Director, Clinical Development

Assembly Biosciences, Inc.

. Design and execute clinical development plans and protocols for clinical trials in viral diseases and other indications .

Posted 11/10/2026full-timeSouth San Francisco • California • United StatesLead💰 $289,000 - $312,600 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical development, including designing and executing clinical trial protocols, medical monitoring, and regulatory submissions. Proficient in engaging with key stakeholders and ensuring compliance with GCP and FDA regulations.

Highest-signal resume keywords

Clinical Development PlanningMedical MonitoringRegulatory SubmissionsInfectious Diseases ExpertiseGCP Compliance

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Hard Skills

Clinical Trial DesignSafety ReviewData AnalysisStatistical AnalysisAdverse Event ManagementProtocol WritingMedical Data ReviewRisk ManagementPatient Care ExperienceCRO Oversight

Soft Skills

Team CollaborationCommunicationMentoringAnalytical ThinkingStakeholder Engagement

Certifications & Qualifications

MD or DOBoard Certification in Infectious DiseasesBoard Certification in Gastroenterology/HepatologyBoard Certification in Internal Medicine

Industry Keywords

BiotechnologyPharmaceuticalCROVirologyInfectious DiseasesFDAEMAGCPICHClinical Research

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Design and execute clinical development plans and protocols for clinical trials in viral diseases and other indications
Collaborate with functional teams during program implementation, study start-up, execution, closeout, data analysis/reporting, and NDA/MAA/ROW filings
Serve as medical monitor for company-sponsored clinical trials, providing real-time medical oversight to investigators and sites
Develop and maintain study-level Medical Monitoring Plans and medical data review plans
Oversee CRO medical monitors and ensure consistent application of protocols and monitoring guidelines
Perform ongoing medical review of safety and laboratory data, including target-organ safety signals
Partner with Drug Safety/Pharmacovigilance on SAE and SUSAR assessment, causality, and benefit-risk evaluation
Participate in the Safety Review Team and serve as clinical interface to independent Data Monitoring Committees
Contribute to safety surveillance plans, study-level risk management, and stopping/pausing criteria
Provide scientific and clinical guidance to Clinical Trials Management, Biometrics, Regulatory, and Project Management
Serve as clinical point of contact for senior management and senior-level internal and external teams
Provide medical and clinical input to informed consent forms, case report forms, statistical analysis plans, and data edit checks
Author protocols, clinical study reports, and regulatory filings
Manage clinical research components of regulatory documents, IND annual reports/DSURs, IND safety reports, Investigator Brochures, and development plans
Support responses to health authority and ethics committee/IRB questions and inspection readiness
Coordinate ongoing data collection, internal analysis, data listings, summary tables, study results, and scientific presentations
Present scientific and clinical study information at investigator, internal, and external meetings
Engage key opinion leaders and external experts in virology, infectious diseases, and relevant therapeutic areas
Mentor and provide medical guidance to clinical science and clinical operations staff
Participate in evaluating business development opportunities

Requirements

What you’ll need

MD (or DO, or an equivalent non-US medical degree) is required
Minimum of 5 years of experience in clinical development in the biotechnology, pharmaceutical, or CRO setting, or equivalent academic clinical research experience
Hands-on experience as a medical monitor or in safety review of clinical trials
Board certification or eligibility in Infectious Diseases, Gastroenterology/Hepatology, or Internal Medicine preferred
Direct experience in virology / infectious disease considered uniquely qualified
Clinical trial experience in an academic setting or industry, with hands-on patient care and clinical practice experience
Thorough understanding of GCP and familiarity with relevant FDA and ICH guidance, including adverse event management and safety reporting requirements
Working knowledge of statistics as applied to clinical trial design and analysis
Ability to formulate, develop, and execute clinical plans
Experience engaging internal and external expert physicians, scientists, and key stakeholders around study design, study conduct, and interpretation of clinical results
Experience working with CROs and other external resources, including oversight of CRO medical monitors
Experience interacting with regulatory agencies such as FDA and EMA preferred
Demonstrated ability to work in a team environment and in a time-sensitive setting
Experience writing and editing scientific research reports
Ability to absorb new information, analyze and concisely summarize complex data and information