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ED, Pharmacometrics - Team Leader

Description

Under the direction of the Head of Clinical Pharmacology (TA- Inflammation), the incumbent would:

  • Provide visionary leadership for the BIPI Pharmacometrics Lead (PMxL) team - TA Inflammation that aligns as well advanced the overall goals for the Clinical Pharmacology Inflammation Group to ensure the development and implementation of state of the art pharmacometric strategies including performance and reporting of pharmacometric analyses (ensure Model-Informed Drug Discovery and Development (MID3)) is leveraged in drug development programs.
  • Lead and advise any pharmacometric Lead in the team who gets assigned to the role of Clinical Pharmacology and Non-Clinical Safety Science Lead (CPS) lead to ensure a successful and comprehensive CPS strategy working closely with the CPhL, DMPK, Safety Science Leads, CP head of inflammation and CPS head of inflammation.
  • Provide expert pharmacometric advice and review documents relevant to clinical development plans, submissions, and regulatory interactions. Ultimately accountable for pharmacometric guidance that is defendable to the clinical pharmacology / pharmacometrics community and regulators.
  • Coach, mentor, and raise the BIPI PMx Inflammation organization's ability to deliver and exceed expectations while creating and maintaining an open, integrative atmosphere and attractive working environment as well as opportunities for individual development.
  • The incumbent advises and assists the Head of Clinical Pharmacology (TA-Inflammation) on matters of strategy, policy, procedure, standards and interdisciplinary processes.

 

As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.

Duties & Responsibilities

  • Provides strategic leadership and direction
  • Develop and implement TA Inflammation PMx goals and strategies
  • Ensure testing, implementing and maintaining of new PMx technologies and approaches to drive clinical development programs to major milestones (e.g., POC)
  • Set directions and standards, supervise processes and procedures and implement changes and improvement where necessary
  • Ensure timely and flawless execution of high quality pharmacometrics work packages for internal decision making and registration (e.g. reports, analyses, submission documents, regulatory meetings)
  • Create a performance-based group culture with clear accountability and a sense of urgency for achieving results. Lead (recruit, hire, coach, develop, motivate, manage and monitor performance) managers and/or professionals in Clinical Pharmacology/PMx specific knowledge, processes and procedures. Set job expectations, provide regular feedback, conduct timely performance reviews, identify performance challenges, create action plans and monitor the effectiveness of those action plans. Complete Career Planning and competency assessment to ensure professional development of department members
  • Manage personnel within the group to achieve goals within Clinical Pharmacology/PMx (TA-Inflammation) in alignment with BI’s internal Talent Management policy/rules; be recognized within the organization as key scientific and personal mentor, teacher and recruiter of top scientific talent
  • Advise, assist or co-lead on matters of PMx strategy, policy, procedure, standards and interdisciplinary processes
  • Contribute to the development, optimization, and maintenance of a GCP compliant pharmacometric work environment at the US site
  • Responsible for local resource management and administration
  • Establish and maintain collaboration with leading academic experts and strategic partner CROs in the field of PMx.

Requirements

  • PhD in Medicine, Pharmacy, Mathematics, Biology or equivalent area of focus with a minimum of 8 years’ proven track record in pharmacometrics and eight to ten (8-10) years in the pharmaceutical industry preferred OR MS degree in Medicine, Pharmacy, Mathematics, Biology or equivalent area of focus, and a minimum of ten to twelve (10-12) years proven strong track record in pharmacometrics in the pharmaceutical industry may be considered.
  • People management and group development skills
  • Excellent capabilities to lead and develop employees
  • In depths scientific and strategic knowledge in the field of pharmacometrics/MID3 and knowledge of overall clinical and nonclinical drug development process
  • Ability to articulate a vision and strategy in a way that inspires and motivates a team and focuses their energy on achieving business goals
  • Process and performance oriented, constant drive to develop and implement innovative
  • approaches and processes
  • Ability to communicate effectively with internal and external opinion leaders including pharmaceutical regulatory agencies, e.g. FDA, EMA
  • Ability to challenge processes and procedures, propose changes and perform contributions to problem solving

 

Compensation:

 This position, Executive Director, Pharmacometrics - Team Leader, offers a base salary typically between $250,000.00 and $394,000.00.  The position may be eligible for a role specific variable or performance based bonus and or other compensation elements. For an overview of our benefits please click here. 

 

Desired Skills, Experience and Abilities

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