United States onlyJob Description
Job Summary
This position leads the scientific planning and execution of one or more clinical trials or significant aspects thereof. In this position, you will have the opportunity to demonstrate your leadership, technical skills, and scientific acumen as part of a global, cross-functional team.
Job Responsibilities
Responsible for leading specific aspects of clinical/scientific execution of clinical protocol(s). This may include:
Serving as the lead clinical scientist on the clinical trial team.
Leading medical monitoring team in review and interpretation of clinical data/medical protocol deviations in collaborations with the Clinical Director.
Other responsibilities include:
Collaborating cross-functionally in the development of Protocol and related study materials (e.g., ICF documents / amendments); Partners with the Study Manager on study deliverables.
Ensuring CRF design supports data collection in alignment with the protocol in collaboration with Data Management/Programming.
Collaborating cross-functionally to monitor clinical data to ensure quality, completeness, and integrity of trial conduct.
Providing tactical/scientific mentorship to other clinical scientists.
Core Skills
Solid knowledge of clinical research regulatory requirements (e.g., GCP and ICH)
Ability to manage multiple competing priorities with good planning, time management and prioritization skills
Strong analytical skills with the ability to interpret clinical trial data and synthesize conclusion
Interact with key stakeholders across department, division, and company.
Role requires a proactive approach, strategic thinking and leadership in driving toward study goals.
Influence opinions and decisions of internal and external customers/vendors, across functional areas, and within the division
Applying leadership skills to processes, leading meetings, and influencing peers in a matrix environment.
Problem solving, prioritization, conflict resolution, and critical thinking skills
Build team capabilities through proactive coaching
Strong communication, technical writing, and presentation skills
Experience
Bachelor’s degree + 5 years of pharmaceutical, clinical drug development, project management, and/or medical field experience OR
Master’s + 3 years of pharmaceutical, clinical drug development, project management, and/or medical field experience OR PhD / PharmD.
Degree in life sciences, preferred.
Ideal candidate would have:
Experience in conducting global clinical trials, including trial initiation through database lock.
Experience in conducting clinical trials in rheumatologic disorders, preferably autoimmune/immune mediated disease trials.
Experience with review of participant eligibility for trials (e.g., inclusion and exclusion criteria)
Candidates with the with the following experiences/expertise are preferred, but not required:
Experience with imaging vendors, clinical outcome assessments, biomarker sample collection and management, and external data monitoring committee.
Managing other scientists directly supporting the clinical trial
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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:
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U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.
The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.
Expected US salary range:
$114,700.00 - $180,500.00Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listedhere.
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
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Merck & 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:
05/6/2025*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
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