USA - Pennsylvania - West Point, United States of America
Hybrid
Job Description
Translational Medicine (TMed) drives early clinical development of novel therapeutics by partnering with Discovery Sciences and Late-Stage Clinical Research to translate scientific discoveries into human proof-of-concept and advance the most promising candidates through the pipeline to patients. We design and execute clinical pharmacology strategies spanning first-in-human studies through proof-of-biology/proof-of-concept and into late-stage development, supporting worldwide marketing applications and lifecycle management.
The Early Clinical Scientist (ECS) provides operational and scientific leadership, along with therapeutic expertise, for the design, planning, and execution of early-phase clinical trials and programs in collaboration with the Clinical Director and cross-functional teams. Accountable for the oversight, strategic direction, and execution of Immunology programs including multiple Phase 1 and 1b trials across programs and developmental stages. Manages cross-functional team performance to achieve trial objectives and addresses issues if they arise. Ensures execution excellence and compliance with GCP, ICH, and regulatory requirements, supporting study objectives and the delivery of high-quality data.
Ensures appropriate clinical safety assessment and risk management of compounds, and provides real-time oversight of ongoing trials to identify and mitigate participant, study design, data, or study conduct issues. Reviews and interprets clinical trial data and may participate in on-site study monitoring, including site training & supervision of complex, novel endpoint/biomarker collection processes.
Represents Early Stage Development on early development and product development teams. Leads the development of departmental job aids/SOPs and participates in, or leads, cross-functional teams developing global clinical development procedures. Identifies and communicates best practices across the organization. Promotes departmental adaptation of new procedures and builds junior team members’ capabilities through proactive coaching, mentoring, and development opportunities. May represent the company at professional events. present clinical initiatives, projects, and/or clinical trial results.
Technical Writing & Communications
Responsible for authoring clinical protocols, investigator brochures, clinical study reports, health authority update reports, responses to regulatory agencies and audits/inspections, and other clinical and regulatory documents. Authors and coordinates the development of WMA/CTD subsections. Assist Clinical Directors with scientific leadership and investigator initiatives, including publications, meeting presentations, and due diligence activities. Ensures documents are completed in accordance with applicable standards. Develops study operational documents with input from team members, including site monitoring plans, study operations/laboratory manuals, risk language, and informed consents.
Project Management
Leads and directs teams through key study planning, development, and execution activities, including program overviews, issue escalation and mitigation, senior management presentations, cross-functional governance meetings, and advisory meeting preparation. Manages trial and program projects, including team meetings and collaborative workspace/document management, while providing risk assessments and contingency planning under accelerated timelines.
Education Minimum Requirement:
*e.g., clinical trial management and trial execution; clinical site training/monitoring; medical and regulatory writing
Required Experience and Skills:
Preferred Experience and Skills – An advanced degree is desirable. Global Phase 1 patient trials, safety reporting, and regulatory NDA/WMA submission experience a plus.
Required Skills:
Biomarker Assay Development, Biomarker Assay Development, Clinical Development, Clinical Reporting, Clinical Research, Clinical Risk Management, Clinical Site Management, Clinical Study Design, Clinical Trials, Clinical Trials Operations, Detail-Oriented, Due Diligence, Early Clinical Development, Ethical Compliance, Ethical Standards, Good Clinical Practice (GCP), Immunogenicity Assays, Immunology, Job Aids, Medical Writing, Multiple Therapeutic Areas, Patient Recruitment, Regulatory Requirements, Regulatory Responses, Scientific Leadership {+ 2 more}Preferred Skills:
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US and Puerto Rico Residents Only:
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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:
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.
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The salary range for this role is
$142,400.00 - $224,100.00This 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 paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
RegularRelocation:
No relocationVISA Sponsorship:
NoTravel Requirements:
10%Flexible Work Arrangements:
HybridShift:
Not IndicatedValid Driving License:
NoHazardous Material(s):
N/AJob Posting End Date:
07/15/2026*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
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