| Company Name: | Pfizer | Approximate Salary: | Not Specified |
| Location: | San Francisco, California | Country: | United States |
| Industry: | Pharmaceutical | Position type: | Full Time |
| Experience level: | 5+ years | Education level: | Doctorate Degree |
| ID | 15355 | Apply for this Job |
Role Description The Study Clinician integrates scientific knowledge and operational expertise to ensure excellence in development and translation of clinical research plans into efficiently delivered studies.
The 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 and the BioSimilars compounds through registration.
The Study Clinician is responsible for developing methodologies to support proof of pharmacology, proof of mechanism, proof of concept and biosimilarity studies.
The Study Clinician provides input to the operational strategy and feasibility of clinical research studies, in conjunction with development operations; accountable for final decision.
The Study Clinician actively participates in defining the key components of the clinical protocols.
Responsibilities
Technical responsibilities:
* Responsible for the formulation of clinical development plans, trial design, protocols, amendments and for conducting 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), clinical review, oversight and reporting.
* Responsible for forecasting and tracking the clinical budgets at the asset and study level.
* 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 or as delegated by the clinical leader. 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, clinical pharmacology, 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 and ensures these novel designs are optimized for operational effectiveness to ensure timely and cost effective delivery
* 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
Qualifications
* Established scientific basis, as evidenced by science degree (MD, PhD, PharmD) or 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
Click Here To Apply Now
0 Comments