Director of Quantitative Pharmacology and Pharmacometrics

2 days ago

MA United States Merck Full time
Job Description

Merck is seeking a highly skilled Director of Quantitative Pharmacology and Pharmacometrics to join our Research Laboratories. As a key member of our team, you will play a critical role in driving the discovery and development of novel therapeutic agents for ophthalmologic disorders.

Key Responsibilities:

  • Develop and implement model-based strategies for quantitative analyses to inform and optimize drug discovery and development.
  • Represent the Quantitative Pharmacology and Pharmacometrics department on cross-functional teams to drive streamlined development of programs within our growing ophthalmology portfolio.
  • Collaborate with other functional areas and external vendors to create an aligned, quantitative and model-informed regulatory framework to impact strategies and decisions of drug discovery and development teams.
  • Maintain a comprehensive understanding of global regulatory expectations and shape, present and defend regulatory documents and submissions.
  • Work closely with pharmacometrics team members to provide input related to analysis and reporting of modeling activities.
  • Mentor or supervise early career scientists to grow their skill sets to perform project-related duties.

Requirements:

  • 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, or an MS or equivalent degree with at least 11 years of experience.
  • Educational background in biopharmaceutics, pharmaceutical sciences, pharmacometrics, chemical/biomedical engineering, or a related field.
  • 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.
  • Direct experience in regulatory interactions.
  • 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.
  • Knowledge in modeling of complex therapeutics.
  • Flexibility to react rapidly to changing situations/environment.
  • Knowledge in ophthalmology and/or cardiometabolic clinical drug development programs.
  • Knowledge in modeling of complex ophthalmology therapeutics.

Preferred Qualifications:

  • 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 pharmacometrics 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.
  • Experience with modeling programming language(s) (e.g. R, NONMEM, R, Phoenix, or other similar packages).

About Merck:

At Merck, we're inventing for life. We're a global healthcare leader working to help the world meet new breakthroughs that affect generations to come. We're committed to fostering an inclusive and diverse workplace, where talented individuals can engage in a hiring process that exhibits their true capabilities. We're 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.

Equal Employment Opportunity:

Merck is 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.

Pay Transparency Nondiscrimination:

Merck is committed to pay transparency nondiscrimination. We're proud to be a company that values fairness and equity in all aspects of our business, including compensation and benefits.

Relocation:

Merck offers relocation assistance to support our employees' career growth and development. We're committed to helping our employees and their families navigate the relocation process, ensuring a smooth transition to their new role.

Flexible Work Arrangements:

Merck offers flexible work arrangements to support our employees' work-life balance. We're committed to providing a supportive and inclusive work environment that allows our employees to thrive and grow in their careers.

Valid Driving License:

Merck does not require a valid driving license for this position.

Hazardous Material(s):

N/A

Required Skills:

Business Intelligence (BI), Database Design, Data Engineering, Data Modeling, Data Science, Data Visualization, Machine Learning, Software Development, Stakeholder Relationship Management, Waterfall Project Management

Preferred Skills:

Job Posting End Date: 10/31/2024

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.

Requisition ID: R315438

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