Study Clinician (non-MD)

California  ‐ Onsite
This project has been archived and is not accepting more applications.
Browse open projects on our job board.

Keywords

Description

Responsibilities
  • Integrates scientific drug development knowledge to ensure excellence in development and translation of clinical research plans into efficiently delivered studies.
  • Works 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 to Phase I-II clinical trials and biosimilarity registration.
  • Develops methodologies to support proof of pharmacology, proof of mechanism, proof of concept and biosimilarity studies.
  • 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.
  • Responsible for the formulation of clinical development plans, trial design, protocols, amendments and conduct data review, analysis and interpretation.
  • Responsible for clinical research studies (methodology studies, biomarker studies, proof of mechanism studies, proof of concept studies, biosimilarity, medical device studies etc) from trial design (development of outline/core elements) through clinical review, oversight and reporting.
  • Makes 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, prepares strategy decisions, presents and discusses data at relevant team, governance, external consultants, KOLs and potentially regulatory meetings.
  • Leads 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).
  • Leads 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.
  • 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
  • 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
  • Builds relationships with external investigators to promote scientific discussions, clinical execution and avid interest in the company's success
  • Analyzes 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.
  • Involves 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.
SKILLS

Advanced skills in MS Excel, MS Outlook, and MS Word desired.

Synectics is an Equal Opportunity Employer.
Start date
n.a
From
Synectics
Published at
23.03.2013
Project ID:
510003
Contract type
Freelance
To apply to this project you must log in.
Register