Description
The Clinical Unit Cambridge (CUC) is GSK's MHRA-accredited early-phase clinical and translational medicine centre. The role will provide clinical leadership and management of a team of clinical research physicians as Principal Investigator (PI) for early-phase and experimental medicine studies.
Scientific and Clinical Leadership
- Provide medical and scientific expertise in the design, conduct, and interpretation of early-phase and experimental medicine studies.
- Act as co-Investigator or Principal Investigator on clinical pharmacology studies, experimental medicine studies, and FTIH trials.
- Perform study-specific diagnostic/therapeutic procedures and assist with their processing.
- Provide flexible support for clinical activities on an as-needed basis.
Principal Investigator Responsibilities
- Hold primary responsibility for medical safety and governance decisions on assigned studies.
- Serve as named PI for allocated clinical studies, accountable for participant safety, data integrity, and regulatory/GCP compliance.
- Develop strategies to anticipate and expertly manage medical safety issues.
- Lead the management of adverse events and medical emergencies.
Governance, Quality, and Compliance
- Ensure standards are maintained to enable the delivery of consistent high-quality and safe clinical trial conduct.
- Ensure compliance with acceptable medical standards and regulatory requirements.
- Accountable for responding to questions from RECs and regulatory authorities.
People Leadership and Development
- Provide line leadership and coaching to the team of clinical research physicians.
- Provide senior medical input into training of clinical staff.
- Aid the development of multidisciplinary staff through teaching, training, and supervision.
External Engagement and Reputation
- Represent GSK and Clinical Unit Cambridge in external scientific and clinical forums.
- Contribute to peer-reviewed publications and scientific communications.
Basic Qualifications:
- Medical degree with full GMC registration and licence.
- UK-trained doctors must have completed early Specialty or GP training.
- Non-UK-trained doctors must demonstrate clinical practice and get GMC registration.
- Industry or academic experience in early clinical development/experimental medicine.
Preferred Qualifications:
- A relevant post-graduate qualification in clinical pharmacology.
- Commitment to train toward and/or the Advanced Life Support Provider qualification.
- Strong verbal and written communication skills, ability to present and think critically.
Skills
- Clinical Development
- Drug Regulatory Affairs
- Evidence Based Decision Making
- Good Clinical Practice (GCP)
- Influencing Without Authority
- Learning Agility
- People Management
- Project Management
- Scientific Presentations
- Strategic Thinking