We currently have an opening for a Clinical Development Medical Lead in our office. This role will be responsible for providing leadership of clinical development programs, and for the design, execution, and analysis of clinical trials, as well as for supporting Medical Monitoring activities across trials.
• Leads project team strategy, scope, complexity, size, and deliverables, overseeing the development strategy, clinical development plan.
• Leads the design, data collection, review, execution of clinical studies in support of product development, ensuring rigorous and compliant study conduct with current health authority regulations.
• Directs, designs, authors and reviews clinical trial protocols, protocol amendments, informed consent documents, investigator brochures, CRFs, monitoring plans, data and statistical analysis plans, etc.
• Authors and reviews sections of clinical study reports and regulatory submission documents, such as, INDs, CTAs, NDAs, MAAs, regulatory agency briefing packages, etc.
• Supports the review, analysis and interpretation of clinical-medical safety and efficacy trial data, including Adverse and Serious Adverse Events, clinical laboratory data, and other technical examinations
• Responsible for the scientific execution as required for the initiation, conduct and medical monitoring of Phase 1-4 clinical trials
• Prepares, presents, and defends complex aspects of protocol design and/or medical study data at internal meetings or investigator meetings
• Actively engages in the planning, preparation and participation of regulatory meetings, e.g., Pre-IND-, End-of-Phase 2 meeting, or other regulatory meetings
• Collaborates with external stakeholders such as study investigators and their staff, Key Opinion Leaders, CROs and vendors during all phases of the clinical trial and program.
• Prepares and reviews draft abstracts, presentations, posters, and manuscripts for publication in consultation with other team members/collaborators
Required Education and Experience:
• Requires an MD degree with a minimum of 3 or more years of biotech or pharmaceutical experience in neuropsychiatry drug development. Dementia, schizophrenia, bipolar disorders, psychosis, depression, or delirium experience is highly preferred. Medical/scientific background in Psychiatry is required.
• Ability to develop and conduct complex clinical research programs independently. Has advanced the development strategy of clinical programs including pivotal clinical trials (Phase I-III).
• Will be able to develop, author and review Clinical trial protocols, Informed Consent forms, CRFs, Investigator brochures, Clinical study reports, Data Monitoring plans, Safety Monitoring CRFs, Investigator brochures, Clinical study reports, Data Monitoring plans, Safety Monitoring Plans, Development Safety Update Reports, and other regulatory documents
• Has expertise in the review, analysis and interpretation of clinical-medical safety and efficacy trial data, including Adverse and Serious Adverse Events, clinical laboratory data, and other technical examinations
• Will be able to evaluate safety events (e.g., SUSARs, laboratory observation, etc.) and analyze in conjunction with similar events across clinical trials and programs. Will be able to closely collaborate with the Safety and Pharmacovigilance group and Medical Monitors at the CRO.
• Deep understanding of Good Clinical Practices (GCPs) is necessary. Has successfully conducted clinical trials in a GCP/ICH compliant environment
• Has demonstrated the ability to analyze, interpret, and present complex scientific clinical data to both subject matter (e.g. key opinion leaders) and non-subject matter experts and is able to draw medical and scientific conclusions
• Has demonstrated understanding of biostatistics, trial planning and sample size generation in collaboration with the biometrics group
• Has demonstrated scientific expertise in the presentation and publication process. A track record of publishing peer-reviewed scientific data, e.g., posters, oral presentations, review articles, and manuscripts is definite plus.
• Can work well in a cross-functional team environment which includes representatives of Clinical Operations, Regulatory, Project Management, Clinical Pharmacology, Clinical supplies, Data Management, CROs, etc.
• Has good ability to present and communicate medical or scientific clinical data in a clear and concise manner
• Proven leadership skills and ability to successfully guide and influence cross-functional teams.
• Has demonstrated ability to work independently and meet deadlines in a dynamic, fast-pace work environment and deliver the highest standard of quality work.
• Excellent verbal and written skills along with the ability to work collaboratively in a dynamic and creative environment.