Director, Study Physician

This is a fully remote position, open to applicants in California.

📋 Description

• The study physician plays a vital role within the clinical team, offering medical expertise and oversight throughout the entire clinical trial process, from the initial study design to the final close-out.

• The medical monitor contributes actively to a cross-functional clinical team for each assigned study during the early development phase.

• Responsible for medical monitoring, safety activities, and the assessment of drug-induced safety findings, the medical monitor prioritizes patient safety for each trial assigned.

• Provides close supervision of external contract organizations responsible for site interactions, monitoring, data management, biostatistics, IRB interactions, central laboratory functions, clinical research budget negotiations, medical writing, pharmacovigilance, and other essential activities.

• Ensures that effective project plans are developed and operational for each trial, working proactively with the Clinical Trial Team (CTT) to prioritize tasks in alignment with applicable project plans, company standard operational procedures (SOPs), ICH/GCP guidelines, and regulatory requirements.

• Maintains oversight of study conduct at the study centers, including site selection, start-up, monitoring protocol adherence, Good Clinical Practices (GCP), applicable guidance, and study closure.

• Leads the sponsor study process, which includes conducting the Trial Kick-off meeting, organizing the trial master file (TMF), site selection, and finalizing site and vendor Clinical Trial Agreements and budgets.

• Reviews and approves site visit reports, ensuring timely tracking, follow-up, and resolution of site issues.

• Proactively manages project-level operational aspects of the Clinical Trial Team (CTT), including trial timeline, budget, resources, and vendors.

• Involves in vendor selection, project planning, trial budget and timeline management, quality standards, and risk mitigation strategies.

• Establishes and maintains positive working relationships with clinical study site personnel to guarantee adherence to protocols, Good Clinical Practice (GCP), provision of quality data, and compliance with study timelines.

• Oversees and supports Clinical Site Manager(s)/CRAs in the execution of trials.

• Monitors the quality of vendor deliverables, addresses quality issues with relevant team members, and identifies opportunities for enhancing training, execution, and quality control within the clinical team.

• Reviews and approves vendor invoices in collaboration with the accounting team to ensure timely investigator payments.

• Collaborates with the Director of Quality and Compliance to review and approve vendor responses to quality assurance audits, ensuring appropriateness, timeliness, and compliance with company SOPs and regulatory requirements.

• Ensures that all project-level study documentation is filed in the TMF per company SOPs and all regulatory requirements, providing oversight to the clinical team regarding TMF filing, maintenance, and archival procedures.

• Accountable for developing and managing the Clinical Operations budget.

• Reviews draft protocols and coordinates operations to meet protocol requirements.

• Oversees EDC/CTM entries and supplies appropriately quality-controlled study raw data to the Medical Writing team for report completion.

• Conducts quality control of clinical reports by utilizing protocol and procedural deviation reports, sample inventory, and medical writers.

• Ensures that study medications are received and dispensed promptly for assigned projects.

• Coordinates study monitor visits, including file reviews and follow-ups on findings or concerns.

⛳️ Requirements

• Proven experience in designing clinical trial plans, organizing clinical trials, and independently writing summary reports.

• Familiarity with research administration and experience with investigator-initiated trials.

• A solid understanding of federal regulations affecting clinical trials and medical research is preferred.

• Knowledge of experimental design and a fundamental understanding of statistics and statistical methods are required.

• Comprehensive knowledge and ability to apply applicable clinical research regulatory requirements, such as Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines.

• Strong therapeutic and protocol knowledge.

• Solid understanding of clinical research financial parameters along with project financial tracking and accounting methods.

• Excellent communication and interpersonal skills.

🏝️ Benefits

• Adagene is an equal opportunity employer committed to fostering diversity and inclusion.

• We strictly prohibit discrimination and harassment of any kind based on race, color, religion, sex, sexual orientation, gender identity, national origin, disability, pregnancy, veteran status, or any other legally protected characteristics as outlined by federal, state, or local laws.

• Adagene participates in the E-Verify program in select locations as required by law.

• We are dedicated to working with and providing reasonable accommodations to applicants with physical and mental disabilities.

• Adagene maintains a drug-free workplace.