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Job Description:
The Non-MD/Study Clinician integrates scientific drug development knowledge to ensure excellence in development and translation of clinical research plans into efficiently delivered studies.
The Non-MD/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 Discovery to Phase I-II clinical trials.
The Non-MD/Study Clinician is responsible for developing methodologies to support proof of pharmacology, proof of mechanism, proof of concept.
The Non-MD/Study Clinician provides input to the operational strategy and feasibility of clinical research studies, in partnership with development operations.
The Non-MD/Study Clinician actively participates in defining the key components of the clinical protocols.
The Non-MD/Study Clinician 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.
Major Job Responsibilities:
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, 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.
In collaboration with the clinical leader, prepare strategy decisions, present and discuss data at relevant team, governance, external consultants, KOLs and potentially regulatory meetings.
Lead efforts to author clinical sections of regulatory documents including the Investigator Brochure, Annual Reports, IND sections.
Consistent with Safety Review Plans, performs and documents regular review of individual subject safety data and performs review of cumulative safety data with the safety risk lead (as delegated by the clinical lead). The specific components of safety data review are detailed in the Safety Data Review Guide - for Clinicians and SAF09 SOP.
Lead efforts with discovery, safety sciences, statistics, PK/PD, marketing, regulatory, outcomes research, development operations and other members of the extended project team(s) at the study or compound level.
Acts as a liaison with internal groups including internal governance, commercial and external experts and potential regulators.
Scope of Work:
Responds and contributes to Client 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 Pharmaceutical'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 study(ies). 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 Client 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.
Required Experience:
May have functional responsibility for other clinicians assigned to the project and may supervise and develop other colleagues
Training, Education, and Experience Preferred:
Established scientific basis, as evidenced by science degree (MD, PhD, PharmD) or Master degree with demonstrated depth and breadth of knowledge and experience in clinical research in academic, clinical practice or industry setting
Extensive understanding of related disciplines (biostatistics, regulatory, pre-clinical, pharmacology, pharmaceutical sciences)
Demonstrated scientific productivity (publications, abstracts, etc.)
Demonstrated scientific writing skills and good communication skills. Will consider a good candidate with both clinical experience and clinical operational experience.

Regards,

Anuj Mehta

973-967-3402