Clinical Director (Principal Scientist), Translational Medicine, Immunology

Job Overview Translational Medicine is responsible for early clinical development of novel therapeutics, working in close collaboration with Immunology Discovery Sciences and late‑stage Immunology Clinical Research. The role focuses on Immunology within the Research Division. The Principal Scientist (Medical Director level) must have a strong background in basic and/or clinical translational research and a desire to work collaboratively across therapeutic areas. Translational Medicine Responsibilities Lead the early clinical development strategy for novel therapy programs from preclinical candidate approval through clinical pharmacology testing (Phase 1) and clinical proof‑of‑concept (Phase 2). Develop biomarker strategies with cross‑functional teams to provide a line of sight from first‑in‑human studies through clinical proof‑of‑concept, including experimental medicine studies to establish and/or validate biomarker platforms. Contribute to identification of novel targets by partnering with discovery research teams and execute clinical studies to evaluate relevance to human disease, justifying investment in clinical development programs. Develop and execute clinical pharmacology strategies to support later stages of development from proof‑of‑concept (Phase 2) through worldwide marketing application. Primary Responsibilities Key member of an early development team, providing leadership in designing and executing early clinical development strategy. Develop and execute early clinical strategy for novel therapeutics, including authoring initial clinical and biomarker plans for lead optimization programs, early clinical development plans for preclinical candidate molecules, and clinical pharmacology studies for phases I‑IV. Develop and execute studies to validate clinical platforms utilizing established and novel biomarkers, including imaging, electrophysiological, and behavioral responses to interrogate biological activity in humans. Provide clinical expertise for identification and validation of novel targets, including design of preclinical and/or clinical pharmacology experiments. Ensure safe and timely execution of Phase I studies; collaborate with internal and external clinical study support staff and scientists. Provide clinical pharmacology support for programs through worldwide marketing application filing, including supportive registration documents and presentations. Provide clear, timely communication and interpretation of study results to governance, experts, and review committees. Contribute to assessment of internal and external opportunities identified by business development and licensing. Interface broadly with key functions across the organization throughout research sites worldwide. Education MD or MD/PhD Required Qualifications Proven track record in clinical medicine or clinical research, and background in biomedical research. Demonstrated record of scientific scholarship and achievement, including publications or presentations. Strong interpersonal, writing and presentation skills, and ability to function in a team environment. Preferred Qualifications Clinical board certification or eligibility. Prior experience in translational research and/or early clinical development. Proven track record in clinical care of patient populations or management of clinical problem‑solving. Required Skills Clinical development Clinical judgment Clinical research Clinical studies Clinical trials Clinical trial support Cross‑functional teamwork Early clinical development Immunology Intellectual curiosity Translational medicine Translational research EEO Statement 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, and relevant state acts. Salary Range $260,300.00 – $409,700.00. 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, and other insurance benefits for employee and family, retirement benefits (401(k)), paid holidays, vacation, compassionate and sick days. More information available at Hybrid Work Model Effective September 5, 2023, employees in office‑based positions in the U.S. will be working a hybrid work schedule consisting of three total days on‑site per week, Monday‑Thursday, with Friday designated as a remote‑working day, unless business‑critical tasks require an on‑site presence. Location and Work Authorization U.S. and Puerto Rico residents only. Requests for accommodations during the application or hiring process are accepted. #J-18808-Ljbffr Merck & Co.