Associate​/Medical Director - Rheumatology; home-based

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.

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

• Provide medical input into PV workflows and projects and participate in safety processing for studies including medical review of serious adverse events.
• Support regulatory safety reporting activities
• Ensure client needs and concerns are addressed to ensure customer satisfaction
• Actively listen to, solicit and address client feedback and suggestions regarding medical study-related activities in order to enhance client satisfaction
• Follow up sponsor satisfaction metrics pertaining to medical activities in assigned studies and propose /execute remediation plan in coordination with line manager and Project Leader in case of client dissatisfaction

• Support Business Development, as agreed with Line Manager, while adequately balancing time devoted to this activity with billable tasks
• In line with business development objectives, meet and attend phone conferences with clients to communicate and detail Parexel medical expertise and experience in a therapeutic area or in an indication
• Provide medical expertise/ leadership in Proposal Development Teams (PDTs) for client bid pursuit meetings
• Attend preparation meeting and Bid pursuit meetings as…