Executive Medical Director- NY (Immunotherapy)
Works with the CMO, CSO and the CRO team members to develop and translate clinical strategy into trial options and protocols.
Performs clinical monitoring of one or more studies.
Conducts Medical Data Reviews (and data cleaning support as appropriate) of ongoing studies working with clinical operations and data management groups.
Addresses relevant clinical queries from study sites with documentation.
Identifies and builds relationships with investigators.
Contributes to Development Safety Update Reports (DSURs) and Periodic Safety Update Reports (PSURs).
Supports generation and coordination of clinical documents and deliverables in support of regulatory filings.
Responsible for the study timelines in a cross-functional matrix protocol team.
Responsible for the clinical development activities from site(s) initiation to study discontinuation.
Ensure that all the activities around study implementation are compliant with the GCP and regulatory requirements.
In collaboration with the CMO and CRO, designs and implements safety monitoring plans.
Interprets clinical data and makes appropriate decisions and recommendations.
Addresses relevant clinical queries from study sites; contributes to responses regarding study related HA and IRB questions.
Work with the Program Lead, team members and governance bodies to translate the strategy into trial options, protocols and action plans.
Work with the investigators to author clinical protocols and related documents (CRF, DRP), including Clinical study reports, clinical regulatory documents including integrated summaries and clinical overview.
Works consistently in a matrix environment.
Qualifications and Requirements
MD, PhD, Pharm D or other health related scientific field with a deep understanding of the clinical oncology and cell therapy, or equivalent therapy area knowledge
Understanding of the fundamentals of clinical development (e.g. from working as an investigator, working in an adjacent group in industry – e.g. monitoring)
Management of one or more uncomplicated studies and preparation of regulatory documents
Relevant clinical research experience (relevant academic research experience could potentially substitute)
Possesses a deep understanding of the fundamentals of protocol development and follow up, including but not limited to: Study monitoring, data collection and analysis, database cleaning and database lock
Possesses a history of handling multiple, complex, studies in parallel
Possesses a history of prior meaningful participation in regulatory submissions
Possesses a history of strong interaction with thought leaders
Proven team leadership capability
Performs as an individual contributor
Identifies when an issue is present and begins to address
Essential Leadership Behaviors
Identify and builds relationships with study investigators
Is seen and acts as the study expert by the site personnel
Ability to work and communicate efficiently with internal partners in the US for positions located outside the US
Identify and builds relationships with principal investigators
Identify Thought Leaders and use them for inputs in clinical strategy and protocol design
Maintain a strong medical/scientific reputation within the disease area
Contribute to interactions as a medical monitor on assigned clinical studies
Share specific clinical strategies with CMO and CSO
Study-specific clinical design and execution
Manage communication with key stakeholders (senior)
Candidates should email CV and cover letter to firstname.lastname@example.org