Global Program Director FSP EMEA

Work Schedule

Environmental Conditions

Job Description

Join Us as a Global Program Director Make an Impact at the Forefront of Innovation

The Global Clinical Operations Program Director (GPD) is a core global role within the Cell Therapy Clinical Operations (CTCO) funcation. The span of responsibilities is broad and may support one or several products depending on scope and complexity. The products supported will be in Phase 1-3 development but the program may include studies in all phases of drug development. On behalf of the Senior Global Clinical Operations Program Director (Sr GPD) the GPD provides strategic operational leadership and oversight of a suite of global clinical studies within a program covering all clinical program deliverables covering all clinical operations deliverables to scope quality budget time resource and risk ensuring new innovative design and delivery models are used appropriately. The role involves integrating strategy design feasibility and operational planning to produce business-focused clinical drug development programs that align with priorities and strategy. The GPD will develop the core clinical operations components for governance interactions with the oversight of the Sr GPD. The GPD may also act as the lead for cross-functional teams in delivery of clinical program team (CPT) activities assigned.

The GPD may provide project leadership for cross-functional clinical submission teams in support of regulatory marketing applications and post-registration product maintenance deliverables.

Additionally the GPD may lead or contribute to improvement and change projects within clinical operations and/or other business areas.

What Youll Do:

• Lead cross-functional teams of experts in the planning and delivery of a defined clinical program of studies and/or clinical activities to scope quality budget time planning the resource and managing risk
• Work closely with global study leaders to provide appropriate strategic oversight of a program of studies on behalf of Sr GPD and Clinical Program Team (CPT)
• Provide clinical operations expertise into the project (e.g. country selection feasibility operational input into design risks and external partner management) using new innovative design and delivery models to support governance interactions and project start-up.
• Responsible for providing clinical operations expertise into the development of new business case opportunities for review by governance bodies (cost timelines quality feasibility risk)
• On behalf of CPT responsible for managing clinical plans (cost FTEs and timelines) in business reporting system such as PLANIT
• Lead large or complex deliverables and the process to identify and solve/escalate operational issues and drive delivery to plan through internal or external partners (Alliance partners Clinical Research Organizations (CROs) vendors and Academic Research Organizations (AROs)).
• Act as the point of escalation for study teams for external partners for externally managed/outsourced studies as appropriate
• Responsible for leadership and program management of non-drug project work as assigned e.g. cross functional improvement/change initiatives
• Provide project leadership & management to cross functional Clinical Submission Teams in planning and execution of clinical contribution to Marketing Applications (aligning closely with other key contributors to submission package)
• Lead cross-functional teams in delivery of assigned clinical program team (CPT) activities
• Contribute to functional and cross-functional initiatives as Subject Matter Experts
• Mentor coach and support people development as appropriate.
• Actively participate in networking both within and outside the therapeutic area sharing best practises and lesson learnt
• Be an early adopter for new ways of working and act as ambassadors for change driving the implementation and utilization of new initiatives.

Education and Experience Requirements:

• University degree (or equivalent) preferably in medical or biological sciences or discipline associated with clinical research. Advanced degree is preferred.
• At least 10 years experience from within the pharmaceutical industry or similar large multinational organizations.
• Proven knowledge of project management tools and processes
• Proven experience in clinical development/drug development process in various phases of development and therapy areas.
• Proven ability to learn by working in multiple phases TAs and/or different development situations.

Knowledge Skills and Abilities:
Capable of working independently and exercising independent judgment to assess sponsor regulatory needs and work with project team members to producing compliant deliverables
Advanced broad understanding of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization licensing lifecycle management; expert knowledge of ICH and other global regulatory guidelines; in-depth understanding of a regulatory specialty areas such as preclinical clinical CMC publishing etc.
Advanced understanding of medical terminology statistical concepts and guidelines
Sharp analytical investigative and problem-solving skills
Advanced financial acumen with an in-depth of knowledge and practical application of budgeting forecasting and resource management
Recognized executive presence and consultation and presentation skills
Effective critical and strategic thinking skills that accounts for a broad impact
Project Lead:
Excellent customer service and relationship building skills and proven ability to provide strategic input into customer management in a complex environment
Excellent negotiation and marketing skills with ability to influence internal and external stakeholders and drive results
Superior judgment decision making escalation and risk management skills
Solution oriented with a demonstrated ability to drive innovation
Project Oversight:
Strong coaching and leadership skills
Excellent customer service relationship building and stakeholder management skills
Expert negotiation and marketing skills with ability to influence others and drive results
Superior judgment decision making escalation and risk management skills
Proven ability to drive corporate strategies to capture engage and retain repeat customers
People Manager:
Comprehensive coaching skills with a proven ability to have challenging conversations
Ability to identify and develop solutions to resolve training gaps for soft skill and technical development
Excellent performance stewardship with the ability to drive performance through metrics
Superior judgment decision making and problem-solving skills and proven ability to apply critical and analytical strategic thinking skills to drive development and retention of top performers
Proven leadership as a change champion
Ability to collaborate and foster accountability and excellence in a learning environment
Strong negotiation skills with ability to influence others and drive results
Proven ability to drive innovation in the development of talent strategies including ensuring the proper resources are allocated based on individual skills and abilities

Working Conditions and Environment:
Work is performed in an office/ laboratory and/or a clinical environment.
Exposure to biological fluids with potential exposure to infectious organisms.
Exposure to electrical office equipment.
Personal protective equipment required such as protective eyewear garments and gloves.

Why Join Us

When you join Thermo Fisher Scientific you become part of a global team that values passion innovation and a commitment to scientific excellence. Youll work in an environment where collaboration and development are part of the everyday experienceand where your contributions truly make a difference.

Apply today to help us deliver tomorrows breakthroughs.