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Director – Pharmacometrics, Quantitative Pharmacology and Pharmacometrics Fulltime
Join our exhilarating team as Director of Pharmacometrics and drive innovative drug development strategies, impacting global health positively. Lead a talented group of pharmacometricians to revolutionize model-informed drug discovery. Shape the future with us through pioneering MIDD approaches. Apply now for this transformative opportunity.
Summarize by CVGorilla
Job DescriptionThe 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 APPLICANTSIn 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.Current Employees apply HERECurrent Contingent Workers apply HEREUS and Puerto Rico Residents Only:Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:EEOC Know Your RightsEEOC GINA SupplementPay Transparency NondiscriminationWe are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.Learn more about your rights, including under California, Colorado and other US State ActsU.S. Hybrid Work ModelEffective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.Expected salary range:$181,600.00 – $285,800.00Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here.Search Firm Representatives Please Read CarefullyMerck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.Employee Status:RegularRelocation:DomesticVISA Sponsorship:YesTravel Requirements:10%Flexible Work Arrangements:RemoteShift:1st – DayValid Driving License:NoHazardous Material(s):N/ARequired Skills:Business Intelligence (BI), Database Design, Data Engineering, Data Modeling, Data Science, Data Visualization, Machine Learning, Project Management, Software Development, Stakeholder Relationship ManagementPreferred Skills:Job Posting End Date:07/12/2024• A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.Job Posting End Date:07/12/2024A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.Requisition ID:R293653
