This Senior Principal Scientist role is intended to provide leadership for the immunology therapeutic area and drive the integration of immunology-driven targets across the broader suite of therapeutic areas. Senior Principal Scientists in Quantitative Pharmacology and Pharmacometrics (QP2) oversee and directly apply quantitative approaches to characterize clinical pharmacokinetics and pharmacodynamics of new chemical entities and biologics, inform dose selection and go/no-go decisions, and shape, present and defend regulatory strategies to support global regulatory submissions and post-approval expansions in indications.
Senior Principal Scientists provide strategic leadership and oversight, both supervising the work of other scientists and a portfolio of projects and leading QP2 efforts on drug development programs. Senior Principal Scientists are expected to have or be developing expertise in several areas, including:
Overseeing a portfolio of programs (including both program strategy and execution) across the immunology portfolio
Driving the development of mechanistic, disease progression and comparator modeling platforms to help drive portfolio decisions
Serving as an expert representative for QP2 on drug development teams and in cross-functional and governance discussions regarding the immunology portfolio, including business development and licensing evaluations
Framing critical drug development questions for optimizing model-based development via translational PK/PD, population pharmacokinetic, exposure-response, quantitative system pharmacology (QSP) and disease progression models
Influencing clinical trial design via trial simulations and comparator modeling
Maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics, authoring regulatory documents (INDs, CSRs, CTDs), and representing QP2 at regulatory meetings
Mentoring and/or supervising junior colleagues to perform the above duties and to develop the above capabilities
The Senior Principal Scientist is a skilled quantitative drug developer, with a strong, integrated understanding of the strategic elements of drug discovery and development that can represent the combined efforts of QP2 and the wider Department of Pharmacokinetics, Pharmacodynamics and Drug Metabolism (PPDM). She/he develops strategies for quantitative analyses (and commensurate experiments/trials) within and across development programs and/or functions. In addition to the responsibilities described above, Senior Principal Scientists demonstrate outstanding leadership and communication skills, collaborating across PPDM and with other functional areas, as well as with external vendors and partners to create a quantitative model-informed approach to impact program strategies and decision making on drug development teams.
(a Ph.D. or equivalent degree with at least 10 years of experience) OR (a PharmD or equivalent degree with at least 12 years of experience) OR (an MS or equivalent degree with at least 14 years of experience), where “experience” means having a record of increasing responsibility and independence in a similar role in pharmaceutical drug development or academia.
Educational background in biopharmaceutics, pharmaceutical sciences, pharmacometrics, mathematics, statistics/biostatistics, computational biology/chemistry, chemical/biomedical engineering, or a related field.
Drug development expertise within the immunology therapeutic area, including a record of both internal and external impact in driving model-informed drug development strategies within immunology programs
Ability to influence regulatory strategies including independently formulating registration packages to support global filings, a strong understanding of clinical pharmacology studies to support intrinsic/extrinsic factors, ability to independently author, defend regulatory filings.
Experience in performing population PK/PKPD analyses using standard pharmacometric software (e.g. NONMEM, R, Monolix, Phoenix, etc.)
Scientific understanding of biopharmaceutical and ADME properties of both small molecules and biologics
Proficiency in written and verbal communication, interdisciplinary collaboration, and problem scoping and planning.
Demonstrated ability to participate in and to lead 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: R119650
Internal Number: R119650
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.