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About the Role

This role provides strategic leadership and scientific oversight to a portion of the cardiometabolic (CMD) therapeutic area portfolio within the Quantitative Pharmacology and Pharmacometrics (QP2) department. The Team Leader (Senior Director) will apply cutting-edge quantitative pharmacology and pharmacometrics strategies to advance the internal portfolio, oversee a team of QP2 scientists, and serve as the QP2 lead on assigned projects. This position is part of the extended QP2 leadership team and is expected to contribute to leadership and active contributions to business or talent-facing workstreams. Senior Directors are recognized as scientific thought leaders who develop and implement translational PK/PD strategies, characterize clinical pharmacokinetics and pharmacodynamics, and shape regulatory strategy, dose selection, and go/no-go decisions.

Responsibilities

Leading a team of up to 4 QP2 scientists, including people management, scientific and operational oversight, under the direction of the Executive Director of QP2- CMD.
Leveraging end-to-end drug discovery/development and disease area expertise to independently provide day-to-day scientific oversight to individual contributors.
Setting priorities for direct reports and driving performance management, hiring and retention, staff development and training, and input into calibration and talent management processes.
Serving as an expert representative for QP2 on discovery and drug development teams and engaging in cross-functional and governance discussions, including business development and licensing evaluations.
Maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics, contributing to cross-functional regulatory strategy, and authoring regulatory documents (INDs, CSRs, CTDs).
Developing and applying mechanistic, disease progression, and comparator modeling platforms to help drive portfolio decisions.
In partnership with the Executive Director of CMD, identifying resource needs and contributing to resource allocation internally.
Serving as QP2 lead on assigned projects.

Requirements

Ph.D./PharmD or equivalent degree with at least 10 years of experience with increasing responsibility and independence in pharmaceutical drug development or regulatory.
Educational background in biopharmaceutics, pharmaceutical sciences, pharmacometrics, chemical/biomedical engineering, mathematics, statistics/biostatistics, computational biology/chemistry, or a related field.
Extensive experience in developing quantitative strategies for impacting pipeline decisions and drug development expertise.
Demonstrated ability to lead an interdisciplinary team or taskforce, and/or to oversee the work of others.
Record of ability to operate in an inclusive and high-performance work environment applying enterprise ways of working principles including fostering collaboration and driving results, while managing ambiguity.
Relevant regulatory and quantitative pharmacology experience.
Proficiency in written and verbal communication, interdisciplinary collaboration, and problem scoping and planning.

Skills

Clinical Development
Clinical Pharmacology
Data Modeling
Data Science
Data Visualization
Dose Response Analysis
Drug Development
Pharmaceutical Sciences
Pharmacometrics
Product Approvals
Regulatory Strategies
Stakeholder Relationship Management
Strategic Leadership
Team Management
Cardiometabolic

Location

Remote
Hybrid

Work Type

Hybrid
Remote
Regular

Experience Level

Senior Director
10 years of experience

Education Level

Ph.D.
PharmD

Salary/Compensations

$210,400.00 - $331,100.00

Benefits

Annual bonus
Long-term incentive
Medical, dental, vision healthcare and other insurance benefits (for employee and family)
Retirement benefits, including 401(k)
Paid holidays, vacation, and compassionate and sick days

About the Company

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities.
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.

Equal Opportunity

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: EEOC Know Your Rights
EEOC GINA Supplement
Learn more about your rights, including under California, Colorado and other US State Acts
San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance