Senior Director, Clinical Lead
KardiganAbout the role
About Us
Position Title: Senior Director, Clinical Lead
Department: Program Management
Reports To: Vice President, Global Program Head
Location: Princeton, NJ or South San Francisco, CA – On-site 4 days per week (Mon to Thurs)
Job Overview
The Senior Director, Clinical Lead will be expected to lead to the clinical strategy, planning and execution for key aspects of clinical development of the program. Direct responsibilities include working with Global project team to identify the best clinical study that will provide the target product profile that was developed, planning and executing all activities related to the clinical trials of the program and that may also include other activities such as publication of study results and presentations.
Essential Duties and Responsibilities
- Leads Clinical activities and is a key member of the Global Project Team.
- In charge of strategy and planning clinical development of phase 1 to phase 3 and post launch study protocols, amendments, and other clinical research related documents and study reports
- Provide clinical/scientific knowledge into the development, design, delivery, and communication of the global evidence generation plan
- Support cross-functional and global collaborations to integrate broad medical, scientific, and commercial input into the development program
- Interpret and communicate clinical trial data
- Takes primary responsibility, working with statisticians, modelers, and project team-members, for study data analysis and interpretation, reporting and communication
- Assists and provides oversight with the operational aspects of study conduct including site selection and activation, site investigator and staff training, budget planning and contract review
- Leads the clinical part of the submission dossier in regulatory filings dossiers, and updates, regulatory briefing documents, Investigational Brochures, and other relevant documentation
- Leads the clinical strategic planning, authoring and review of clinical parts of regulatory submissions and scientific data disclosures of the studies.
- Leads clinical medical re
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