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Planning Oncology Leadership Innovation Compassion Mathematics Outsourcing Data Science Pharmacology Data Modeling Program Design Pharmaceuticals Clinical Trials Decision Making Database Design Systems Biology Drug Development Pharmacodynamics Pharmacokinetics Machine Learning Telephone Skills Data Engineering Influencing Skills Data Visualization Software Development Contingent Workforce Programming Languages Clinical Pharmacology Business Intelligence Waterfall Methodology Biomedical Engineering Relationship Management Pre-Clinical Development R (Programming Language) Verbal Communication Skills Python (Programming Language) Influencing Without Authority Interdisciplinary Collaboration Non-Disclosure Agreement (Intellectual Property Law), 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 has oversight over drug development aspects related to clinical pharmacology, mechanistic PK-PD modeling and pharmacometrics of oncology drugs from post-preclinical candidate (PCC) selection through registration.

Our Senior Directors are recognized experts in quantitative drug development and possess a deep, integrated understanding of both the science and the strategic, end-to-end dimensions of oncology drug development. Reporting directly to Executive Director and Section Head, QP2 Oncology, the Senior Director will provide leadership and scientific oversight to all QSP and mechanistic modeling efforts across the oncology portfolio.

Primary 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.
• Work in close collaboration with 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 and outsourcing of QSP analyses and contract requisitions., Planning Oncology Leadership Innovation Compassion Mathematics Outsourcing Data Science Pharmacology Data Modeling Program Design Pharmaceuticals Clinical Trials Decision Making Database Design Systems Biology Drug Development Pharmacodynamics Pharmacokinetics Machine Learning Telephone Skills Data Engineering Influencing Skills Data Visualization Software Development Contingent Workforce Programming Languages Clinical Pharmacology Business Intelligence Waterfall Methodology Biomedical Engineering Relationship Management Pre-Clinical Development R (Programming Language) Verbal Communication Skills Python (Programming Language) Influencing Without Authority Interdisciplinary Collaboration Non-Disclosure Agreement (Intellectual Property Law) +0

• Ph.D., with at least ten years of pharmaceutical drug development experience relating to: systems pharmacology, systems biology, PKPD, mathematics, chemical/biomedical engineering or related field.
• Masters or PharmD, with at least fifteen years of experience, where experience” means having a record of increasing responsibility and independence in a similar role 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 to 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 immune-axis will be preferred.
• Experience with modeling and simulation packages or programming languages (e.g., MATLAB, R, SimBiology, Python)
• Experience working with external QSP vendors.
• Experience in 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 application of mechanistic model-based approaches.
• Proficiency in written and verbal communication, interdisciplinary collaboration, and problem scoping and planning.

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

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.

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The salary range for this role is $210,400.00 - $331,100.00

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.