Clinical Trial Lead, Breast Program, Oncology Clinical Development

** The Grade/Level of the Role Will be Determined by the Qualifications and Experience of the Chosen Candidate **

JOB DESCRIPTION

• Work with the Program Lead or Senior Clinical Lead, and team members to translate the FDT strategy into protocols

• Clinical monitoring of one or more studies

• Data review and cleaning of ongoing studies

• Addresses relevant clinical queries from study sites

• Identify and builds relationships with investigators

• Contributes to DSURs and PSURs

• Supports generation and coordination of clinical documents and deliverables in support of regulatory filings

• Can work consistently in a matrix environment

• MD preferably with a background in clinical oncology; PhD, Pharm D or other health related scientific field with a deep understanding of the clinical oncology of the area of interest or equivalent therapy area knowledge.

• The position is based in the Princeton, NJ area.

JOB REQUIREMENTS

D07/D07M ROLE IMPERATIVES

• 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 GRS and GPV&E, designs and implements safety monitoring plans

• Interprets clinical data and makes appropriate decisions and recommendations to the Program Working Team sub team

• Addresses relevant clinical queries from study sites; contributes to responses regarding study related HA and IRB questions

D08/D08M ROLE IMPERATIVES

• D07 - D07M Job Requirements Plus:

• Work with the Program Lead, team members and governance bodies to translate the FDT strategy into protocols and action plans

• Work with the Program leads to author clinical protocols and related documents, including Clinical study reports, clinical regulatory documents including integrated summaries and clinical overview.

• Addresses relevant clinical queries from study sites; and authors responses to study related HA and IRB questions

D07/D07M 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

D08/D08M ESSENTIAL LEADERSHIP BEHAVIORS

• D07 - D07M Job Requirements Plus:

• 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 Health Authority interactions as a Medical Monitor on assigned clinical studies

• Share specific clinical strategies with other clinical teams

• Study-specific clinical design and execution

• Manage communication with key stakeholders (senior)

D07/D07M DESIRED BACKGROUND, KNOWLEDGE, AND EXPERIENCE

• 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

D08/D08M DESIRED BACKGROUND, KNOWLEDGE, AND EXPERIENCE

• D07 - D07M Job Requirements Plus:

• Has 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

• Has a history of handling multiple, complex, studies in parallel

• Has a history of prior meaningful participation in regulatory submissions

• Has a history of strong interaction with thought leaders

• Proven team leadership capability