Director, Clinical Development

Assembly Biosciences, Inc.•South San Francisco, CA

14h•Hybrid

About The Position

The Director, Clinical Development supports the development of clinical study strategy and manages protocol development, execution, interactions with regulatory agencies and ethics committees, medical monitoring, and interpretation and presentation of clinical trials for novel drugs targeting viral diseases and other indications. The role requires an MD or equivalent and serves as a lead medical monitor for company-sponsored studies. The position is based in South San Francisco, California, with a hybrid work arrangement. The Director designs and executes clinical development plans and protocols, collaborates with cross-functional teams through study implementation and conduct, and supports data analysis, reporting, and regulatory filings. The role provides medical oversight to investigators and sites, reviews safety and laboratory data, contributes to safety surveillance and risk management, oversees CRO medical monitors, and provides clinical guidance across internal functions. It also contributes to key study and regulatory documents, scientific presentations, external expert engagement, staff mentoring, and evaluation of business development opportunities. Assembly Bio is a biopharmaceutical company developing therapies for viral and liver diseases, including herpesviruses, hepatitis delta virus, cholestatic liver diseases, and hepatitis B virus. The company describes its culture as scientifically driven, ambitious, and collaborative, and states its commitment to diversity and inclusion and equal employment opportunity.

Requirements

MD, DO, or equivalent non-U.S. medical degree.
At least 5 years of clinical development experience in biotechnology, pharmaceutical, or CRO settings, or equivalent academic clinical research experience, including hands-on experience as a medical monitor or in clinical-trial safety review.
Clinical trial experience in an academic setting as an investigator or sub-investigator, or in industry as a director or medical monitor, 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 think analytically and strategically to formulate, develop, and execute clinical plans.
Experience engaging internal and external expert physicians, scientists, and other stakeholders in scientific and clinical dialogue on study design, conduct, and interpretation of results.
Experience working with CROs and other external resources, including oversight of CRO medical monitors.
Demonstrated ability to work in a team environment and thrive in a small-group setting requiring a high-energy, hands-on approach.
Ability to work with attention to detail in a time-sensitive environment.
Experience writing and editing scientific research reports.
Ability to quickly absorb new information, become familiar with relevant literature, and analyze and concisely summarize complex data and information.

Nice To Haves

Board certification or eligibility in Infectious Diseases, Gastroenterology/Hepatology, or Internal Medicine.
Direct experience in virology or infectious disease.
Experience interacting with regulatory agencies such as the FDA or EMA on clinical development programs.

Responsibilities

Design and execute clinical development plans and clinical trial protocols for viral diseases and other indications.
Collaborate with functional teams during program implementation, clinical study start-up, execution and closeout, data analysis and reporting, and support for NDA, MAA, and other regional filings.
Serve as medical monitor for company-sponsored clinical trials, providing real-time medical oversight to investigators and sites, including eligibility decisions, dose modifications, toxicity management, and responses to protocol-related medical queries.
Develop and maintain study-level Medical Monitoring Plans and medical data review plans; oversee CRO medical monitors and ensure consistent application of protocols and medical monitoring guidelines across sites.
Review safety and laboratory data on an ongoing basis, including target-organ safety signals such as ALT elevations, hepatitis flares, and potential drug-induced liver injury; partner with Drug Safety/Pharmacovigilance on SAE and SUSAR assessment, causality, and benefit-risk evaluation.
Participate in the Safety Review Team and serve as the clinical interface to independent Data Monitoring Committees; contribute to safety surveillance plans, study-level risk management, and stopping or pausing criteria.
Provide scientific and clinical guidance to Clinical Trials Management, Biometrics, Regulatory, and Project Management to support project deliverables and timelines.
Serve as a clinical point of contact for senior management and senior-level internal and external teams.
Provide medical and clinical input on study documents and data tools, including informed consent forms, case report forms, statistical analysis plans, and data edit checks.
Author key clinical documents, including protocols, clinical study reports, and regulatory filings.
Manage the clinical research component of regulatory documents, including 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 for medical monitoring activities.
Coordinate collection and assimilation of ongoing data for internal analysis and review, and coordinate preparation or review of data listings, summary tables, study results, and scientific presentations.
Present scientific and clinical study information at investigator, internal, and external meetings, and engage key opinion leaders and external experts in relevant therapeutic areas.
Mentor and provide medical guidance to clinical science and clinical operations staff, as applicable.
Participate in evaluating business development opportunities.