Associate Principal Scientist, Clinical Research

MSD • Boston, MA

1d • $142,400 - $224,100 • Hybrid

About The Position

The Early Clinical Scientist provides operational and scientific leadership for designing, planning, and executing early-phase clinical trials and programs in collaboration with the Clinical Director and cross-functional teams. The role oversees the strategic direction and execution of clinical trials, manages cross-functional team performance, and ensures compliance with GCP, ICH, and regulatory requirements while delivering high-quality data. It also includes clinical safety assessment and risk management, real-time oversight of ongoing trials, interpretation of trial data, and potential on-site monitoring and training at clinical sites for complex endpoint or biomarker collection processes.

The role represents Early-Stage Clinical Development on early and product development teams and may lead development of departmental job aids, SOPs, and global clinical development procedures. It identifies and communicates organizational best practices, supports adoption of new procedures, mentors junior team members, and may represent the company at professional events by presenting clinical initiatives, projects, or trial results.

Responsibilities include authoring clinical and regulatory documents, coordinating WMA/CTD subsections, and assisting Clinical Directors with scientific leadership, investigator initiatives, publications, presentations, and due diligence. The position develops study operational documents such as monitoring plans, study operations and laboratory manuals, risk language, and informed consents. It also leads study planning and execution activities, manages trial and program projects, facilitates team and governance meetings, prepares senior management presentations and advisory meetings, and provides risk assessments and contingency planning under accelerated timelines.

The position is based primarily in Rahway, New Jersey, with a hybrid work arrangement and 10% travel. Relocation is not offered. The role is a regular employee position.

Requirements

• At least 6 years of 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 navigate ambiguity to drive results.
• Ability to solve complex problems and exercise independent judgment concerning regulations, guidelines, and investigator interactions.
• Ability to rapidly develop working scientific knowledge in different therapeutic areas.
• Demonstrated excellence in complex project management and managing multiple projects and priorities.
• Ability to work effectively across organizational boundaries and apply an understanding of cultural differences to communication and collaboration.
• Demonstrated excellence in scientific, medical/safety writing, and reporting.
• Ability to work independently across functional areas, make data-driven decisions, identify and escalate potential issues, and plan mitigations.
• Proven ability to partner effectively with external teams.
• Effective written and oral communication, 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 addressing a business gap or process improvement.
• Must act with courage and candor.
• Degree in Life Sciences, with one of the following: bachelor's degree and at least 11 years of related experience; master's degree and at least 8 years of related experience; or PhD or doctorate degree and at least 3 years of related experience.
• Related experience examples include clinical trial management and execution, clinical site training or monitoring, and medical and regulatory writing.

Nice To Haves

• At least 6 years of Phase 1 clinical trial experience.
• Experience with global Phase 1 patient trials, safety reporting, and regulatory NDA/WMA submissions.
• An advanced degree is desirable.

Responsibilities

• Provide operational and scientific leadership for the design, planning, and execution of early-phase clinical trials and programs with Clinical Directors and cross-functional teams.
• Oversee the strategic direction and execution of clinical trials and programs, managing cross-functional team performance to meet trial objectives.
• Ensure execution excellence and compliance with GCP, ICH, and regulatory requirements, supporting study objectives and high-quality data delivery.
• Conduct appropriate clinical safety assessment and risk management, and provide real-time trial oversight to identify and mitigate participant, study design, data, or conduct issues.
• Review and interpret clinical trial data and potentially participate in on-site clinical-site monitoring, training, and supervision for complex endpoint or biomarker collection processes.
• Represent Early-Stage Clinical Development on early development and product development teams.
• Develop departmental job aids and SOPs and participate in or lead cross-functional teams developing global clinical development procedures.
• Identify and communicate best practices, promote adoption of new procedures, and coach and mentor junior team members.
• Potentially represent the company at professional events and present clinical initiatives, projects, or trial results.
• Author clinical protocols, investigator brochures, clinical study reports, health authority update reports, regulatory responses, audit and inspection responses, and other clinical and regulatory documents.
• Author and coordinate development of WMA/CTD subsections and ensure documents comply with applicable standards.
• Assist Clinical Directors with scientific leadership and investigator initiatives, publications, meeting presentations, and due diligence activities.
• Develop study operational documents, including site monitoring plans, study operations and laboratory manuals, risk language, and informed consents.
• Lead and direct teams through study planning and execution activities, including program overviews, issue escalation and mitigation, senior management presentations, governance meetings, and advisory meeting preparation.
• Manage trial and program projects, including team meetings and collaborative workspace and document management.
• Provide risk assessments and contingency planning under accelerated timelines.

Benefits

• Medical, dental, and vision healthcare benefits and other insurance benefits for employees and family.
• Retirement benefits, including 401(k).
• Paid holidays.
• Vacation.
• Compassionate and sick days.
• Eligible for annual bonus and long-term incentive, if applicable.

What This Job Offers

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