About the Role
Direct strategic planning and execution of clinical research activities for investigational immunology compounds, focusing on late-stage development and managing the full clinical development cycle from study design to 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 (design, operational plans, settings).
- Monitor and manage the conduct of ongoing or new clinical trials for investigational drugs.
- Analyze and summarize clinical findings from studies to support safety, efficacy decisions, new drug applications, clinical study reports, or publications.
- Participate in internal and joint internal/external research project teams for new compound development.
- Supervise 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 the Executive Director in informing Corporate personnel about study progress for company and competitor drugs, and expert opinions on scientific questions.
- Maintain awareness of scientific developments, new scientific findings, and research methodologies within the area of expertise.
- Identify scientifically and operationally strong investigators to assist in developing investigational immunology drugs.
- Establish collaborative relationships with external experts in Rheumatology, Gastroenterology, Dermatology, Pulmonary, or rare diseases.
- Attend appropriate scientific meetings to maintain competency and awareness of research activities.
- Author detailed development documents, presentations, budgets, and position papers for internal and external audiences.
- Facilitate collaborations with external researchers globally.
- Travel on company business approximately 20% of the time to manage clinical research projects.
Requirements
- Experience in the design and/or execution of phase 2 or 3 clinical trials specifically in Immunology
- Minimum of 3 years of clinical medicine experience
- Minimum of 5 years of industry experience in drug development
- Demonstrated record of scientific scholarship and achievement
- Strong interpersonal skills
- Ability to work collaboratively in a cross-functional team environment
Skills
- Clinical Development
- Clinical Documentation
- Clinical Immunology
- Clinical Judgment
- Clinical Medicine
- Clinical Research Management
- Clinical Sciences
- Clinical Studies
- Clinical Trial Development
- Data Analysis
- Drug Development
- Hiring
- Ophthalmology
- Rare Diseases
- Scientific Consulting
- Strategic Planning
Location
- US
- Puerto Rico
- San Francisco
- Los Angeles
Work Type
- Regular
- Full-time
- Hybrid
Experience Level
- Minimum of 3 years of clinical medicine experience
- Minimum of 5 years of industry experience in drug development
Education Level
- M.D.
- D.O.
- M.D./Ph.D
- D.O./PhD
Salary/Compensations
- $282,200.00 - $444,200.00
- Eligible for annual bonus and long-term incentive, if applicable
Benefits
- Comprehensive package of benefits
- Medical healthcare benefits
- Dental healthcare benefits
- Vision healthcare benefits
- Other insurance benefits (for employee and family)
- Retirement benefits, including 401(k)
- Paid holidays
- Vacation
- Compassionate days
- Sick days
About the Company
- A global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products.
- Codified a legacy for over a century through innovation and inventiveness.
- Success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.
- Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA.
Equal Opportunity
- Committed to inclusion, ensuring candidates can engage in a hiring process that exhibits their true capabilities.
- As an Equal Employment Opportunity Employer, provides equal opportunities to all employees and applicants for employment.
- Prohibits 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, complies with all affirmative action requirements for protected veterans and individuals with disabilities.
- Provides information about personal rights under the U.S. Equal Opportunity Employment laws (EEOC Know Your Rights, EEOC GINA Supplement).
- 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.
- Provides information about rights under California, Colorado, and other US State Acts.
- For San Francisco Residents Only: Considers qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance.
- For Los Angeles Residents Only: Considers for employment all qualified applicants, including those with criminal histories, consistent with applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.
