Associate Director, Quantitative Pharmacology and Pharmacometrics – Immuno-Oncology (QP2‑IO)

Job description

Job Description Our company is a global healthcare leader with a diversified portfolio of prescription medicines, vaccines, and animal health products. We are recognized as an industry leader in immuno-oncology (IO) and vaccines discovery and development. For more than a century, our company has translated scientific innovation into medicines and vaccines that improve and save lives worldwide—anchored in ethical integrity, scientific excellence, and a clear mission to transform global health. Our company is on a quest for cures and is committed to being the world’s premier, most research-intensive biopharmaceutical company. Our Research & Development Division is a world-class scientific organization that brings together leading discovery capabilities and small molecule/biologics R&D expertise to create breakthrough science and redefine how we treat serious diseases. Role Overview We are seeking an experienced talented scientist to join the Quantitative Pharmacology and Pharmacometrics – Immune/Oncology (QP2-IO) team in the role of Associate Director 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. Associate Directors are emerging leaders in the field of quantitative drug development, with a developing understanding of the strategic elements of drug development and effective communication skills. As a subject matter expert, the Associate Director within the QP2-IO Group will work closely with teams of highly collaborative, cross-functional scientists to contribute to development of novel chemical entities. They develop strategies for quantitative analyses (and commensurate experiments/trials) within and across development programs and/or functions. 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 on drug development teams. Primary Responsibilities: Serving as an expert representative for QP2-IO on Oncology clinical development teams. Framing critical questions 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 simulation, disease progression models, quantitative systems pharmacology (QSP) modeling, comparator modeling, thereby strengthening pharmacometrics capabilities on a continuous basis in decision making and driving pipeline impact. Strategizing and executing modeling of tumor size and survival endpoints including proportional hazards models. 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. Minimum EducationPh.D. with at least 3 years of experience OR PharmD or MS or equivalent degree with preferably 5-7 years of relevant experience, where “experience” means having a record of increasing responsibility and independence in a similar role in pharmaceutical drug development. Required Experience and SkillsDemonstrated impactful experience with applications of pharmacometrics methods. Skills in experimental design, mathematical problem solving, critical data analysis/interpretation, and statistics. Proficiency in R, NONMEM or other similar programing language. Professional working proficiency in written and verbal communication. This opportunity will be hybrid or remote, but 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." #QP2 #EligibleforERP Required Skills: Clinical Development, Clinical Pharmacology, Communication, Data Modeling, Dose Response Analysis, Drug Development, Machine Learning (ML), Model Driven Development, Modeling Simulations, Modeling Software, Pharmaceutical Development, Pharmacometrics, Stakeholder Relationship Management Preferred Skills: NONMEM, Oncology, Oncology Drug Development, Phoenix WinNonlin, PKPD Modeling, Population Pharmacokinetics, Regulatory Writing Current Employees apply HERE Current Contingent Workers apply HERE 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: EEOC Know Your Rights EEOC GINA Supplement​ 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. Learn more about your rights, including under California, Colorado and other US State Acts The salary range for this role is $156,900.00 - $247,000.00 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. 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 pai