Director, Clinical Development

Summary

This is an opportunity to work in a dynamic role, supporting the development of clinical study strategy and managing the subsequent protocol development, execution, interaction with regulatory agencies and ethics committees, medical monitoring, interpretation and presentation of clinical trials associated with the clinical development of novel and innovative drugs for viral diseases and other indications. This role requires an MD and serves as a lead medical monitor for company-sponsored studies.

Specific Responsibilities

• Designing and executing clinical development plans and protocols for clinical trials in viral diseases and other indications, including collaborating with the functional team during program implementation, clinical study start-up/execution/close out, data analysis/reporting and support of NDA/MAA/ROW filings
• Serving as the medical monitor for company-sponsored clinical trials, providing real-time medical oversight to investigators and sites, including eligibility determinations, dose modification and toxicity management, and responses to protocol-related medical queries
• Developing and maintaining study-level Medical Monitoring Plans and medical data review plans; overseeing CRO medical monitors and ensuring consistent application of protocol and medical monitoring guidelines across sites
• Performing ongoing medical review of safety and laboratory data, including target-organ safety signals (e.g., hepatic signals such as ALT elevations, hepatitis flares, and drug-induced liver injury assessment), and partner with Drug Safety/Pharmacovigilance on SAE and SUSAR assessment, causality, and benefit-risk evaluation
• Participating in the Safety Review Team and serving as the clinical interface to independent Data Monitoring Committees; contributing to the safety surveillance plan and to study-level risk management and stopping/pausing criteria
• Providing high level, complex scientific and clinical guidance to Clinical Trials Management, Biometrics, Regulatory and Project Management to meet project deliverables and timelines
• Serving as a clinical point of contact for senior management and senior level teams, both internally and externally
• Providing medical and clinical input to key study documents and data tools, including informed consent forms, case report forms, statistical analysis plans, and data edit checks
• Authorship of key clinical documents, including protocols, clinical study reports, and regulatory filings
• Managing the clinical research component in the preparation/review of regulatory documents, IND annual reports/DSURs, IND safety reports, Investigator Brochures, and development plans; supporting responses to health authority and ethics committee/IRB questions and support inspection readiness for medical monitoring activities
• Coordinating the collection and assimilation of ongoing data for internal analysis and review, and coordinating the preparation and/or review of data listings, summary tables, study results and scientific presentations
• Presenting scientific and clinical study information at investigator meetings, internal meetings, and external meetings, and engage key opinion leaders and external experts in virology, infectious diseases, and other relevant therapeutic areas
• Mentoring and providing medical guidance to clinical science and clinical operations staff, as applicable
• Participating in the evaluation of business development opportunities

Qualifications

• 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, including hands-on experience as a medical monitor or in safety review of clinical trials
• Preferred: board certification or eligibility in Infectious Diseases, Gastroenterology/Hepatology, or Internal Medicine; direct experience in virology / infectious disease will be considered uniquely qualified
• Clinical trial experience either in the 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
• Experienced with engaging internal and external expert physicians, scientists, and other key stakeholders in constructive scientific and clinical dialog around study design, study conduct, and interpretation of clinical results
• Experience working with CROs and other external resources, including oversight of CRO medical monitors
• Preferred: experience interacting with regulatory agencies (e.g., FDA, EMA) on clinical development programs
• Demonstrated ability to work in a team environment. Able to thrive in a small group setting that requires a high energy, hands-on attitude
• Must be capable of working with attention to detail in a time sensitive environment
• Experience in writing and editing scientific research reports
• The ability to absorb new information quickly and gain command of relevant literature along with the skills to analyze and concisely summarize complex data and information