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Job Description

Role and Responsibilities:

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 toutilizemechanistic/ QSP modeling for doseselection, combinationstrategiesand 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.

Minimum education required:

• 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.

Required Experience:

• 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.

• Proficiencyin written and verbal communication, interdisciplinary collaboration, and problem scoping and planning.

Required Skills:

Preferred Skills:

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The remote position is only applicable for those that are not within commutable distance to primary sites noted in posting. If commutable, the position will be hybrid. Please note that standard commute is (less than) <50 miles.

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.

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:

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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

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.

We offer a comprehensive package of benefits. Available benefits include 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 https://jobs.merck.com/us/en/compensation-and-benefits.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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

Search Firm Representatives Please Read Carefully
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.

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