Clinical Program Operations Lead (CPOC)
|Clinical Program Operations Lead (CPOC)|
|Europe; Middle East; Africa|
Lilly is a global healthcare leader that unites caring with discovery to make life better for people around the world. We were founded more than a century ago by a man committed to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work. Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism.
We have an exciting opportunity for a Clinical Program Operations Lead to join our team onsite at our research facility in Surrey.
This role will see you lead the creation and execution of the exploratory and biopharmaceutics clinical operational development plan at a molecule level, with technical leadership and operational oversight of clinical research trials within the development plan. You will be responsible for all aspects of global clinical trial operations within the plan, as the single operational point of contact from trial design through execution and close out, including co-ordination of right to operate documents, timeline creation and management, outsourcing plan, vendor management (including direct oversight of the operational deliverables), patient recruitment and retention and budget management.
Some of your Key Responsibilities will include:
Scientific and Therapeutic Area Expertise
•Consult with the project team for clinical and regulatory documents such as study protocols, Investigator Brochures (IBs), risk profiles, annual reports, briefing documents, New Drug Applications (NDAs), safety updates, clinical study reports (CSRs), abstracts, publications and manuscripts.
•Maintain expertise of meaningful disease states/targets, competitors, industry trends, and operational requirements to effectively plan in detail the studies and submissions
Clinical Project Management:
•Lead the implementation and integration of clinical project management processes and tools
•Collaborate with Third Party Organizations (TPOs) and cross-functional partners to execute the clinical strategy and key compound and trial deliverables on time and within budget
•Actively identify and communicate clinical risk assessment and mitigation/contingency plans within team and to functions and leadership
•Active participant in the selection process and provide day to day oversight for operational deliverables with external network of vendors to ensure delivery of the clinical project
•Serve as the central point of contact for the global clinical team, to resolve clinical implementation issues, lead risk assessments and contingency planning, and effective communication across and upward
Communication and Team Management:
•Champion a quality mindset across the clinical team by documenting key decisions, actions and key modifications in clinical scope, resources and timeline; ensuring accurate collection and communication of clinical metrics; ensuring archival of all relevant clinical information at the termination of a project and as appropriate throughout the project
•Build and develop key partnerships and interactions/integration with the clinical team, including leadership in governance forums (if applicable)
•Effectively and expertly communicate and influence at all levels across the organization clear and concise information to enable decision-making by team and governance/Stakeholders
•Collaborate effectively with all colleagues; able to work with, and deliver through others
•Navigate ambiguity and effective problem-solving/solution oriented skills to help develop and evaluate molecule level strategies from lead to legacy
•Develop spirit of learning agility, critical thinking and the ability to think differently to incorporate new learning49415BR
• Bachelor’s degree in a science related discipline from an accredited college or university.
• Relevant experience in the pharmaceutical industry in a role providing direct experience of leading clinical studies, ideally in exploratory and biopharmaceutics clinical development (5+ year experience preferred).
• Strong knowledge of regulations and guidelines that apply to the conduct of clinical trials
• Advanced scientific degree
• Proven capability to influence both internal and external environments appropriately and craft strong working relationships.
• Strong self-management, organizational and interpersonal skills with the capacity be flexible in varying matrixed environments, cross-culturally and with multiple customer groups.
• Demonstrated knowledge and experience with project management tools and processes, managing vendors and contract experience
• Established analytical skills; able to anticipate and recognize systemic problems, diagnose root causes and take corrective actions to prevent recurrence within the team.
• Excellent oral and written communication skills; ability to communicate clearly and with team members and leadership
• Validated experience of coaching and mentoring others.
Sound like you? Don’t delay, apply today by following the link.
|Embracing diversity is at the core of our long-held value of respect for people. It is the lens through which we understand and respond to the unique needs of the millions of individuals who depend on our medicines. For us, embracing diversity means understanding, respecting, and valuing differences, including but not limited to race, colour, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status. The greatest measure of our diversity efforts is our ability to attract and retain exceptional employees who feel comfortable in a culture that supports them being themselves.|