Position OverviewAn innovative biotechnology company is seeking an experienced Clinical Scientist to join its Clinical Development organization and support the advancement of novel therapies across oncology and immunology-focused disease areas. This individual will serve as a key member of the global clinical development team, partnering closely with Clinical Development physicians, Clinical Operations, Biometrics, Regulatory Affairs, Pharmacovigilance, Translational Science, and external partners to support the design, execution, analysis, and reporting of global clinical studies.
The successful candidate will bring strong clinical science expertise and experience supporting studies with sites across both the United States and Asia-Pacific (APAC) regions. As part of a lean and highly collaborative biotech environment, this individual must be comfortable wearing multiple hats, operating with a high degree of ownership, and contributing both strategically and tactically across development programs.
Working closely with the Medical Lead and broader study team, the Clinical Scientist will contribute to study design, protocol development, clinical data review, regulatory submissions, health authority interactions, and cross-functional decision-making throughout the clinical development lifecycle.
Key ResponsibilitiesClinical Development & Study Execution- Serve as the clinical science lead for assigned clinical studies, maintaining deep scientific and clinical knowledge within the relevant therapeutic areas.
- Contribute to study design discussions, protocol concepts, protocol development, protocol amendments, and related study documentation.
- Support global clinical trials involving sites across the United States and APAC, ensuring regional considerations are incorporated into study planning and execution.
- Provide clinical guidance on study conduct, protocol interpretation, and operational decision-making throughout the trial lifecycle.
- Partner with Clinical Operations and Medical Monitoring to support site selection, investigator engagement, protocol training, and study execution activities.
- Participate in investigator meetings and provide ongoing protocol training and support throughout study conduct.
Clinical Data Review & Analysis- Contribute to the development of Statistical Analysis Plans and review of Tables, Listings, and Figures.
- Provide clinical input into data collection strategies, data review plans, and clinical database design.
- Lead clinical data review activities, including identification of trends, emerging signals, protocol compliance issues, and data quality concerns.
- Collaborate with study teams, CRO partners, and site-facing personnel to resolve clinical data questions and support database lock activities.
- Present clinical data and study findings to internal leadership teams and external stakeholders as appropriate.
Safety & Risk Management- Collaborate closely with Pharmacovigilance, Medical Safety, and Medical Monitoring teams to support ongoing safety surveillance activities.
- Participate in safety review meetings and contribute to the interpretation of emerging safety data.
- Review safety narratives and ensure clinical documentation appropriately reflects evolving safety profiles.
- Support development and implementation of study-level risk management and mitigation strategies.
Regulatory & Scientific Contributions- Contribute to clinical sections of regulatory documents, including Investigator Brochures, IND/CTA submissions, briefing books, annual reports, responses to health authority questions, and other regulatory deliverables.
- Support interactions with global regulatory agencies and regional health authorities.
- Contribute to Clinical Study Reports and other key clinical development documents.
- Support disclosure activities, publication planning, abstracts, presentations, and manuscripts as appropriate.
Cross-Functional Leadership- Serve as a key clinical science partner across Clinical Development, Clinical Operations, Regulatory Affairs, Biometrics, Translational Science, Pharmacovigilance, and external vendors.
- Support Trial Master File (TMF) compliance and inspection readiness activities.
- Participate in audits and regulatory inspections, including preparation and response activities.
- Contribute to process improvements, operational efficiencies, and innovative approaches that enhance clinical trial execution.
- Thrive in a highly collaborative, fast-paced biotech environment where flexibility, initiative, and accountability are essential.
QualificationsRequired- Bachelor's degree in Life Sciences, Nursing, or a related scientific discipline; advanced degree (MS, PharmD, PhD, DNP, or equivalent) preferred.
- Minimum of 5 years of experience within biotechnology, pharmaceutical, or clinical research environments.
- Clinical Science experience supporting therapeutic development programs in oncology, immunology, autoimmune disease, or other related therapeutic areas.
- Experience supporting global clinical trials with sites in both the United States and APAC.
- Strong understanding of clinical trial design, study conduct, clinical data review, and regulatory requirements.
- Experience contributing to protocols, investigator brochures, clinical study reports, and regulatory submission documents.
- Demonstrated ability to analyze and interpret complex clinical data and communicate findings effectively.
- Experience working cross-functionally within matrixed global teams.
- Strong organizational skills and ability to manage multiple priorities simultaneously.
Preferred- Experience within a small or emerging biotechnology company.
- Experience supporting early-phase and proof-of-concept clinical studies.
- Experience supporting IND, CTA, and global regulatory submissions.
- Familiarity with U.S. and APAC regulatory environments and health authority interactions.
- Experience supporting multiple therapeutic areas across clinical development programs.
- Established relationships with key investigators and clinical research sites within relevant therapeutic areas.
