Senior Clinical Scientist, Clinical Development

Senior Clinical Scientist, Clinical Development 

Our Client: Our client is developing a novel bispecific agonist engineered as a fusion protein for the treatment of viral infections. They are currently in a first-in-human Phase 1 study that includes participants with chronic hepatitis B (CHB).

Position Summary: The Senior Clinical Scientist serves as the lead clinical scientist on the first-in-human Phase 1 study and other studies across the program, providing scientific and clinical oversight to ensure high-quality trial conduct and data integrity. This role leads day-to-day medical monitoring activities in support of the Chief Medical Officer (CMO), collaborates closely with the Clinical Operations team, and partners cross-functionally both internally and externally with CROs to support protocol development, study execution, and delivery of clinical milestones. The successful candidate will author key study documents, review and analyze data directly, and oversee CRO deliverables.

Key Responsibilities:

• Serve as the lead clinical scientist providing scientific and clinical oversight throughout the trial lifecycle.
• Lead day-to-day medical monitoring activities in support of the CMO, including review and interpretation of clinical data and assessment of medical and protocol deviations, in collaboration with the clinical team and external parties (e.g., CRO).
• Prepare and present blinded and unblinded data packages for Safety Review Committee and dose-escalation meetings, including application of protocol stopping rules and sentinel dosing criteria.
• Integrate safety, pharmacokinetic (PK), pharmacodynamic (PD; e.g., interferon-stimulated gene and cytokine biomarkers), and immunogenicity (ADA/NAb) data to support dose-escalation and go/no-go decisions.
• Review and interpret interferon class-related safety signals, including cytopenias, flu-like symptoms, hepatic enzyme changes, thyroid function, and neuropsychiatric events, with CTCAE grading.
• Review HBV virologic and serologic data (HBV DNA, HBsAg, HBeAg) and, in collaboration with the CMO, distinguish on-treatment ALT flares from drug-induced hepatotoxicity.
• Contribute to expedited IND safety reporting in collaboration with the CMO and the pharmacovigilance vendor.
• Collaborate cross-functionally in the development of clinical protocols and related study documents, including but not limited to Investigator’s Brochures, development safety update reports (DSURs), informed consent forms (ICFs), protocol amendments, regulatory briefing documents, and Clinical Study Reports (CSRs).
• Support study planning, execution, and delivery of key milestones and deliverables.
• Oversee CRO clinical and data management deliverables, and participate in meetings with external vendors, including CRO, specialty labs (e.g., PK, biomarker, and immunogenicity labs), and consultants.
• Provide guidance to CRO and site personnel on the application of trial eligibility criteria.
• Participate in reviews of CRF design to ensure protocol-aligned data collection in collaboration with the Clinical Operations Lead and CRO Data Management and Programming. 
• Perform ongoing review of clinical and safety data outputs and listings, ensuring completeness, accuracy, and data integrity ahead of interim analyses and database lock.
• Support the CMO with study-required drug safety reviews, including causality and expectedness assessments and Sponsor review of SUSAR reports, and collaborate with Clinical Operations on safety reconciliation in preparation for database lock and other milestones.
• Participate in cross-functional discussions and decision-making, applying scientific judgment to support study goals and timelines.
• Contribute to publications and presentations.

Core Skills and Competencies

• Demonstrated ability to lead and manage scientific activities for development of clinical protocols (Phase 1 through Phase 3), including first-in-human and dose-escalation studies, and execution of a clinical development program.
• Strong knowledge of clinical research regulations and guidelines, including ICH GCP and IND safety reporting requirements.
• Proven ability to manage multiple competing priorities with strong planning, time management, and organizational skills.
• Excellent analytical skills, with the ability to critically interpret clinical trial data and synthesize clear, data-driven conclusions.
• Ability to effectively interact with stakeholders across departments, divisions, and the broader organization.
• Proactive mindset with strategic thinking and leadership focused on achieving study objectives.
• Skilled at influencing decisions across functional areas and with internal and external partners or vendors.
• Demonstrated ability to act independently and decisively when appropriate and required and to act effectively in a matrix environment.
• Strong problem-solving, prioritization, conflict resolution, and critical-thinking abilities.
• Excellent communication, technical writing, and presentation skills.

Education and Experience

Required:

• Advanced degree (e.g., MD, DO, PhD, or PharmD) 
• Minimum 5 years of industry (sponsor or CRO) experience conducting clinical trials, including direct experience with first-in-human or early-phase dose-escalation studies and activities from trial initiation through database lock and study report writing
• Experience with data review and visualization tools (e.g., Medidata Rave, Spotfire, JReview), MedDRA coding, CTCAE grading, and interpreting statistical output

Preferred:

• Infectious disease clinical development experience, particularly in chronic hepatitis B and/or respiratory viral infections
• Experience with interferons or other immunomodulatory biologics, including management of class-related safety events
• Experience interpreting PK, PD biomarker, and immunogenicity (ADA/NAb) data for biologics
• Experience with global clinical trials and in a small or emerging biotech setting