across indications, clients and drug development. They initiate and maintain medical and consultative relationships with clients, consult on early engagement and pre-award efforts and serve as a medical monitor for contracted projects. The Medical Director may take on leadership roles by participating in initiatives, mentoring junior MDs and/or, where appropriate, managing a team of physicians.
KEY ACCOUNTABILITIES:
Project Execution: Medical Monitoring Delivery & PV Support
Independently deliver all medical support required for successful delivery of the projects according to contracted agreement with the sponsor (i.e., tasks and time per task contracted) and according to the assigned role (Global Lead Physician or Regional Lead Physician)
Participate actively in study planning with feasibility leaders, solution consultants
Participate in team project and investigator meetings
Provide training of study teams on TA indication and protocol (Note that this does not include any direct medical advice on patient care or management)
Communicate with relevant sponsor counterparts on challenges and accomplishments related to assigned project/study
Participate in the development and/or review of study documents, such as clinical protocols, Medical Monitoring Plans (MMP), integrated clinical and statistical summary reports, safety plans, Informed Consent Forms, etc. in conjunction with clients/sponsors or in conjunction with other Parexel departments
Deliver medical monitoring activities according to MMP during the study conduct
Deliver medical leadership to the project in close coordination with the Project Leader and according to the role assigned either GLP or RLP
Provide medical input into PV workflows and projects and participate in safety processing for studies including medical review of serious adverse events
Client Relationship Building & Engagement
Support Business Development
Provide medical expertise to client across multiple channels and interactions
Consultancy on protocol development or drug development program
Medical review of various documents, which might be audited by clients and regulatory agencies
Provide medical expertise and training to other Parexel colleagues
KNOWLEDGE & EXPERIENCE:
Must have completed gastroenterology specialty training to be considered for the role.
Clinical and/or research experience in MASH (metabolic associated liver disease) and/or IBD
A background in clinical aspects of drug development, including all aspects of Medical Monitoring and study design/execution preferred.
Clinical practice experience
Good knowledge of the drug development process including drug safety, preferred
Experience in Pharmaceutical Medicine, preferred
Experience leading, mentoring and managing individuals/ a team, preferred
Excellent English language skills
EDUCATION:
Medically qualified in an acknowledged medical school with completion of at least a basic training in clinical medicine
SKILLS:
Excellent interpersonal skills including the ability to interact well with sponsor/client counterparts
Client-focused approach to work
Excellent time management skills
Excellent verbal and written medical communication skills
Excellent standard of written and spoken English
A flexible attitude with respect to work assignments and new learning
Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail
Willingness to work in a matrix environment and to value the importance of teamwork
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