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About the Role

Translational Medicine drives early clinical development of novel therapeutics by partnering with Discovery Sciences and Late-Stage Clinical Research. The Early Clinical Scientist (ECS) provides clinical operational leadership for the design, planning, and execution of early-phase clinical trials and programs. This role is accountable for the execution of Immunology programs, including multiple Phase 1 and 1b trials, ensuring execution excellence and compliance with GCP, ICH, and regulatory requirements.

Responsibilities

Provides clinical operational leadership for the design, planning, and execution of early-phase clinical trials and programs.
Accountable for the 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.
Provides real-time oversight of ongoing trials to identify and mitigate participant, study design, data, or study conduct issues.
Reviews 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 Clinical Operations 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 adoption 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.
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.
Develops study operational documents with input from team members, including site monitoring plans, study operations/laboratory manuals, risk language, and informed consents.
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.
Leads, directs, or supports 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.

Requirements

At least 3 years Phase 1 clinical trial experience.
Experience developing, implementing, and managing immunology clinical programs and trials in healthy participants and/or patients to ensure efficient, timely execution against milestones under accelerated timelines.
Ability to think creatively, explore novel ways of working, and comfortably navigate ambiguity to drive results.
Ability to solve complex problems and use independent judgment relating to regulations, guidelines, investigator interactions.
Ability to quickly develop a working scientific knowledge of different therapeutic areas.
Demonstrated excellence in complex project management and effectively managing multiple projects/priorities.
Demonstrated excellence in scientific, medical/safety writing, and reporting.
Ability to independently work across functional areas to make data-driven decisions as well as proactively identify, appropriately escalate, and plan for mitigations to potential issues within a study, program or initiative.
Proven ability to partner effectively with external teams to achieve results.
Effective communication (written and oral), problem solving and analytical skills.
Working knowledge of GCP, ICH guidelines and regulatory requirements.
Ability to mentor junior staff.
Demonstrated leadership or participation in a cross-functional initiative to address a business gap or process improvement.
Must act with courage and candor.
Global Phase 1 patient trials, safety reporting, and regulatory NDA/WMA submission experience a plus.
Domestic relocation is offered.
No VISA sponsorship is available.

Skills

Biomarker Assay Development
Clinical Development
Clinical Reporting
Clinical Research
Clinical Site Management
Clinical Study Design
Clinical Trial Development
Clinical Trials Operations
Contingency Plan
Early Phase Clinical Trials
Enterprise Leadership
Ethical Compliance
Ethical Standards
Good Clinical Practice (GCP)
Independent Thinking
Life Science
Medical Writing
Meeting Facilitation
Multiple Therapeutic Areas
Non-Disclosure Agreements
Patient Recruitment
Presentation Preparations
Project Management Leadership
Regulatory Compliance

Location

USA - Pennsylvania - West Point
WP/RY/BOS/SSF

Work Type

Hybrid
Regular

Experience Level

Associate Principal Scientist
Bachelor’s degree and ≥11 years related experience
Master’s degree and ≥8 years related experience
PhD or doctorate degree and ≥3 years related experience

Education Level

Degree in Life Sciences
Bachelor’s degree
Master’s degree
PhD or doctorate degree

Salary/Compensations

$142,400.00 - $224,100.00

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, is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities.
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.

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