An award winning pharmaceutical SME has an exciting opportunity for a Senior Project and Product Development Manager to join its team. Your role will be to lead and manage internal and external activities to ensure that projects are executed on time and to budget against agreed milestones. You must have extensive project management experience with significant years gained within a pharmaceutical, biotech or CRO company.
Responsibilities and Duties
- To assist with the coordination and oversight of cross-functional activities to support the Company portfolio of research and development programmes. All activities carried out within allocated time, and agreed costs and in accordance with quality requirements, Company SOPs, ICH/ GCP guidelines and local regulations.
- Maintain an understanding of related Company corporate objectives and key milestones.
- Preparation and maintenance of Target Product Profiles and Development Plans for assigned programme.
- Preparation and maintenance of programme and study level Gantt Charts.
- Preparation and management of programme and individual study budgets, for both forecasting and financial management of assigned studies/programme.
- Maintain documentation of programme and associated study activities, decisions, actions and risk assessments.
- Management and oversight of all aspects of development programmes in accordance with internal SOPs, ICH GCP, relevant guidelines and all applicable laws and regulations.
- Cross-functional coordination and oversight of all aspects of assigned programme to ensure agreed programme deliverables are met to the appropriate standards of quality eg manufacturing, pre-clinical and clinical.
- Set-up and management of CDMO, CRO and vendor contracts.
- Lead, plan and co-ordinate projects to agreed milestones.
- Manage activities to meet deliverables within agreed timelines and budget.
- Report project updates to the SVP Operations and to external parties as per specified timelines and format.
- Ensure external invoicing milestones are initiated on time and notified to Finance
- Raise purchase orders for external activities
- Track project progress and liaise with Finance.
- Organise vaccine batch review and shipments
- Champion the Company quality system including an ISO:13485 device regulations and health and safety best practices
- Develop & maintain strong commercial relationships with customers & suppliers
Qualifications and Skills
- BSc degree or higher in relevant sciences
- Extensive programme management experience with significant years within a pharmaceutical, biotech or CRO company
- Experience in oversight of external vendors (CROs, central labs, imaging vendors, etc.)
- Excellent written and verbal communication and presentation skills
- Excellent organisational and interpersonal skills
- Ability to manage multiple priorities within one or across different programmes
- Excellent working knowledge of GXP and current clinical trial legislation
- Thorough knowledge of the clinical development process, ideally from pre-clinical and first in human through to regulatory filing Market Authorisation
- Ability to create programme / study Gantt charts and along with good MSP skills
- Ability to manage and forecast programme and study budgets including assessing earnt value
- Ability to travel in the UK and abroad periodically if needed
- Ability to work in a dynamic small team environment
- Experience in biologics or vaccine product development is desirable
- Experience in regulatory documentation preparation is desirable
- Experience in pre-clinical and clinical programme management is desirable
- Experience in grant applications is desirable
- Experience in setup and management of Clinical Development Manufacturing Organisation
- Demonstrates personal drive and goal orientation.
- Self-motivated taking personal pride in delivering on personal and corporate objectives.
- Enthusiastic and flexible to change.
- Demonstrates strong organisational and prioritisation skills to manage a diverse workload.
- Able to interact with individuals at all levels of the organisation.
- A highly effective communicator, both orally and in writing with an eye for detail/ accuracy
- Reliable and trustworthy, able to work with minimal supervision
Experience in pre-clinical and clinical programme management is desirable
You must have the right to work in the UK. Learn more
- Agency: Cranleigh Scientific
- Reference: 7143
- Updated: 4th January 2022
- Expires: 1st February 2022