Study Clinician

Integrates scientific drug development knowledge to ensure excellence in development and translation of clinical research plans into efficiently delivered studies.

RESPONSIBILITIES:
Working collaboratively with the clinical leader, physician and members of the development team to establish the Clinical Development Plans for one or more compounds from lead development in Discovery to clinical trials.
Developing methodologies to support proof of pharmacology, proof of mechanism, proof of concept.
Provides input to the operational strategy and feasibility of clinical research studies, in partnership with development operations.
Actively participates in defining the key components of the clinical protocols.
Needs to have demonstrated experience with oncology clinical trials.
Responsible for the formulation of clinical development plans, trial design, protocols, amendments and conduct data review, analysis and interpretation.
Responsible for clinical research studies from trial design through clinical review, oversight and reporting.
Responsible for final recommendations to clinical development plans for one or more compounds, including the review of pre-clinical package after seeking appropriate input, review and endorsement from key stakeholders for go-no-go development decision criteria.
Prepare strategy decisions, present and discuss data at relevant team, governance, external consultants, and potentially regulatory meetings.
Lead efforts to author clinical sections of regulatory documents.
Consistent with Safety Review Plans, performs and documents regular review of individual subject safety data and performs review of cumulative safety data.
Lead efforts with discovery, safety sciences, statistics, marketing, regulatory, outcomes research, development operations and other members of the extended project teams at the study or compound level.
Acts as a liaison with internal groups including internal governance, commercial and external experts and potential regulators Responds and contributes to novel study designs
Maintains a high degree of awareness of the external environment and ensures external innovations in scientific aspects and operational delivery are applied to the Research portfolio
Analyze emerging study data to ensure appropriateness of the chosen subject population and proactively assesses the performance of techniques used for endpoint measures on an ongoing basis to ensure data quality
Builds relationships with external investigators to promote scientific discussions, clinical execution and avid interest in the company's success
Analyze emerging safety profile of the drug, keeping the physician clinician informed of changes in the safety profile as they occur in the assigned studies.
Must be fully knowledgeable about the safety profile of allocated drugs on which studies are being conducted, or which are called for in the protocol.
Involve in the transfer of novel techniques in partnership with other lines such as Development Operations so that they can be exported from specialized sites to in-house facilities or other investigators/vendors
May have functional responsibility for other clinicians assigned to the project and may supervise and develop other colleagues.

SKILLS:
MS Outlook