Sr Director , Data Science

We are seeking an accomplished scientific leader to join the Quantitative Pharmacology and Pharmacometrics – Oncology (QP2 Oncology) team as Senior Director, Quantitative Systems Pharmacology (QSP). QP2 Oncology is part of the Global Clinical Development organization and oversees drug development aspects related to clinical pharmacology, mechanistic PK-PD modeling, and pharmacometrics of oncology drugs from post-preclinical candidate (PCC) selection through registration.

Responsibilities

• Lead and shape the QSP strategy across the oncology portfolio, ensuring alignment with program goals and organizational priorities.
• Lead, mentor, and develop a team of quantitative scientists in a matrixed role.
• Collaborate closely with the QP2 Oncology team, preclinical DMPK and modeling teams, biologists, clinicians, and other line functions to utilize mechanistic/QSP modeling for dose selection, combination strategies, and clinical trial design.
• Ensure high-quality, regulatory-grade QSP deliverables for internal decisions, submissions, and scientific advice meetings.
• Contribute to regulatory strategy through preparation of QSP reports, briefing documents, and presentations.
• Foster a culture of scientific rigor, excellence, collaboration, and innovation, and develop best practices for QSP modeling.
• Partner with senior leaders in Translational Modeling, Discovery, and Clinical Development to define modeling strategies that influence program design and key decisions.
• Represent the company at scientific conferences, external collaborations, consortia, and industry working groups.
• Stay at the forefront of emerging methodologies in QSP and promote innovation.
• Manage activities related to budget planning, QSP vendor identification, outsourcing of QSP analyses, and contract requisitions.

Requirements

• Ph.D. with at least ten years of pharmaceutical drug development experience in systems pharmacology, systems biology, PKPD, mathematics, chemical/biomedical engineering, or a related field.
• Alternatively, a Masters or PharmD with at least fifteen years of relevant experience, demonstrating a record of increasing responsibility and independence in pharmaceutical drug development.
• Extensive and in-depth experience in developing mechanistic PK-PD models and QSP models for decision-making in early and late-stage clinical development.
• Demonstrated ability to lead an interdisciplinary team or taskforce and/or oversee the work of others.
• Oncology therapeutic area or disease knowledge.
• Experience with mechanistic modeling for antibody drug conjugates (ADCs) and/or T-cell engagers in conjunction with the immune axis (preferred).
• Experience with modeling and simulation packages or programming languages (e.g., MATLAB, R, SimBiology, Python).
• Experience working with external QSP vendors.
• Experience utilizing QSP modeling in IND, NDA, and other submissions to global regulatory agencies.
• An exemplary record of increasing responsibility, independence, and demonstrated impact in driving drug development decisions through mechanistic model-based approaches.
• Proficiency in written and verbal communication, interdisciplinary collaboration, and problem scoping and planning.

Skills

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

Pay

The salary range for this role is $210,400.00 - $331,100.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to, relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

Benefits

We offer a comprehensive package of benefits, including:

• 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.

More information about benefits is available at Merck Compensation and Benefits.

Schedule

• This position is hybrid if commutable to primary sites noted in the posting; otherwise, it is remote.
• Travel requirements: 10%.
• Flexible work arrangements available.

This role is open to US and Puerto Rico residents only.