Associate Principal Scientist, Clinical Research
Merck · United States, Pennsylvania, West Point
Job Description
Position Title (Short Title): Associate Principal Scientist
Department: Translational Medicine, Clinical Operations
Brief Description of Position:
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 clinical operational 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 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 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 adoptation 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.
- 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.
Project Management:
- 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.
Reports to
Director/Senior Principal Scientist/Distinguished Scientist
Location
WP/RY/BOS/SSF
Extent of Travel
~10%
Qualifications, Skills & Experience
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 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; experience with immunology early patient trials (eg, Phase 1b patient trials in rheumatology, dermatology, and/or gastroenterology) preferred.
- 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 other therapeutic areas 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 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.
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 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 {+ 5 more}
Preferred Skills:
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