Role Description and Purpose:
A key member of the Blue Earth Diagnostics Research & Development (R&D) team, the Programme Leader will define development strategy and lead all activities on business-critical New Product Development programmes, ensuring the rapid generation of data to support regulatory approval in all key global markets, and Life Cycle Management. The Programme Leader will be a highly motivated individual, willing to take on a broad ranging role in a fast-paced environment as part of a global project team.
Main Responsibilities, Activities, Duties and Tasks
* Lead the Programme/Project Team from discovery or in-licensing to approval, through all phases of New Product Development.
* Provide oversight and assurance to the Blue Earth Diagnostics Executive Team of Programme activities and progress against the Programme objectives. In particular, the Programme Director is responsible for the following:
* Delivery of the Programme strategy.
* Operational oversight and project delivery, including Programme Gantt chart.
* Budget and resource management.
* Risk management.
* Lead the Programme Management Team in the Life Cycle Management of approved products.
* Collaborate, through close and frequent interactions, with other key functions including Medical, R&D, Regulatory Affairs, Quality Assurance and Commercial.
* As a representative of Blue Earth Diagnostics, responsible for clear and confident communication with external parties and effective internal and external stakeholder management.
* At all times to support the Blue Earth Diagnostics culture of compliance and to act in accordance with legal and regulatory guidance requirements and Blue Earth Diagnostics policies and procedures.
Education
* A degree level qualification in science or life science is preferred.
Professional Experience, Knowledge & Technical Skills
* Programme management experience, ideally to Director level, in research and development, preferably in a pharma or biotech company (or CRO); experience in oncology is preferable.
* Must have experience of working in and managing multi-functional Research & Development teams.
* Meticulous organisational capabilities, rigorous project & risk management abilities. Financial acumen to manage project resourcing & budgets.
* Must have a good understanding of the drug development process and the regulatory environment in the US and EU pertaining to drug development.
* A driven, results oriented manager with extensive people management experience and demonstrated ability to form, lead and manage teams effectively to achieve challenging goals.
* Ability to proactively identify issues and problems, assess risk and offer solutions and recommendations on Programme/Project issues. Able to make decisions under conditions of uncertainty.
* Solid knowledge of GMP, GLP and GCP regulations/requirements.
* An understanding of healthcare environment and knowledge of current competitive, commercial and political situations and their impact on BED strategies.
* Preferably a Project Management qualification such as PMP or Prince2.
* Research experience of radiopharmaceuticals preferred but not required.
Soft Skills – Company Values & Behaviours
* Excellent organisational skills, including multi-tasking, efficiency, punctuality, and Programme/Project management.
* A team player with strong coaching, facilitation and organisational skills, including experience in a cross-functional and highly matrixed organisations.
* Strong inter-personal and people skills, to include both oral and written communication skills, with an ability to influence, collaborate and build relationships in a global organisation, interacting with internal and external stakeholders daily.