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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 grow the Immunology Pipeline.
- Develop clinical development strategies for investigational drugs and plan clinical trials based on these strategies.
- Monitor and manage the conduct of ongoing or new clinical trials for investigational drugs.
- Analyze and summarize clinical findings to support decisions regarding safety, efficacy, new drug applications, clinical study reports, and publications.
- Participate in internal and joint internal/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 to manage clinical development projects.
- Assist leadership in informing corporate personnel about the progress of company and competitor drugs and expert opinions on scientific questions.
- Maintain awareness of scientific developments, research methodologies, and new scientific findings.
- Identify scientifically and operationally strong investigators to assist in 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 worldwide.
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.
- Compliance with San Francisco Fair Chance Ordinance for arrest and conviction records.
- Compliance with Los Angeles Fair Chance Initiative for Hiring Ordinance for criminal histories.
Skills
- Allergy and Immunology
- Clinical Development
- Clinical Immunology
- Clinical Research
- Clinical Trials
- Dermatology
- Drug Investigation
- Immunology
- Statistics
- Strategic Planning
Location
- US and Puerto Rico Residents Only
- San Francisco
- Los Angeles
Work Type
- Hybrid
- Regular
- Domestic Relocation
- VISA Sponsorship
Experience Level
- 5 years of clinical and/or development experience
Education Level
- M.D., D.O., M.D./PhD, or D.O./PhD
Salary/Compensations
- $255,800.00 - $402,700.00
- Eligible for annual bonus and long-term incentive
Benefits
- 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, and 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.
- Learn more about your rights, including under California, Colorado and other US State Acts.