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Global Head of Clinical Development
vor 4 Wochen
Who we are
Vectura Fertin Pharma’s ambition is to become a market-leading wellness and healthcare business. Formed in March 2022, the business brings together two unique organizations: Vectura, experts in inhalation technology and Fertin Pharma, experts in oral and intra-oral delivery systems.
We are driven by the exciting and unique goal of addressing unmet patient and consumer needs by revitalizing, repurposing, and reimagining existing therapies to better serve people in taking care of their health and wellbeing.
What we will deliver
We focus on the development of a proprietary pipeline of wellness and healthcare products, with a specific focus on highly differentiated products that address unmet medical and consumer needs.
By leveraging our unique and enabling R&D capabilities, we are building a pipeline that includes inhalable medicines, nicotine replacement therapies (NRT), and consumer wellness products.
About the role
As Global Head of Clinical Operations, VP you will be responsible to lead and oversee the clinical operations team and work closely with the Clinical Development Sciences VP and medical directors. Your will be responsible for ensuring operational excellence, study design input, optimization of execution timelines, budget management and CRO / vendor oversight supporting the whole VFPh product portfolio.
Core responsibilities:
• Leadership, oversight, and strategic direction for the efficient operational planning and execution of all global clinical development programs
• Clinical study budget accountability and vendor management
• Strategic input into Clinical Development Plans to ensure successful implementation and achievement of corporate & team goals
• Build, direct, develop and support Global Clinical Operations department
• Represent Global Clinical Operations in decision making bodies (Categories, DWG, VFP LT, IBP).
• Accountable for Clinical Operations and deliverables linked to new product developments as well as management of lifecycle activities.
• Oversee authority interactions in close collaboration with the Regulatory function to plan & deliver timely trial operations for all products and in support of establishing evidence for drug files and commercial activities.
• Leads, participates, supports as appropriate, internal and external audits and inspections of the company for relevant clinical operations scope.
• Provides trial expert advice to senior management from early ideation stages to key investment decision and/or performs due diligence activities on trial programs part of M&A assessments
• Influence, lead and manage Global Clinical Operations team thus ensuring oversight of planning, budgeting, and executing the study management process.
• Develop and maintain an excellent team spirit and high motivation within Clinical Operations
• Implements performance excellence by identifying best practices, using of appropriate tools, offering of appropriate training, building measurement systems and thus continuously improving operational efficiency.
• Forecast, implement, and manage resource strategies with internal and external groups for global drug development programs,
• Strategically lead CROs/vendors identification, selection and management
• Develop, lead and implement global quality initiatives to ensure regulatory / legal compliance and collaborate on development of operational policies and procedures as part of intra-company matrix.
• Develop, prioritize, and meet measurable short- and long-term objectives for global clinical research programs; estimating budgets and resources for planned clinical programs; delivering programs to pre-determined budgets, standards, and timelines.
• Represent Global Clinical Operations as part of Corporate Leadership and Strategy Teams, ensure effective representation by direct reports on teams/groups.
• Maintain excellent relationships with partners and suppliers in clinical development programs to optimize delivery.
• Collaborate with other departments as needed and maintain excellent relationships.
• Awareness of overall developments in the field of clinical research and specialized therapeutic areas
Key measures of success:
• Quality and timely planning and execution of assigned clinical programs
• Oversight over studies budget management
• Cross-functional collaboration with functions, categories and and project leads
• Efficient functioning of the Global Clinical Operations department
Role Requirements:
• Advanced scientific degree (ie PharmD, PhD, MD)
• Significant experience in the pharmaceutical industry, including global drug development across all phases, and in multiple therapeutic areas, with a successful track record
• Detailed experience in leading a Global Clinical Operations team
• Excellent knowledge of the drug development process, clinical development planning and execution, and ICH GCP requirements
• Experience working with major regulator (FDA, EMA) requirements and expectations, incl IND, CTA, NDA submissions.
• Good understanding of clinical research methodologies, and regulatory requirements
• Financial acumen in creating and managing clinical study budgets
• Proven track record in successfully managing CROs and vendors throughout the entire clinical study life cycle
• Possess an inspection readiness culture and is able to interact with PIs/KOLs in North America and Europe – broadly.
• Strategic and entrepreneurial thinking, ability to interact productively in the best interest of the company
• Excellent negotiation skills and experienced in contracts negotiation
• The candidate should have both strong presentation and outstanding communication skills in the context of a publicly listed global business with excellent language skills in English
• Proven capabilities working in a matrix organization
• Team building and team-oriented approach
• High ethical standards and integrity
Why Join Us?
We are bound by our shared passion for making a positive impact on the lives of consumers and patients. Vectura Fertin Pharma is a place where you can help shape the future of healthcare, where we collaborate, support, and inspire each other to achieve the best outcomes.
As a growing business, we can offer a wealth of opportunity to develop your career both locally and in international settings. We embrace hybrid and flexible working and are centered on delivering a ‘purpose-driven’ experience for all our employees.
Be part of an inclusive, diverse culture, where everyone’s contribution is respected; collaborate with some of the world’s best people and feel like you belong.
Apply
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