at Merck in Springfield, Illinois, United States
Job Description
Job Description
The Quantitative Pharmacology and Pharmacometrics (QP2) department 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. The team is externally visible and continues to be at the leading edge of building innovative state of the art tools. With MIDD as an essential component of decision-making at our company, this position offers an opportunity for the Director to drive pipeline impact and mentor/coach a talented group of pharmacometricians.
The Director, Pharmacometrics will work with scientists within QP2 by proactively evaluating and incorporating one or more of the following pharmacometrics capabilities into programs and thereby strengthening our pharmacometrics capabilities on a continuous basis in decision making and driving pipeline impact: population pharmacokinetics (PK) and pharmacodynamics (PD) analysis, model-based meta-analysis (MBMA), clinical trial simulations (CTS), disease progression modeling and Artificial Intelligence /Machine Learning. In addition, the individual will be accountable for coaching/mentoring talented pharmacometricians with diverse backgrounds to drive portfolio impact. Please note, this position is open to remote work. To comply with applicable law, candidates based in Sweden and Switzerland are required to work on a hybrid schedule, spending 2-3 days in the office and cannot work fully remotely.
Directors (Pharmacometrics) are expected to provide expertise in one or more of the pharmacometrics capabilities through the following responsibilities.
· Responsible for achieving results on major program deliverables by identifying, driving the development and implementation of one or more novel quantitative approaches that seek to improve cycle time, cost/size, number of trials, clinical trial design and Go/No Go decisions
· Serve as a subject matter expert and foster collaboration within QP2 and across functions to plan and execute novel analyses for informed decision making on programs
· Mentor and/or supervise junior colleagues to perform the above duties and to develop the above capabilities
· Leverage significant pharmacometrics 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.
· Maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics, authoring regulatory documents (INDs, CSRs, CTDs)
Required Experience and skills:
· (A Ph.D. or equivalent degree with at least 7 years of experience) OR (a PharmD or equivalent degree with at least 9 years of experience) OR (an MS or equivalent degree with at least 11 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 pharmaceutical sciences, pharmacometrics, mathematics, statistics/biostatistics, computational biology/chemistry, chemical/biomedical engineering, or a related field
· Extensive experience in performing population PK and PK/PD analyses using standard pharmacometrics software (e.g., NONMEM, R, Monolix, etc.)
· Deep expertise in pharmacometrics with ability to understand how (MIDD can drive portfolio and regulatory decisions
· Deep knowledge of drug development, pharmacokinetics and pharmacology and basic science skills required.
Preferred Experience and skills:
· Expertise in advanced PK/PD modeling and Pharmacometrics
· Proficiency in written and verbal communication, interdisciplinary collaboration, and problem scoping and planning
· Strong interpersonal skills that ensure teamwork and productive interactions among diverse personalities/areas of expertise
· Excellent communication Skills including 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.
· Demonstrated external visibility in the field of pharmacometrics, through publications, presentations, and involvement in professional organizations.
· Experience in developing quantitative strategies impacting pipeline decisions.
· Ability to participate in and to steer an interdisciplinary team, and to oversee the work of other scientists.
NOTICE FOR INTERNAL APPLICANTS
In accordance with Managers’ Policy – Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.
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