Associate Principal Scientist, Clinical Research

Merck • Boston, MA

1d • $142,400 - $224,100 • Hybrid

About The 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 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.

Requirements

• At least 6 years early phase/translational medicine clinical research experience
• Experience developing, implementing, and managing immunology clinical programs and trials to ensure efficient, timely execution against milestones, including experience with immunology early patient trials (eg, Phase 1b in rheumatology, dermatology, and/or gastroenterology) 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 (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

Nice To Haves

• An advanced degree is desirable.
• Global Phase 1 patient trials, safety reporting, and regulatory NDA/WMA submission experience a plus.

Responsibilities

• 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.
• 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.
• 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.

Benefits

• medical, dental, vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days

What This Job Offers

• Job Type: Full-time
• Career Level: Principal