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ROLE SUMMARYThe Assoc Director MD Clinician in Digital Medicine & Translational Imaging plays a key role in the oversight, safety monitoring, design, execution, and reporting of internal clinical studies that will be run at the Pfizer Innovation Research (PfIRe) Laboratory in Pfizer's Kendall Square facility (Cambridge, MA). The MD Clinician is also responsible for working collaboratively with members of development teams (including medically qualified individuals) to establish clinical development plan(s) for one or more compounds from lead development in discovery to Phase I-IV clinical trials, and for designing/executing and reporting protocols included in the development plan.Digital Medicine is an industry-leading mobile/digital technology initiative striving to utilize digital continuous remote monitoring of patients' symptoms as novel endpoints for disease diagnosis, physical function measurements, and health state assessment. The PfIRe lab is a clinical research unit outfitted with state of the art technology where studies may be conducted utilizing wearable sensors, environmental monitors, and other novel technologies.ROLE RESPONSIBILITIES
Contribute toformulation of clinical development plans.Contributes todesign of protocols, amendments, and conduct data review, analysis and interpretation.
Develop expertise working with Pfizer clinical checklists and Standard Operating Procedures (SOPs) to ensure compliance with good clinical practice, regulatory agencies, Institutional Review Boards (IRBs), and Pfizer processes.
Develop expertise working with local SOPs pertinent to the specific site conduct of the PfIRe Lab.
Accountable for safety across the study, including regular review of safety data (including but not limited to SAEs) and response to safety issues
Ensures development of and adherence to Safety Review Plan (SRP). Consistent with Safety Review Plan, performs and documents regular review of individual subject safety data and performs review of cumulative safety data review 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 SRM01. 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 II/III.
In collaboration 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.
Participates in the development and delivery of protocol training for investigator site(s), Pfizer personnel, and CRO staff.
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 review and reports
May transition early development clinical programs into late stage development
BASIC QUALIFICATIONS"Candidate demonstrates a breadth of diverse leadership experiences and capabilities inclcuding: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact."
Requires MD
This job role does require individual to be medically qualified as defined: 1) obtained a Medical Degree from a recognized medical school, and 2) been licensed by a health authority to prescribe medicines (independent of supervision) for at least one year (post 'intern/houseman' year) and utilized that license to prescribe medicines in a patient care setting for an aggregate duration for at least one year, and 3) have always been in good standing with their licensing Health Authority.
Familiarity with related disciplines (e.g. biostatistics, regulatory, pre-clinical pharmacology, pharmaceutical sciences)
Demonstrated scientific writing skills and good communication skills
Working knowledge of GCP and ICH guidelines.
Excellent written and verbal communication and interpersonal skills.
Experience in clinical research in the academic, clinical practice or industry setting is a plus
Good working knowledge of application of digital and device technologies as well as information platforms is a plus
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