Scientific Programme Leader.

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.