Director, Clinical Development

Assembly Biosciences, Inc.•South San Francisco, CA

9h•$289,000 - $312,600•Hybrid

About The Position

The Director, Clinical Development supports clinical study strategy and manages protocol development, execution, interactions with regulatory agencies and ethics committees, medical monitoring, and interpretation and presentation of clinical trials. The role focuses on the clinical development of novel drugs for viral diseases and other indications, requires an MD or equivalent medical degree, and serves as a lead medical monitor for company-sponsored studies. The Director designs and executes clinical development plans and protocols, collaborates with cross-functional teams throughout study implementation and delivery, provides real-time medical oversight, and conducts safety and laboratory data review. The position contributes to regulatory documents and filings, study risk management, safety surveillance, data analysis, scientific presentations, and engagement with investigators, key opinion leaders, and external experts. It also provides clinical guidance to internal teams and mentorship to clinical science and operations staff.

Requirements

MD, DO, or equivalent non-US 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 constructive scientific and clinical dialogue about 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 absorb new information quickly, gain command of 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 protocols for clinical trials in viral diseases and other indications.
Collaborate with functional teams during program implementation, study start-up, execution, closeout, data analysis and reporting, and support of 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 determinations, 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 monitoring guidelines across sites.
Perform ongoing medical review of safety and laboratory data, including target-organ safety signals, and 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 and study-level risk management and stopping or pausing criteria.
Provide complex scientific and clinical guidance to Clinical Trials Management, Biometrics, Regulatory, and Project Management to meet 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 to 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 document preparation and review, 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 virology, infectious diseases, and other relevant therapeutic areas.
Mentor and provide medical guidance to clinical science and clinical operations staff, as applicable.
Participate in evaluating business development opportunities.