• Acts as a liaison with internal groups including internal governance, commercial and external experts and potential regulators
• 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 and the Biosimilars 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.
• In collaboration with the clinical leader or designee, supports 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.
• 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 including the Investigator Brochure, Annual Reports, IND sections.
• 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, KOLs or Steering Committee and potentially regulatory meetings.
• 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 related SOPs, performs and documents regular review of individual subject safety data, performs review of cumulative safety data with the safety risk lead and monitoring physician (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.
• Analyzes emerging safety profile of the drug, keeping 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.
• In collaboration with the clinical leader, is responsible for the formulation of clinical development plans, trial design, protocols, amendments and conduct data review, analysis and interpretation.
• 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
• Provides input to the operational strategy and feasibility of clinical research studies, in partner