Associate / Medical Director - Rheumatology (home-based, US)

Bring your Rheumatology experience and Lupus expertise to an Industry Leader, Parexel!

Building on our continued success, we are expanding our esteemed Medical Sciences Team and seeking an Associate / Medical Director to support the growth of our Global Immunology and Inflammation Therapeutic Franchise.

As an Associate / Medical Director, you will work closely with some of the best and brightest in the industry and assist our clients in the journey of getting new and innovative drug treatments into the hands of those who need them most. You will be a member of a fantastic and cohesive global team with great mentors and work with small to large clients across a broad spectrum of diseases.

Overall responsibilities of the Associate / Medical Director are to :

• Provide medical and safety monitoring for assigned projects
• Provide medical expertise and leadership to support business development and pre-award activities

Supporting Activities

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

Answer to site / study team questions relating to the study conduct or protocol

Review and sign off all data listings / tables, protocol deviations, datasets, for medical accuracy / consistency in accordance with study plans (Medical Monitoring Plan, Medical Data Review Plan, Data Surveillance Plan etc.

Deliver medical leadership to the project in close coordination with the Project Leader according to the role assigned either GLP or RLP by :

Timely identifying risks and challenges

Pro-actively proposing and / or delivering relevant actions contributing to the success of the study / project and risk mitigation

Creating a sense of urgency on any matters pertaining to safety of study participants and scientific integrity of the study

Attending and supporting any audits or inspections pertaining to assigned studies even if not directly involved in the audited activities

Participating in periodic rotas including night and weekend shifts e.g. for emergency medical contact and emergency unblinding phone requests for Parexel studies, as applicable and / or appropriate for the MD

Providing risk assessment of clinical trials for local sponsorship as needed with the support of the designated Senior Medical Director / Global Head of TA (as appropriate)

Pharmacovigilance Support

Business Development Support

Medical Expertise

Skills

Good knowledge of the drug development process including drug safety, preferred

Successful applicants will be

The ability to travel 15-20% is required

Internal candidates in the Americas who meet the Medical School requirements and who possess extensive experience treating rheumatology patients clinically and / or who possess extensive rheumatology clinical trial related experience will be considered for this home-based opportunity.

EEO Disclaimer

Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.

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