Study Clinician

Is responsible for 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 clinical trials and the compounds through registration.
In collaboration with the clinical leader or designee, is responsible for developing methodologies to support proof of pharmacology, proof of mechanism and proof of concept studies.
In collaboration with the clinical leader or designee, is responsible for clinical research studies (methodology studies, biomarker studies, proof of mechanism studies, proof of concept studies, medical device studies etc.) from trial design (development of outline/core elements) through clinical review and oversight.
In collaboration with the clinical leader or designee, is 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. Supports efforts with discovery, safety sciences, statistics, marketing, regulatory, outcomes research, development operations and other members of the extended project team(s) at the study or compound level.
Responds and contributes to novel study designs
Leads efforts to author clinical protocols, authors sections of protocol related to conduct and execution of the study, coordinates contributions by other cross-functional areas and actively participates in defining the key components of the clinical protocols.
Leads efforts to author clinical sections of regulatory documents.
In collaboration with the clinical leader or designee, integrates scientific drug development knowledge to ensure excellence in development and translation of clinical research plans into efficiently delivered studies. In collaboration with the clinical leader or designee, prepares strategy decisions, presents and discusses data at relevant team, governance, external consultants and Data Monitoring
Analyzes 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
Consistent with Safety Review Plans and performs and documents regular review of individual subject safety data, performs review of cumulative safety data with the safety risk lead and monitoring.
Analyzes emerging safety profile of the drug
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
Builds relationships with external investigators to promote scientific discussions, clinical execution and avid interest in company's success. Provides input to the operational strategy and feasibility of clinical Research portfolio.
Provides input to the operational strategy and feasibility of clinical research studies, in partnership with development operations and alliance partners.
Involves in the transfer of novel techniques in partnership with other lines 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:

Outstanding verbal and written communication skills. MS Word Experience.