Senior Medical Director, Oncology

The Senior Medical Director is a recognized medical expert and leader with both specialized therapeutic expertise and broad 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 Senior Medical Director may represent GMS on cross-functional initiatives, lead initiatives within GMS, and where appropriate, manage a small team of physicians.

• Independently deliver all medical support required for successful delivery of the projects according to contracted agreement with the sponsor ...
• 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 and 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.
• Attend and support any audits or inspections pertaining to assigned studies even if not directly involved in the audited activities
• Participate 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
• Provide risk assessment of clinical trials for local sponsorship as needed
• 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
• Utilize metrics and key performance indicators to ensure high quality, cost effective delivery of medical services

• Actively listen to, solicit and address client feedback and suggestions regarding medical study-related activities in order to enhance client satisfaction
• Follow up 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.
• Integrate and put client interest and need first to build trust and demonstrate credibility, reliability, intimacy, and confidence
• Be a point of escalation for issues and arrange for resolution by effective interaction and negotiation with appropriate departments and senior leadership.
• Drive continuous improvements in meeting client expectations.

• Autonomously support Business Development as a core priority 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
• With the Section Head, develop a vision and make recommendations within own area of expertise to develop the size of Parexel activities in this area
• Coach and mentor junior team members on effective collaboration with clients as appropriate

• Work with Section Head to develop expertise in therapeutic area, including training of internal colleagues
• Provide senior/advanced medical expertise across multiple channels and interactions such as:
• Consultancy on protocol development or drug development program
• Medical review of various…