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

In anticipation of future needs, we are seeking an additional Associate / Medical Director to join Parexel’s highly recognized Medical Sciences Team as we continue to grow 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

• Medical Support / Medical Monitoring for projects and studies contracted to Parexel

• 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 GLP or Regional Lead Physician RLP). Medical support includes but is not limited to the following:

• 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

• 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

Business Development Support

• 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 required

• Provide support for marketing activities as requested.

• Share sponsor insights and experiences (strategy, history, culture, priorities etc.) with peer and proposal teams

Medical Expertise

• Provide medical expertise to client as contracted across multiple channels and interactions such as:

--Consultancy on protocol development, drug development program etc.

--Medical review of various documents which might be audited by clients and regulatory agencies

More generally in any client interactions:

--Provide medical expertise and training to other Parexel personnel, as required.

--As appropriate write clear, concise medical documents

--Participate in activities to raise, coordinate and promote Parexel medical expertise both internally and externally including but not limited to internal therapeutic area meetings, trainings, white papers, slide sets, publications etc.

Skills

• Experience in clinical medicine (general or specialist qualifications) with a specialty Fellowship in a “therapeutic area” which is expected to be kept up-to-date

• Experience leading, mentoring and managing individuals/ a team, preferred, but not essential

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

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

• Excellent interpersonal skills including the ability to interact well with sponsor/client counterparts

• Excellent time management skills

• Client-focused approach to work

Successful applicants will be

• Medically qualified in an acknowledged medical school with completion of applicable clinical training (residency, internship, fellowship)

• Board certified/Board eligible in Rheumatology with extensive clinical experience

•Expertise in Osteoarthritis, SLE, vasculitis and gout are preferred

•Experienced as a Physician in Industry or as a clinical trial investigator with significant clinical research experience

The ability to travel 15-20% is required

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