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Are you ready to make your mark in the healthcare industry using your ingenuity and technical expertise? At Parexel, there's no limit to what you can accomplish. We work with the top 50 global pharmaceutical companies, the top global biotech companies, and hundreds of small and emerging companies. We've supported the development of some of the most important treatments of our time, including nearly all of the 50 top selling drugs currently on the market. Join us and you'll make a profound difference in millions of lives. With a role in our Information Technology group, you'll work with cutting-edge technology on internal and client-facing projects. Collaborating with people from all over the world and touching everything from enterprise systems and clinical applications to infrastructure and networking, you'll keep our data safe and confidential. You'll have the chance to develop your skills and pursue advancement opportunities that include managerial and technical tracks. If you have stellar coding and design experience and a passion to learn more about healthcare, Parexel invites you to discover our rewarding opportunities in Enterprise Architecture, Software Development, Project Management and Business Analysis, and more. In a global clinical trial environment, business-focused applications, connectivity, and data security are critical to a trial's outcome. Find out how you can be an invaluable part of our success story.

Medical Director - Dermatology

Job ID R0000033299 , Poland

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.

We are looking for an AssociateMedical Director/Medical Director to be based in Poland or other select European locations as noted in the job advertisement.

Must be a Dermatologist, MD and board-certified or local equivalent

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: (5-10 years)

  • Dermatologist, MD and board-certified or local equivalent

  • Prior CRO or biotech / pharma experience (desired)

  • A background in clinical aspects of drug development, including all aspects of Medical Monitoring and study design/execution

  • 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.

  • Dermatologist, MD and board-certified or local equivalent

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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