Position Summary: The Clinical Scientist (CS), Associate Director provides scientific expertise to clinical studies and is responsible for clinical activities of assigned program. This role partners closely with the disease area (DA) heads, clinical trial physicians, and clinical leads, in developing the scientific and clinical strategy of assigned trials and/or programs.
As part of the clinical development team (CDT), the CS will use methodological, analytical and scientific expertise to develop study designs in different phases of clinical development. The role requires a well-organized, operationally focused individual with analytical skills and ability to deliver multiple tasks in a fast-paced environment. The role also requires leadership skills and collaboration skills to work closely with internal and external cross-functional teams.
This role can be based out of Parsippany, NJ or West Chester, PA. However, remote option may be considered for the right candidate meeting the requirements.
The role of the Clinical Scientist is to:
• Provide scientific expertise to clinical studies (eg: protocol, Key Results, Clinical Study Report)
• Contribute to planning and execution of trials with moderate supervision
• Support other clinical development activities (e.g. medical review and validation of clinical data, study risk assessment, quality review of data, signal assessment and such)
• Contribute to the Protocol concept sheet, final protocol and protocol amendments and the clinical study report for their studies
• Contribute to the clinical part of regulatory documents for their projects: e.g. Common Technical Document (CTD) for FDA & EMA submission, Briefing Books, and develop answers to questions from health authorities
• Provide appropriate scientific and clinical input and support for all activities related to clinical studies: e.g. clinical development team activities, investigators training, site feasibility assessment, patients eligibility, Medical Management Plan, clinical review of data, IDMC and IAC activities and more.
• Become the clinical expert and the point-person in the Clinical Study team related to clinical data, protocol procedures and scientific expertise, as appropriate.
Essential Duties & Responsibilities:
- Support the development of the protocol concept sheet, final protocol and protocol amendments.
- Contribute to the development, writing and review of the Clinical Development Plan (CDP).
- May lead or co-lead the CDT
- Provide appropriate scientific and clinical input and support for all activities related to clinical studies: e.g., clinical development team (CDT) activities, investigators training, site feasibility, patients eligibility, Medical Management Plan, clinical review of data, IDMC and IAC activities and more.
- Activities related to data generation and validation, including CRF (case report form) design, clinical data review/query resolution.
- Ensure continuous medical review of aggregated data during clinical trial conduct to identify trends and ensure quality data for database locks and interim data reviews
- Author or contribute to the development or review of medical related study documents (pre-defined protocol deviation list, the Informed Consent Form (ICF), narrative plan, study specific committee charter, etc)
- Support CRAs/CROs and internal Teva personnel on study protocol and related questions and serves as point of contact for managing/answering questions relating to trial procedures
- Engage with investigators, site staff, CROs, external development partners and site monitors to maintain enthusiasm and support enrollment for ongoing clinical studies
- Contribute to the processing of responses to medical questions raised by EC/IRBs, sites