Director Infectious Diseases and Vaccines, Quantitative Pharmacology and Pharmacometrics (Hybrid)
USA - Pennsylvania - West Point
Full Time Executive-level / Director USD 181K - 285K
MSD
At MSD, we're following the science to tackle some of the world's greatest health threats. Get a glimpse of how we work to improve lives.Job Description
Directors in Quantitative Pharmacology and Pharmacometrics (QP2) 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. Directors perform job duties independently with minimal supervision, lead QP2 efforts on drug development programs, and author strategic documents.
Directors are expected to have or be developing expertise in several areas, including:
Serving as an expert representative for QP2 on Infectious Disease/Vaccine development teams
Framing critical drug development questions for optimizing model-based development
Developing and executing translational PK/PD models, population pharmacokinetic models, exposure-response and, stratification biomarker models, quantitative system pharmacology (QSP) and disease progression models, clinical trial design via outcome/enrollment modeling and simulation, comparator modeling, absorption/biopharmaceutical modeling, clinical utility index modeling, and other model-based analyses
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
In partnership with key cross-functional area experts, strategically frame and progress issues related to clinical pharmacology and biopharmaceutics
Mentoring and/or supervising junior colleagues to perform the above duties and to develop the above capabilities
The Director is a skilled quantitative drug/vaccine developer, with a strong, integrated understanding of the strategic elements of drug discovery and development. They develop strategies for quantitative analyses (and commensurate experiments/trials) within and across development programs and/or functions. In addition to the responsibilities described above, Directors demonstrate outstanding leadership and communication skills. They collaborate with other functional areas, as well as with external vendors and partners, creating an aligned, quantitative and model-informed regulatory framework to impact strategies and decisions of drug development teams.
This role will be focused on efforts in the infectious disease and vaccines therapeutic area.
Required:
a Ph.D. or equivalent degree with at least seven years of experience OR (a PharmD or equivalent degree with at least nine 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.
Experience with modeling programing language(s) (e.g. R, NONMEM, Matlab, SAS, or other similar )
Direct experience in regulatory interactions and filings for small molecule and/or biologic drug development
Preferred:
Prior experience working in Infectious Disease and/or Vaccines
An exemplary record of increasing responsibility, independence, and demonstrated impact in driving drug development decisions through application of model-based approaches in the pharmaceutical industry.
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, Monolix, Phoenix, etc.)
Expert skills in experimental design, mathematical problem solving, critical data analysis/interpretation, and statistics.
Scientific understanding of biopharmaceutical and ADME properties of small molecules and/or 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
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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U.S. Hybrid Work Model
Effective 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, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here.
Search Firm Representatives Please Read Carefully
Merck & 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:
Domestic/InternationalVISA Sponsorship:
YesTravel Requirements:
10%Flexible Work Arrangements:
HybridShift:
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:
07/24/2024*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.
Tags: Biology Biostatistics Business Intelligence Chemistry Data analysis Data visualization Drug discovery Engineering Machine Learning Mathematics Matlab Pharma R Research SAS Statistics
Perks/benefits: Career development Flex hours Flex vacation Health care Insurance Relocation support Salary bonus Transparency
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