Merck
Overview
The Quantitative Pharmacology and Pharmacometrics (QP2) department drive 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 Pharmacometrics leader to drive pipeline impact and lead a talented group of pharmacometricians. This director will be part of a leadership team responsible for applying traditional and state-of-the-art pharmacometric approaches on the portfolio and continue to innovate our pharmacometrics capabilities on a continuous basis. The Director will be accountable for directing a team of pharmacometricians with diverse backgrounds and bringing subject matter expertise related to model informed drug discovery and development for programs. Responsibilities
Guide a team of approximately 5-6 pharmacometricians to achieve results on major program drivers by identifying and implementing novel quantitative approaches (for example, comparator modeling, clinical trial simulations, quantitative system pharmacology (QSP) and disease progression models, artificial intelligence algorithms, machine learning methods) that seek to improve cycle time, cost/size and number of trials, implementation of tools and regulatory framework for rapid approvals and driving Go/No Go decisions on programs
Foster collaboration within QP2 to achieve results, remove barriers on portfolio or scientific priorities
Initiate and manage external collaborations to develop new methodologies and lead our external outreach to the scientific pharmacometrics community
Evaluate and maintain appropriate quality systems and IT infrastructure for QP2 to support emerging capabilities
Responsible for priority-setting, performance management, hiring and retention, and talent development/management for direct reports
Required Experience
a Ph.D. or equivalent degree with 7+ years of experience OR a PharmD or equivalent degree with 9+ years of experience OR an MS or equivalent degree with 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 pharmacometrics, pharmaceutical sciences, mathematics, statistics/biostatistics, computational biology/chemistry, chemical/biomedical engineering, or a related field.
Deep expertise in pharmacometrics (e.g., population PK and PK/PD analyses, model-based meta-analysis, dose-response and exposure-response analyses, disease modeling, trial simulation, optimal study designs, strategic decision analyses, economic modeling, artificial intelligence algorithms, machine learning methods) 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
Extensive experience in developing quantitative strategies for impacting pipeline decisions
Drug development and regulatory experience agnostic of therapeutic area, including a record of PMx impact in driving model-informed drug development strategies across programs
Good interpersonal and communication skills that ensure teamwork and productive interactions among diverse personalities/areas of expertise
US 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 contact us if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit the following resources: EEOC Know Your Rights; EEOC GINA Supplement. We are proud to be a company that embraces the value of bringing together talented and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills 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 Acts. U.S. Hybrid Work Model: Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work schedule consisting of three total days on-site per week, Monday - Thursday, with Friday remote, unless business critical tasks require on-site presence. This model does not apply to roles that have been designated as remote or other excluded positions. Salary range for this role is $206,200.00 - $324,600.00. The actual compensation will depend on factors including education, qualifications, experience, location, and business needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive benefits package including medical, dental, vision, retirement benefits (401(k) with company match), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at the company compensation and benefits page. You can apply for this role through the company careers site (or via Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. Equal Opportunity and Local Compliance Statements by Location
San Francisco and Los Angeles residents: we will consider qualified applicants in accordance with local laws, including fair chance processes where applicable. Search Firm Representatives: Merck & Co., Inc. does not accept unsolicited assistance from search firms for employment opportunities. No fee will be paid in the event a candidate is hired as a result of an agency referral where no pre-existing agreement is in place.
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The Quantitative Pharmacology and Pharmacometrics (QP2) department drive 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 Pharmacometrics leader to drive pipeline impact and lead a talented group of pharmacometricians. This director will be part of a leadership team responsible for applying traditional and state-of-the-art pharmacometric approaches on the portfolio and continue to innovate our pharmacometrics capabilities on a continuous basis. The Director will be accountable for directing a team of pharmacometricians with diverse backgrounds and bringing subject matter expertise related to model informed drug discovery and development for programs. Responsibilities
Guide a team of approximately 5-6 pharmacometricians to achieve results on major program drivers by identifying and implementing novel quantitative approaches (for example, comparator modeling, clinical trial simulations, quantitative system pharmacology (QSP) and disease progression models, artificial intelligence algorithms, machine learning methods) that seek to improve cycle time, cost/size and number of trials, implementation of tools and regulatory framework for rapid approvals and driving Go/No Go decisions on programs
Foster collaboration within QP2 to achieve results, remove barriers on portfolio or scientific priorities
Initiate and manage external collaborations to develop new methodologies and lead our external outreach to the scientific pharmacometrics community
Evaluate and maintain appropriate quality systems and IT infrastructure for QP2 to support emerging capabilities
Responsible for priority-setting, performance management, hiring and retention, and talent development/management for direct reports
Required Experience
a Ph.D. or equivalent degree with 7+ years of experience OR a PharmD or equivalent degree with 9+ years of experience OR an MS or equivalent degree with 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 pharmacometrics, pharmaceutical sciences, mathematics, statistics/biostatistics, computational biology/chemistry, chemical/biomedical engineering, or a related field.
Deep expertise in pharmacometrics (e.g., population PK and PK/PD analyses, model-based meta-analysis, dose-response and exposure-response analyses, disease modeling, trial simulation, optimal study designs, strategic decision analyses, economic modeling, artificial intelligence algorithms, machine learning methods) 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
Extensive experience in developing quantitative strategies for impacting pipeline decisions
Drug development and regulatory experience agnostic of therapeutic area, including a record of PMx impact in driving model-informed drug development strategies across programs
Good interpersonal and communication skills that ensure teamwork and productive interactions among diverse personalities/areas of expertise
US 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 contact us if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit the following resources: EEOC Know Your Rights; EEOC GINA Supplement. We are proud to be a company that embraces the value of bringing together talented and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills 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 Acts. U.S. Hybrid Work Model: Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work schedule consisting of three total days on-site per week, Monday - Thursday, with Friday remote, unless business critical tasks require on-site presence. This model does not apply to roles that have been designated as remote or other excluded positions. Salary range for this role is $206,200.00 - $324,600.00. The actual compensation will depend on factors including education, qualifications, experience, location, and business needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive benefits package including medical, dental, vision, retirement benefits (401(k) with company match), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at the company compensation and benefits page. You can apply for this role through the company careers site (or via Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting. Equal Opportunity and Local Compliance Statements by Location
San Francisco and Los Angeles residents: we will consider qualified applicants in accordance with local laws, including fair chance processes where applicable. Search Firm Representatives: Merck & Co., Inc. does not accept unsolicited assistance from search firms for employment opportunities. No fee will be paid in the event a candidate is hired as a result of an agency referral where no pre-existing agreement is in place.
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