Head of Clinical Operations, Global Medical Affairs
- Experience Level
An exciting & critical position has opened with a well respected, medium sized global Pharma company.
The Head of Global Clinical Operations is a key leader with responsibility for executive oversight and overall management and conduct of all Medical affairs clinical studies and solicited programs.
Key areas responsibilities include
- Coordinate and lead the clinical operations organization, study planning, program oversight, financial oversight, vendor management, managing studies and programs timelines, ensuring compliance and adherence to best practices
- Provide expertise and strategic guidance
- Implement best practices and standards for study and program management in collaboration with other members of the clinical operations team, including establishment of SOPs
- Ensure that GMA clinical operations organization and infrastructure is fit for purpose
- Establish an operational model to ensure appropriate solicited programs operational oversight
- Be a member of MARB
- Represent/advocate for clinical operations needs/resources at a senior management level
- Other duties as assigned
- In collaboration with the GMA TA Heads, set up and regularly update an overall GMA Clinical studies plan
- To provide clinical and operational expertise/guidance for the design, implementation, execution follow-up and closing for any Global CSS, (from preparation & validation to full execution).
- Ensure quality, timely and efficient execution, within budget.
- Provide direct oversight and management of operations and personnel involved in clinical operations and other functional groups
- Provide operational and clinical expertise and strategic insights to evaluate new programs to be prioritized
- Develop clinical timelines and budget forecasts and be accountable for tracking and delivering accordingly
- Provide oversight of global CROs and vendors from service provider identification to selection to close of contracts
- Participate in developing and providing input to protocols and clinical study reports.
- Ensure that clinical studies and programs are properly resourced, managed and executed in accordance with timelines, regulations and good quality practices
- Plan clinical headcount and hiring needs to meet program workload
- Provide robust collaboration frameworkaround global CSS throughout medical affairs community
- To pro-actively act as contact point for internal functions within the company (e.g. TA Medical Directors, GMA Departments Heads, Drug Development, all other support function heads) and provide operational expertise to all of them.
- To participate to internal cross-functional task-forces
To provide expertise in GCP or RWE data generation regulations, or in specific therapeutic areas, in order to assess the operational pertinence of considered clinical study design
- To review, assess and provide clinical and operational expertise/guidance for the design, implementation, execution follow-up and closing for any Local Company Sponsored Studies (CSS)
- To provide operational expertise, assessment on the pertinence and robustness of studies (local CSS and ISS) i.e. study design, patient safety, recruitment criteria, ...
- Assess LMA capability/capacity to fully execute studies at all levels.
- Provide regular oversight of local studies execution
- To provide strategic input to the early access strategic plans
- To provide clinical and operational expertise/guidance for the design, implementation, execution follow-up and closing of early access programs, (from preparation & validation to full execution).
- To build a robust framework for patient support programs
- To establish an operational model for oversight, tracking and escalation of all solicited programs conducted by medical affairs
- Implement best practices and standards for study management in collaboration with other members of the clinical operations team
- Establish optimal processes to ensure efficient, agile, timely and compliant conduct of medical affairs studies , innovative data generation, and solicited programs for continuous improvement and adaptation to business model changes
- In collaboration with Medical Affairs Systems, ensure that there are systems that appropriately track the performance and compliance of medical affairs studies and solicited programs.
- MD, PhD, PharmD or Life sciences degree with significant and relevant experience (minimum of 15 years) of pharmaceutical drug development (Ph2, Ph3) of national and international programs and relevant experience (minimum of 10 years) in RWE/HEOR, NIS studies, including project management of national and international programs,
- Extensive experience and know-how (minimum of 7 years) in complex therapy areas such as oncology
- Passion to be the best and contribute as senior member of a growing company's leadership team.
- Self-motivated and with a strong collaborative work ethic.
- Intimate knowledge of Good Clinical Practice (GCP) and RWE data generation regulations.
- Superior communication, strategic, interpersonal and negotiating skills.
- Ability to proactively predict issues and solve problems.
- Ability to drive decision-making within a multi-disciplinary, multi-regional, matrix teams.
- Diplomacy, advanced negotiation and positive influencing and motivational abilities across multinational business cultures.
- Demonstrated scientific/technical leadership, and strategic planning and implementation
- Ability to manage through ambiguity and uncertainty. Ability to think laterally.
- Excellent planning and prioritization skills
- Capable of building organizations and developing talent. Demonstrated experience in managing global, cross-functional teams. Proven leadership skills in managing teams of culturally diverse backgrounds.
- Experience of managing and developing relationships with Service Providers,
- Good business instincts and a high ethical standard.
- English proficiency and other languages an advantage.
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