Clinical Program Lead

Here at Proclinical we are recruiting for a Clinical Program Lead at one of the largest global pharmaceutical companies at their site in Surrey. This company is committed to developing high-quality medicine to meet real world problems.

Job Responsibitlies:

• 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
• 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
• 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 learning

Skills and Requirements:

• Bachelor's degree in a science related discipline from an accredited college or university.
• At least 3-years' 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.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Matthew Pike on +44 207 4400 639 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.