Scientist, Translational Medicine (Hybrid)
Scientist, Translational Medicine (Hybrid)
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$ 85600 - 134800
1 Vacancy
Job Description
Job Description
Our company is a global health care leader with a diversified portfolio of prescription medicines vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where our company has codified its legacy for over a century. Our companys success is backed by ethical integrity forward momentum and an inspiring mission to achieve new milestones in global healthcare.
Translational Medicine is responsible for early clinical development of novel therapeutics working in close collaboration with Discovery Sciences and latestage Clinical Research across all therapeutic areas. Our team is focused on innovation and dedicated to translating breakthrough science into innovative medicines that extend and improve the lives of patients worldwide. Through clinical trials we ensure the safety and efficacy of our pipeline and existing products to produce safe effective innovative medicine.
The Early Clinical Scientist/ECS coordinates the design planning and execution of early phase clinical trials with the Clinical Director and internal/external team members. Oversees trials within and/or across program(s)/therapeutic areas. Ensures excellence in execution/compliance to support study objectives and data validity. Manages internal/external team performance to achieve project objectives and resolves project performance issues if they arise.
Ensures appropriate clinical safety assessment and risk management of compounds. Conducts realtime oversight of ongoing trials to identify and mitigate patient study design data or study conduct issues. Reviews and interprets clinical trial data. May conduct onsite study monitoring including site training & supervision of complex novel endpoint/biomarker collection processes. Applies knowledge of GCP ICH guidelines and regulatory requirements for clinical development.
Contributes to teams developing and/or improving internal job aids/SOPs. Identifies and communicates best practices within the organization.
Technical Writing & Communications
Coauthors clinical sections of protocols clinical investigator brochures clinical study reports Worldwide Marketing Application/Common Technical Document (WMA/CTD) subsections and regulatory agency updates and safety reports as well as clinical development plans publications and abstracts. Ensures documents are completed in accordance with applicable standards. Develops study operational documents with input from team members (e.g. site monitoring plan study operations manual informed consent etc.).
Project Management
Manages trial and program projects including team activities (i.e. meetings document/collaborative workspace management etc.) provides risk assessment and contingency planning under accelerated timelines. Familiar with early drug development processes building knowledge and skills to effectively manage additional processes/procedures.
Education Minimum Requirement:
Degree in Life Sciences
Bachelors degree and 4 years related* experience OR
Masters degree or higher and 1 years related* experience
*e.g. knowledge of clinical trial management and trial execution; clinical site training/monitoring; medical and regulatory writing; OR equivalent experience with developing preclinical model experiments for drug candidates (protocol authoring experiment execution/oversight authoring experiment reports).
Required Experience and Skills:
Understanding of clinical research development process from program planning to regulatory submission
Able to quickly develop a working scientific knowledge of different therapeutic areas
Ability to manage complex operations and projects under accelerated timelines
Scientific medical and/or safety writing and reporting (at least one is required)
Ability to partner effectively with internal and external teams to achieve results
Strong team collaboration leadership communication (written and verbal) issue identification and resolution skills
Knowledge of GCP ICH guidelines and regulatory requirements
Preferred Experience and Skills Global Phase I subject and patient trials & safety reporting experience a plus.
#eligibleforerp
Current Employees apply HERE
Current Contingent Workers apply HERE
US 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 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:
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 anothers thinking and approach problems collectively.
Learn more about your rights including under California Colorado and other US State Acts
U.S. Hybrid Work Model
Effective September 5 2023 employees in officebased positions in the U.S. will be working a Hybrid work consisting of three total days onsite per week Monday Thursday although the specific days may vary by site or organization with Friday designated as a remoteworking day unless business critical tasks require an onsite Hybrid work model does not apply to and daily inperson attendance is required for fieldbased positions; facilitybased manufacturingbased or researchbased positions where the work to be performed is located at a Company site; positions covered by a collectivebargaining 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 candidates relevant skills experience and education.
Expected US salary range:
$85600.00 $134800.00Available 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 listed here.
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
Search Firm Representatives Please Read Carefully
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 preexisting 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:
1st DayValid Driving License:
NoHazardous Material(s):
N/ARequired Skills:
Preferred Skills:
Job Posting End Date:
05/22/2025*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.
Employment Type
Full-Time
