Senior Medical Director, Therapeutic Area Lead - Women's Health

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

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.

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:
• 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

 

Client Relationship Building & Engagement:

• 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.

 

Business Development: 

• 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

 

Medical Expertise:

• 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 documents, which might be audited by clients and regulatory agencies 
• Write clear, concise medical documents including complex and strategic matters 
• Initiate and participate in activities to raise, coordinate and promote Parexel medical expertise both internally and externally including but not limited to internal therapeutic area meetings, training modules development, white papers, slide sets, publications etc. 
• Support patient centricity, diversity and inclusion in all projects

 

Departmental and Team Leadership, where applicable:

• Participate as requested in internal initiatives aiming at improving Parexel and GMS operational model 

• Contribute to the development of departmental capabilities including procedures and technology

• Actively work with Section Heads to ensure development and performance of self and team

• Create a culture of continuous improvement and lead team through change to deliver desired outcomes 

• Support timely assignment of MD to proposals, projects and studies 

• Manage the team members according to Parexel tools, guidelines and procedures 

• Guide, energize, motivate and coach team members to perform at the top of their abilities, in line with Parexel values and their organizational and personal career goals

• Support talent development of team and create environment and opportunities for each team member to thrive 

• Mentor/Manage team through clear and specific definition of accountabilities and expectations, assigning task/projects based on competencies and skills and helping staff to prioritize workload:

• to maintain adequate billability rate and efficient ratio between workload and personal life according to local guidelines

• to provide efficient support to BD activities including request for proposals, participation in bid pursuit meetings, capability meetings etc.

Recognize and reward colleague achievements

Skills:

• Excellent interpersonal skills including the ability to interact well with sponsor/client counterparts, internal colleagues and to manage and mentor staff
• Client-focused approach to work
• Excellent verbal and written medical and business communication skills
• Excellent standard of written and spoken English
• Excellent problem solving, risk assessment and decision-making skills at the department and enterprise level with the ability to analyze business needs and act decisively 
• A flexible attitude with respect to work assignments and new learning 
• Excellent time management skills
• 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

Knowledge and Experience: 

• Experience in clinical medicine (general or specialist qualifications) with a specialty in women's health (OB/GYN), which is expected to be kept up to date
• A strong background in clinical aspects of drug development, including all aspects of Medical Monitoring and study design/execution within a pharmaceutical, biotech or CRO environment
• Excellent knowledge of the drug development process including drug safety
• Clinical practice experience
• Understanding of the business model of a CRO
• Level of expertise is recognized internally and by others in the industry
• Experience in Pharmaceutical Medicine, preferred

 

Education:

• Medically qualified in an acknowledged medical school with completion of at least a basic training in clinical medicine (residency, internship)

 

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.