Director, Quantitative Pharmacology and Pharmacometrics, Immune/Oncology (Remote)

Merck Director, Quantitative Pharmacology and Pharmacometrics – Immune / Oncology - Remote Honolulu, Hawaii

We are seeking an experienced talented scientist to join the Quantitative Pharmacology and Pharmacometrics – Immune / Oncology (QP2-IO) team in the role of Director. The QP2-IO team is part of the Global Clinical Development organization and has oversight over drug development aspects related to clinical pharmacology and pharmacometrics of oncology drugs from post-PCC to registration. Directors are leaders in the field of quantitative drug development, with a strong, integrated understanding of the strategic elements of drug development. As a subject matter expert, the Director within the QP2-IO Group will work closely with teams of highly collaborative, cross-functional scientists to contribute to the development of novel chemical entities. They develop strategies for quantitative analyses (and commensurate experiments / trials) within and across development programs and / or functions. Directors demonstrate outstanding leadership and communication skills. They collaborate within QP2-IO and with other functional areas, as well as with external vendors and partners, creating an aligned, quantitative framework to impact strategies and decisions of drug development teams.

Primary Responsibilities :

• Serving as an expert representative for QP2-IO on Oncology development teams.
• Framing critical questions and strategy for optimizing model-based analyses on programs.
• Developing and executing model-based analyses including translational PK / PD approaches, population pharmacokinetic models, exposure-response models, clinical trial design simulation, disease progression models, quantitative systems pharmacology (QSP) modeling, and comparator modeling.
• Strategizing and executing modeling of tumor size and survival.
• Maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics in Oncology, authoring regulatory documents (investigational new drugs / INDs, clinical study reports (CSRs), clinical trial applications (CTDs), and representing QP2-IO at regulatory meetings.
• Mentoring and / or supervising junior staff to perform the above duties and to develop the above capabilities.

Minimum Qualifications :

Required Experience :

This (remote) position is only applicable for those that are not within commutable distance to primary sites noted in posting. If commutable, please see requisition “#R322797”.

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 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.

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, Monday - 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.

The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Expected US salary range : $200,200.00 - $315,100.00

Available 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.

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Salary : $200,200 - $315,100