Biomedical Clinical Scientist in Camberley

The Biomedical Clinical Scientist is responsible for scientific oversight, data integrity and quality of clinical trial(s) in support of the development strategy for programs within the clinical development.

ROLE RESPONSIBILITIES

• Clinical scientist for assigned studies maintaining current scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment.
• Effectively partners with other clinical and medical colleagues, clinical operations and other functional lines for the successful implementation and execution of the clinical trial(s) within the assigned program.
• Responsible for scientific oversight, data integrity and quality of the clinical trial(s).
• Represents the study team in governance meetings and submissions, partners with/supports the clients Development lead/Medical Director regarding study and disease area strategy.
• Support authoring protocols, study level informed consent documents, and contributes to authoring of IBs, site training materials, clinical study reports, regulatory responses, and other clinical and regulatory documents; supports preparations for Health Authority meetings, participates as appropriate.
• Sets the clinical data review strategy and leads the team in the collection of quality data and review of emerging clinical data and trends; reviews and queries data; presents and discusses relevant data to appropriate teams, governance bodies, and other internal and external stakeholders.
• In close partnership with medically qualified colleague/s, analyzes the emerging safety profile of the drug, keeping the clinical and safety colleagues informed of changes in the safety profile as they occur in the assigned trial(s).
• Follows relevant SOPs and regulations, has an excellent understanding of and complies with applicable trainings, seeks opportunities to further improve quality and efficiency of clinical procedures; leads or actively participates in portfolio- and client level workgroups aimed at optimizing clinical development procedures; may be a subject matter expert for a relevant SOP or procedure.

QUALIFICATIONS

• Science degree (PhD, PharmD, or equivalent) and minimum of 7-year Clinical Research experience in Pharma-Biotech/CRO, OR BA/BS and minimum of 10-year Clinical Research experience in a similar role in industry/CRO.
• Clinical Research experience in the phase 3/pivotal space across various therapeutic areas, ideally on the side of the Pharma/Biotech and with a track record of successful regulatory submission, inspection, and regulatory approval.
• Excellent knowledge of clinical procedures, ICH guidelines, GCP and familiarity with FDA, EMA, and global regulations.
• Demonstrates a passion for helping patients with cancer and for the science of oncology, Inflammation and rare diseases.
• Proven analytical skills with the ability to work on large data sets.
• Effective communication, presentation, and organizational skills to ensure coordinated and timely delivery.
• Demonstrated scientific writing skills and excellent communication skills (written and spoken) in English; scientific productivity via publications, posters, abstracts and/or presentations.
• Embraces evolving technologies and adopts best practices aimed at improving the efficiency and quality of clinical development; proficient with basic IT; efficiently using a computer and telecommunications.
• Has a global collaborative perspective and mindset works well in a diverse team environment with colleagues from diverse cultures, backgrounds, and geographies both as a leader and a key contributor; works effectively with internal and external partners and investigators/medical professionals.
• Has extensive understanding of related disciplines, e.g., clinical operations, safety, biostatistics, regulatory, study management, pre-clinical, pharmacology, quality assurance.
• Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.