Clinical Scientist

The Clinical Research Scientist is a PhD-level scientist or clinical professional (such as a nurse practitioner or physician assistant) who plays a crucial role in Global Clinical Development, driving innovation in clinical programs. The CRS works closely with the Global Clinical Lead (GCL), synthesizing literature, preclinical data, regulatory insights from the FDA and EMA, clinical guidance, and clinical data to underpin the scientific rationale for clinical initiatives.

With strong analytical and critical thinking abilities, the CRS anticipates challenges and assesses data effectively, building scientific, translational, and clinical arguments that support program goals. This role involves presenting proposals to advisory boards, site initiations, and investigator meetings, and attending scientific and clinical conferences to maintain up-to-date knowledge in the field. The CRS collaborates across functions—including medical monitoring, clinical study operations, regulatory strategy, clinical operations, pharmacovigilance, and translational sciences—to ensure cohesive program execution. A strong communicator, the CRS can effectively convey complex information to governance teams and external advisors.

Key Responsibilities

1. Contribute to the development and execution of clinical research studies in compliance with regulatory standards, company policies, and department procedures.
2. Work closely with research physicians and other team members to ensure coordinated execution of study start-up activities, study oversight, and reporting.
3. Provide input into clinical strategy, including participation in and presentations at advisory boards.
4. Assist in conference coverage, tracking competitive intelligence, and identifying emerging topics in the clinical landscape.
5. Participate in clinical site and service vendor selection.
6. Contribute to study design and the development of clinical documents (e.g., investigator’s brochures, study protocols, informed consent forms, eCRFs, study manuals, clinical study reports, and regulatory submission documents).
7. Support regulatory writing tasks, ensuring accuracy and clarity in the preparation of submissions to regulatory authorities (e.g., clinical study reports, safety summaries, and responses to Health Authority inquiries).
8. Collaborate closely with the Global Clinical Lead.
9. May lead Taskforce initiatives focused on best practices or other strategic priorities.
10. Represent the Asset team at governance reviews or as a special topic presenter.
11. Collaborate with Medical Monitor (at the CRO), Regulatory Affairs, and Clinical Operations to address protocol queries from Health Authorities and Ethics Committees.
12. Participate in investigator meetings and foster investigator engagement, including protocol-related training as needed.
13. Provide clinical study or project status updates and help maintain strong collaborative relationships with Investigators, Key Opinion Leaders (KOLs), and external project team members.
14. Support the organization of specific project meetings (e.g., Advisory Board, Steering Committee, Data Safety Monitoring Board, and End of Cohort Meetings) alongside other functional leaders.
15. Coordinate closely with Clinical Operations for site start-ups, engagement, and recruitment efforts.
16. Work with the Medical Monitor and Medical Data Review teams (at CRO) to ensure effective medical monitoring, query management, eligibility review, and data quality.
17. Collaborate with pharmacovigilance physicians on safety issues to ensure alignment between the SAE and AE/laboratory databases.
18. Interface with external consultants on clinical matters as needed.
19. Reports to the Head of Clinical Development.

Required Qualifications

1. An advanced degree in a scientific discipline (e.g., Ph.D., Pharm.D., or clinical degrees such as NP/PA).
2. Critical thinking skills with strong analytical capabilities and a drive for innovation in oncology.
3. Demonstrated leadership skills with a collaborative approach to problem-solving.
4. Knowledge of Good Clinical Practices (GCP) and regulatory requirements for conducting high-quality oncology clinical trials is preferred.
5. Significant knowledge of oncology drug development is highly preferred.
6. Strong written and oral communication skills in English.
7. Proven experience in matrix team environments, working collaboratively across functional teams.
8. Experience in clinical protocol development, medical review, study oversight, trial management, and ensuring data quality and safety is strongly preferred.