The Quantitative Pharmacology and Pharmacometrics (QP2) department within Pharmacokinetics, Pharmacodynamics, and Drug Metabolism (PPDM) drives model-informed drug discovery and development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions.
The Pharmacometrics group within QP2 brings an experienced leadership team, deep modeling expertise and state-of-the-art modeling approaches across multiple therapeutic areas and modalities to drive portfolio impact from discovery through life-cycle management.
Our team is externally visible and continues to be at the leading edge of building innovative tools. With MIDD as an important component of decision-making at our Company, this position offers an opportunity to drive pipeline impact and lead a talented group of pharmacometricians!
This position will work within QP2 to strengthen our pharmacometric capabilities on a continuous basis by evaluating and incorporating Modeling and Simulation (M&S) tools in decision making and drive pipeline impact. In addition, the Director will be accountable for directing a team of talented pharmacometricians with diverse backgrounds, coaching/mentoring of staff and bringing subject matter expertise related to model informed drug discovery and development for programs at our Rahway, New Jersey or West Point, Pennsylvania locations.
We seek a Director in Pharmacometrics to provide strategic direction for pharmacometrics through the following responsibilities:
Guide a team of approximately 10 pharmacometricians including people management, scientific and operational oversight
Leverage significant pharmacometric and subject matter expertise in a broad range of therapeutic areas, modalities and stages of drug discovery/development to independently provide day-to-day coaching/guidance to individual contributors
Responsible for achieving results via others on major program drivers by implementing novel quantitative approaches that seek to improve cycle time, cost/size and number of trials, implementation of tools and regulatory framework for rapid approvals and driving Go/No Go decisions on programs
Responsible for priority-setting, performance management, hiring and retention, and talent development/management for direct reports
Accountable for managing and allocating pharmacometric resources for project teams and overseeing an outsourcing budget
Working with senior management, substantially contributes to the development and execution of departmental priorities and ensures broad alignment of individual priorities/performance of team with QP2 vision/mission
Manages and initiates external collaborations with world leading experts to develop new methodologies
Fosters collaboration within QP2 to achieve results, remove barriers on portfolio or scientific priorities
May provide functional representation on committees, task forces or initiatives spanning beyond QP2
Provides review and scientific input on reports and regulatory documents at all stages of development
Maintains appropriate quality systems and IT infrastructure for QP2
Required Education: Ph.D. in Pharmaceutical Sciences / Pharmacometrics or related quantitative fields or equivalent degree with ≥ 10 years of experience OR a PharmD or equivalent degree with ≥ 12 years of experience OR an MS or equivalent degree with ≥ 15 years of experience
At least 10 years of discovery/drug development/regulatory experience
Deep expertise in pharmacometrics (e.g., population PK and PK/PD analyses, model-based meta-analysis, dose-response and exposure-response analyses, disease modeling, trial simulation, optimal study designs, strategic decision analyses, economic modeling) with ability to understand how Model-Informed Drug Development (MIDD) can drive portfolio and regulatory decisions
Experience in managing a group of Pharmacometricians
Deep knowledge of drug development, pharmacokinetics and pharmacology and basic science skills required
Expertise in advanced PK/PD modeling and Pharmacometrics
Proficiency in written and verbal communication, interdisciplinary collaboration, and problem scoping and planning.
Good interpersonal skills that ensure teamwork and productive interactions among diverse personalities/areas of expertise
Communication Skills: demonstrates ability to effectively present complex data, development plans and strategies to various audiences in both verbal and written form, steer and influence interpretations (including impact) and conclusions for reports and regulatory documents that are clear and concise
Emerging leader in the field of Pharmacometrics with a track record of sustained external visibility, through publications, presentations and/or involvement in professional organizations
Demonstrated ability to apply appropriate FDA, European Medicines Agency (EMA) and other/ International Council for Harmonization Good Clinical Practice (ICH) guidelines in the application of predictive model-based approaches in the design of development plans and study design
Extensive experience in developing quantitative strategies for impacting pipeline decisions
Demonstrated ability to participate in and to steer an interdisciplinary team, and to oversee the work of other scientists
We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.
Who we are …
We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
What we look for …
In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.
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Employee Status: Regular
VISA Sponsorship: Yes
Number of Openings: 1
Requisition ID: R120369
Internal Number: R120369
About Merck & Co., Inc.
About our CompanyWe aspire to be the premier research-intensive biopharmaceutical company in the world. Innovation and scientific excellence are at the core of what we do in pursuit of our mission to save and improve lives. Together, we invent for a more hopeful future. Who we areOur company, Merck (known as MSD outside of the U.S. and Canada), is a global health care leader with a diversified portfolio of prescription medicines, vaccines, and animal health products. For more than 125 years we have been inventing for life. Today, we continue to be at the forefront of research to prevent and treat diseases that threaten people and animals – including cancer, infectious diseases like HIV and Ebola, and emerging animal diseases. We hire the most brilliant minds because inventing for life depends on our work. Our dedicated employees come from an array of backgrounds and do many different things—from research and development and business technology to marketing and pharmaceutical sales. Yet each of us knows our work matters. At Merck, you'll find rewarding opportunities, diverse experiences, and an unwavering commitment to ethics and integrity. You'll collaborate with talented colle...agues who share your sense of purpose. Our company will empower you to innovate, explore, and develop your full potential in our possibility-rich environment. Join our team and help us invent, impact, and inspire every day.