The Clinician is responsible for working collaboratively with the members of the development team (including a medically qualified individual) to establish the clinical development plan(s) for one or more compounds from lead development in discovery to Phase I-II clinical trials, and for designing/executing and reporting protocols for studies included in the development plan.
Depending on experience, may contribute to or be primarily responsible for formulation of clinical development plans. Contributes to or may independently design protocols, amendments and conduct data review, analysis and interpretation.
Consistent with Safety Review Plan, performs and documents regular review of individual subject safety data and performs review of cumulative safety data with the Safety Risk Lead or medically qualified individual. The specific components of safety data review are detailed in the Safety Data Review Guide – for Clinicians and SAF09 SOP (pharmacovigilance).
May contribute to or be primarily responsible for Go-No recommendations for the compound, including recommendation to advance to FIH after review of the preclinical package and involvement with transition and preparation to Phase III.
In conjunction with members of the development team may prepare strategy presentations, present and discuss data at relevant team, governance, external consultants, KOLs and potentially regulatory meetings as well as author clinical sections of regulatory documents (IB, Annual Reports, IND sections, CSR). Must have proven scientific writing skills and good communication skills.
Interface with discovery, safety sciences, statistics, PK/PD, marketing, regulatory, outcomes research, development operations, other members of the extended project team(s), internal governance, external experts and regulators.
In conjunction with study team is responsible for the on-time and within-budget execution of protocols.
May have functional responsibility for other clinicians assigned to the project and may supervise and develop other colleagues.
May act as clinical representative in in-licensing activities such as due diligence reviews and reports.
May transition early development clinical programs into late stage development.
Demonstrated experience with GCP and the ability to apply Pfizer policies and SOPs
Advanced scientific degree preferred (PhD, PharmD, MA); Degree in Life Sciences preferred. demonstrated experience in oncology drug development, early development preferred; familiarity with related disciplines (biostatistics, regulatory, pre-clinical pharmacology, pharmaceutical sciences); demonstrated scientific writing skills and good communication skills
10+ years in clinical development
Some travel may be required
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