Associate Principal Scientist, Clinical Research

Merck; Boston (MA); Híbrido; USD 142 000 - 224 000; Tempo integral

Resumo da oferta

Merck is seeking an Early Clinical Scientist to lead the design and execution of early-stage clinical trials. You will partner with Clinical Directors and cross-functional teams to drive trial objectives, data quality, and regulatory alignment.

You will oversee safety assessment, risk management, and real-time trial oversight, mentoring junior staff and shaping global development procedures. Hybrid work model in USA, with travel.

Qualificações

• Degree requirements include science background and related trial management experience.
• Advanced degrees preferred for higher seniority and leadership responsibilities.
• Experience with clinical trial management, trial execution, and regulatory interactions.

Responsabilidades

• Lead and oversee the design, planning, and execution of early-phase clinical trials and programs.
• Collaborate with Clinical Director and cross-functional teams to meet trial objectives.
• Ensure GCP/ICH compliance and safety risk management across studies.
• Provide mentorship and development opportunities to junior staff.
• Communicate study results and outcomes to internal and external stakeholders.

Conhecimentos

Clinical Development

Clinical Reporting

Clinical Research

Clinical Study Design

Clinical Trial Development

Clinical Trials Monitoring

Clinical Trials Operations

Data Reporting

GCP/ICH

Medical Writing

Multiple Therapeutic Areas

Patient Recruitment

Regulatory Management

Research Designs

Scientific Writing

Study Design

Trial Design

Formação académica

Degree in Life Sciences

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

Descrição da oferta de emprego

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 trials 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 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 clinical trials and programs. Manages cross-functional team performance to achieve trial objectives. 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 monitoring at clinical sites, including site training & supervision of complex, novel endpoint/biomarker collection processes. Represents Early-Stage Clinical Development on early development and product development teams. May lead development of departmental job aids/SOPs and participate in, or lead, 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 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

• Degree in Life Sciences.
• Bachelor’s degree and ≥11 years related* experience, OR
• Master’s degree and ≥8 years related* experience, OR
• PhD or doctorate degree and ≥3 years related* experience.
• e.g., clinical trial management and trial execution; clinical site training/monitoring; medical and regulatory writing

Required Experience And Skills

• At least 6 years clinical trial experience in a clinical scientist or clinical operations role.
• Experience developing, implementing, and managing clinical programs and trials to ensure efficient, timely execution against milestones.
• 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 (ECSs have opportunities to support programs and trials in any therapeutic area based on portfolio needs).
• Demonstrated excellence in complex project management and effectively managing multiple projects/priorities; work effectively across boundaries, applying an understanding of cultural differences to communication and collaboration practices.
• 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 escalation, 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.

Preferred Experience And Skills

• At least 6 years Phase 1 Clinical trial experience.
• Global Phase 1 patient trials, safety reporting, and regulatory NDA/WMA submission experience.
• An advanced degree is desirable.

Required Skills

Clinical Development, Clinical Reporting, Clinical Research, Clinical Study Design, Clinical Trial Development, Clinical Trials Monitoring, Clinical Trials Operations, Data Reporting, Good Clinical Practice (GCP), Medical Writing, Multiple Therapeutic Areas, Patient Recruitment, Procedure Manuals, Regulatory Management, Research Designs, Scientific Research, Scientific Writing, Study Design, Trial Design

US And Puerto Rico Residents Only

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

Requirements

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 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.

The primary location for this posting is: USA - New Jersey - Rahway

Where required by law, the compensation range for this role is provided below.

The salary range for the primary location of this role is: $142,400.00 - $224,100.00

This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of 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.

Additional location(s)

Please note the salary range above applies to the Primary Location of the position. Where a role has other listed locations, different compensation guidelines may apply. You may find the salary ranges for additional locations below. If the salary range is not listed for the location you are applying to, our Talent Acquisition team will provide further information to you relevant to your location.

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

Employee Status

Regular

Relocation

No relocation

VISA Sponsorship

No

Travel Requirements

10%

Flexible Work Arrangements

Hybrid

Shift

Not Indicated

Valid Driving License

No

Hazardous Material(s)

N/A

Job Posting End Date

10/19/2026