Associate Principal Scientist, Clinical Research

Job DescriptionTranslational 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 vaccine trials and programs. 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 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 & CommunicationsResponsible 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 ManagementLeads 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.Education Minimum Requirement: Degree in Life SciencesBachelor’s degree and 11 years related* experience, ORMaster’s degree and 8 years related* experience, ORPhD or doctorate degree and 3 years related* experience*e.g., clinical trial management and trial execution; clinical site training/monitoring; medical and regulatory writingRequired Experience and Skills: At least 6 years Phase 1 clinical trial experience or at least 8 years Phase 2-3 clinical trial experience.Experience developing, implementing, and managing vaccine clinical programs and trials to ensure efficient, timely execution against milestonesAbility to think creatively, explore novel ways of working, and comfortably navigate ambiguity to drive resultsAbility to solve complex problems and use independent judgment relating to regulations, guidelines, investigator interactionsAbility 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 practicesDemonstrated excellence in scientific, medical/safety writing, and reportingAbility 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 initiativeProven ability to partner effectively with external teams to achieve resultsEffective communication (written and oral), problem solving and analytical skillsWorking knowledge of GCP, ICH guidelines and regulatory requirementsAbility to mentor junior staffDemonstrated leadership or participation in a cross-functional initiative to address a business gap or process improvementMust act with courage and candorPreferred Experience and Skills – An advanced degree is desirable. Global Phase 1 trials, safety reporting, and regulatory NDA/WMA submission experience a plus.Required Skills: Clinical Development, Clinical Development, Clinical Protocols, Clinical Reporting, Clinical Research, Clinical Sciences, Clinical Site Management, Clinical Study Design, Clinical Trial Development, Clinical Trials Operations, Data Evaluation, Drug Research, Early Phase Clinical Trials, Ethical Compliance, Ethical Standards, Good Clinical Practice (GCP), Life Cycle Planning, Medical Writing, Meeting Facilitation, Multiple Therapeutic Areas, Patient Recruitment, Presentation Preparations, Project Team Management, Regulatory Compliance, Scientific Writing {+ 4 more}Preferred Skills: Current Employees apply HERECurrent Contingent Workers apply HEREUS 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. Please click here if you need an accommodation during the application or hiring process.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 RightsEEOC 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.Learn more about your rights, including under California, Colorado and other US State ActsThe salary range for this role is$142,400.00 - $224,100.00This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this 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 .You can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.San Francisco Residents Only:We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance OrdinanceLos 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 OrdinanceSearch Firm Representatives Please Read CarefullyMerck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.Employee Status: RegularRelocation:No relocationVISA Sponsorship:NoTravel Requirements:10%Flexible Work Arrangements:HybridShift:Not IndicatedValid Driving License:NoHazardous Material(s):N/AJob Posting End Date:09/22/2026*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. SummaryLocation: USA - New Jersey - Rahway; USA - Massachusetts - Boston (MA Parcel B Laboratory); USA - Pennsylvania - West Point; USA - California - South San Francisco (Grand Ave)Type: Full time Merck Sharp & Dohme