The Head of the Pfizer Clinical Research Units (PCRUs) is a senior and highly experienced physician that will lead the PCRU organization and will also serve as Medical Director at the New Haven (NH) PCRU or Brussels PCRU.
As Head of the PCRU organization, this role:
Sets strategic direction and provides global leadership to the PCRU Organization
Leads and manages Pfizer’s global internal clinical research units (facilities, systems, people, policies) and the clinical operations of early phase trials therein
Assures operational excellence and quality of PCRU systems, operations, and deliverables across the PCRU enterprise
Supports Pfizer’s precision medicine and global drug development capabilities
Serves as the single point of accountability for the placement and execution of clinical development studies at the PCRUs
As Medical Director in one of the PCRUs, acts as the PCRU Site Head and has overall accountability for all site-based operational and clinical affairs:
Provides leadership of all operations within the PCRU (general, clinical, medical, laboratory)
Leads the medical function and medical staff within the PCRU; may also serve as an Investigator on studies conducted in the PCRU
Has overall accountability for medical safety decisions associated with studies conducted in the research unit and for the safety of subjects participating in PCRU studies
the application of global standards within the PCRU and is directly accountable for the quality of all operational deliverables
novel and innovative approaches to trial design and study conduct
for cultivating relationships with local key medical and health care providers and institutions, as appropriate to the business
Key Responsibilities as PCRU Global Head:
Aligns the clinical operations and capabilities of the PCRUs to enable rapid, efficient and high quality early phase clinical trial execution
Sets strategic direction and provides input, guidance, and oversight to trial execution
Ensures best practices, human research subject protection, knowledge sharing and optimal capacity utilization, global standardization and continuous improvement
Establishes policies and procedures on clinical and operational practices and assures exemplary medical and ethical standards to assure volunteer safety and quality
Develops and maintains capabilities within the PCRUs (staff, facilities, equipment) to conduct a broad range of exploratory development/precision medicine studies
Enables strategy for global placement of early development clinical pharmacology studies to assure appropriate PCRU utilization
Devises, coordinates and assures implementation of emerging technologies to enhance the PCRUs efficiency, productivity, and competitiveness
Interacts globally with Pfizer colleagues and RUs and with academic institutions, investigators and external healthcare entities to support R&D objectives
Develops talent to meet the needs of the business
Establishes performance, quality, customer service, business efficiency and innovation metrics for PCRUs
Key Responsibilities as New Haven or Brussels PCRU Medical Director::
Provides leadership to, and general management of, the PCRU’s daily operations; assures the integrity of decision making and operational functioning of the PCRU
Ensures appropriate operational-scientific conduct of clinical research studies in healthy volunteers and/or patients
Accountable for medical safety decisions associated with studies conducted in the PCRU (e.g. safety monitoring, dose initiation, dose escalation, study continuation, etc.)
Ensures the appropriate identification/diagnosis, analysis and treatment, and attribution of clinical adverse events for studies conducted in the PCRU
Ensures the protection of study participant research rights and oversight of volunteer/patient clinical safety
Ensures compliance with Pfizer policies and SOPs, research ethics standards, ICH, and all other applicable regulatory and legal requirements
and supports a work environment of openness, individual empowerment, individual accountability, and career development
Leads, coaches, provides feedback to, trains and develops, the PCRU management team as a multidisciplinary team of people who will direct and administrate the planning, scheduling, volunteer recruitment, implementation/execution, and summarization of all studies conducted in the PCRU
Mentors colleagues both in the areas of functional expertise and management/ administration
high standards for protocol design and conduct, to ensure that studies are conducted to the highest medical & ethical standards and ensure that GCP (Good Clinical Practice) is being followed and comments on protocols for the Clinical Pharmacology Study Design Committee (an early development protocol governance committee) and participates in these governance meetings, as applicable.
in First-in-Human (FIH) consensus meetings, as applicable.
as a consultant to Study Teams, as needed
Leads, assists, or participates in training courses (of or with PCRU), as appropriate
Interacts, as necessary, with Pfizer colleagues in the US, EU, Japan, and the other PCRU, as well as with academic and practicing physicians and other external healthcare, scientific and business/commercial colleagues to implement study protocols and ensure best practices
prioritizes and coordinates efforts to enhance seamless collaboration between internal and external customers of the PCRU; ensures that the PCRU staff and site goals are consistent with global PCRU and Pfizer Clinical Development strategies
Must be eligible for, and attain, medical licensure per local state/jurisdiction requirements
A minimum of 10 years of independent relevant clinical care experience with at least 5 years direct experience in either academic or pharmaceutical clinical pharmacology/clinical research investigation
Previous direct work experience in a clinical research unit management strongly preferred
A minimum of 15 years of overall drug development experience is desired with a minimum of 7 years of experience in early/exploratory/learning phase drug development and preclinical drug development, that includes:
Thorough knowledge of clinical pharmacology, clinical research process, and international regulatory requirements for clinical research
Strong background/experience in exploratory drug development, including execution of patient/healthy volunteer trials to support decision-making
Exposure to preclinical sciences: pharmacology, toxicology, pharmacokinetics, toxico-kinetics, exposure margins, pharmacodynamics, biomarkers – especially as they relate to translation to protocol design for first-in-human studies
Thorough knowledge of Good Clinical Practice (GCP) (required)
Thorough understanding of Phase 1 through Phase 4 clinical research and development
Training in leadership, supervisory and management skills, with > 10 years proven experience in a leadership/management and/or a people management role (including: feedback and coaching, allocation of limited resources, staff development, change facilitation, etc.)
Understands the critical nature of good teamwork and can work and propagate their influence in a highly matrixed, multidisciplinary team environment
Relevant experience in developing budgets (operating & clinical research studies), forecasts, justifying costs and managing performance against budget(s)
Demonstrated scientific productivity (e.g. publications, research reports)
Strong and practical leader with proven track of delivering “customer” needs
Skilled negotiator and influencer, comfortable with implementing change
Must have excellent working knowledge of computers
Understanding of patient safety issues and medical/legal considerations
Understanding of bioethical principles and human research rights and protections
Understanding of quality assurance and continuous quality improvement
Language skills – Excellent verbal and written communication skills in English required
Responsible for an operating budget of approximately $35M to $45M annually.
Manages a global organization of approximately 150-200 clinical development colleagues and 50-75 contractors.
Manages a group of 6 to 10 direct reports, which are Director/Senior Director and/or Site Leaders.
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N (Other) (United States of America)
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