Global Head, Pharmacometrics

Pfizer
La Jolla, California; New York City, New York; Collegeville, Pennsylvania; Cambridge, Massachusetts
Competitive
December 02 2020
4799902
Full Time
Pharma
ROLE SUMMARY

The Global Head of Pharmacometrics is responsible to lead and manage the Global Pharmacometrics Group, and to ensure delivery of pharmacometric contributions and deliverables to all Clinical Development Plans and global project teams across the Pfizer R and D enterprise. They lead approximately 35 PhD-level pharmacometricians, located in various global locations, deriving from multiple scientific backgrounds and disciplines delivering a diverse range of contributions (PK/PD analyses, model based meta-analysis, disease area evidence synthesis and models, NCA pharmacokinetic (PK) Analyses, etc.) for the Pfizer enterprise and to deliver significant time and resource savings towards Bold Move 2.3. They are responsible for the development and maintenance of tools utilized by the Global CP organization, and for development of pharmacometric-related training programs/materials to be used across Research and Development.

ROLE RESPONSIBILITIES

Global Head, Pharmacometrics :
  • Leads the global pharmacometrics function; sets the vision for the team to deliver contributions to Clinical Development Plans encompassing all therapeutic areas.
  • Directly manages pharmacometrics resources in a diverse global organization.
  • In collaboration with GPD/Worldwide Research & Development (WRD), Development China and Development Japan Clinical Pharmacology Heads, ensures that pharmacometric resources are strategically allocated to support projects and disease areas.
  • Partners with GPD/WRD Clinical Pharmacology Headsand other line leaders in Statistics Heads, Regulatory, CSOs and CDOs and others to identify opportunities for pharmacometric to improve the speed and quality of drug discovery and development.
  • Ensures "cutting edge" pharmacometric tools, methods and training are available to serve disease area and indication needs in drug development.
  • Develops state-of-the-art pharmacometric tools, methods, and training and continuously improves our best practices through collaborations and interactions with internal and external experts.
  • Drug Development [EQDD], Enhanced Clinical Trial Design [ECTD], etc).
  • Member of the Global Clinical Pharmacology Leadership Team.
  • Ensures standardization of non-compartmental pharmacokinetic analyses for all clinical pharmacology studies across the Pfizer development organizations.
  • Develops efficient and standardized approaches to report results of non-compartmental analyses and more complex modeling and simulation work.
  • Hire, coach, mentor and develop pharmacometricians arising from a range of disciplines (clinical pharmacology, statistics, pharmacokinetics, engineering, medicine) in the Pharmacometrics group.
  • Influence and leads in the external environment through scientific publication and presentation and through support of academic, industrial and regulatory collaborations to build and ensure Pfizer's global reputation and standing in the clinical development modeling and simulation communities.


BASIC QUALIFICATIONS
  • Doctoral degree (Ph.D/Pharm.D) with extensive post-graduate training/experience in pharmacokinetics, pharmacodynamics, pharmacometrics or equivalent qualifications.
  • A minimum of 15 years of experience with a proven record of leadership and ability to recruit top scientists.
  • Very thorough understanding of pre-clinical and clinical drug development strategies and processes from Phase I - III.
  • Extensive direct experience in the use of pharmacometric methods to support regulatory submissions and interactions with regulatory agencies.
  • Very good understanding of the (actual and potential) application of pharmacometric methods in the commercial domains.
  • Experience in managing multiple, complex projects and working across different lines.
  • Proven track record of clinical submission and regulatory query resolution is essential.
  • Knowledge of worldwide regulatory expectations related to pharmacometrics is required.
  • Proven record of managerial/supervisory and leadership excellence, talent identification and development, effective team building, conflict management, strategic agility and business acumen.
  • Able to effectively lead matrix teams and manage a diverse and dynamic workload.
  • Proven ability to develop effective partnerships in a global, matrix environment.
  • Experience overseeing contract research organizations.
  • Highly effective verbal and written communication skills.
  • Enterprise leadership of culture and behaviors.


NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
  • Required to travel to sites or meetings (up to 40% of time).
  • Weekend and evening travel is required on occasions.


Other Job Details:
  • Eligible for Employee Referral Bonus: YES


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