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About the Role
The Clinical Director (Principal Scientist) is responsible for the strategic planning and direction of clinical research activities for investigational compounds in Immunology, focusing on late-stage development. This role manages the entire clinical development cycle, from indication selection and study design to execution, analysis, regulatory filing, and publication.
Responsibilities
- Evaluate pre-clinical and translational work to generate early clinical development plans and Investigational New Drug applications.
- Provide clinical development support for business development assessments of external opportunities to expand the Immunology Pipeline.
- Develop clinical development strategies for investigational drugs and plan clinical trials, including design and operational plans.
- Monitor and manage the conduct of ongoing or new clinical trials for investigational drugs.
- Analyze and summarize clinical findings to support decisions on safety, efficacy, new drug applications, clinical study reports, and publications.
- Participate in internal and external research project teams relevant to compound development.
- Supervise the activities of Clinical Scientists in the execution of clinical studies.
- Collaborate with cross-functional experts in commercialization, regulatory affairs, statistics, and manufacturing.
- Inform senior leadership on the progress of company and competitor drug studies and expert opinions.
- Maintain awareness of scientific developments, new findings, and research methodologies in the area of expertise.
- Identify scientifically and operationally strong investigators for drug development.
- Establish collaborative relationships with external experts in Rheumatology diseases.
- Attend scientific meetings to maintain competency and awareness of research activities.
- Author detailed development documents, presentations, budgets, and position papers.
- Facilitate collaborations with external researchers globally.
- Travel on company business approximately 20% of the time to manage clinical research projects.
Requirements
- Minimum of 5 years of clinical and/or development experience (academia, clinical medicine, and/or corporate clinical development).
- Demonstrated record of scientific scholarship and achievement.
- Prior experience in design and execution of phase 2 or 3 clinical trials in rheumatologic diseases is preferred.
- Strong interpersonal skills.
- Ability to work collaboratively in a cross-functional team environment.
Skills
- Clinical Development
- Clinical Research
- Clinical Trial Planning
- Cross-Functional Teamwork
- Immunology
- Rheumatology
Location
- US and Puerto Rico Residents Only
Work Type
- Hybrid
- Regular
- Domestic Relocation
Experience Level
- Minimum of 5 years of clinical and/or development experience
Education Level
- M.D., D.O., M.D./Ph.D, or D.O./Ph.D.
Salary/Compensations
- $255,800.00 - $402,700.00
Benefits
- Eligible for annual bonus and long-term incentive, if applicable.
- 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.
About the Company
- Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA.
- Committed to inclusion, ensuring candidates can engage in a hiring process that exhibits their true capabilities.
- Embraces the value of bringing together talented, committed people with diverse experiences, perspectives, skills and backgrounds.
- Encourages colleagues to respectfully challenge one another’s thinking and approach problems collectively.
Equal Opportunity
- 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.
- Learn more about your rights, including under California, Colorado and other US State Acts.
- 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.