Job Abstract

Job Description

The Early Clinical Scientist/ECS provides leadership and therapeutic expertise for the design, planning and execution of early phase clinical trials with the Clinical Director and internal/external team members. Responsible for oversight, strategic direction and implementation of multiple trials within and/or across program(s)/therapeutic areas and developmental stages. Ensures excellence in execution and compliance to support study objectives and data validity. Ensures consistency for all clinical program elements. 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 real-time oversight of ongoing trials to identify and mitigate patient, study design, data or study conduct issues. Reviews and interprets clinical trial data. May conduct on-site study monitoring, including site training & supervision of complex, novel endpoint/biomarker collection processes. Applies thorough knowledge of GCP, ICH guidelines and regulatory requirements for clinical development.

Represents Early Stage Development on early development and product development teams. Directs the development of departmental job aids/SOPs and participates in or leads cross-functional teams to develop global clinical development procedures. Identifies and communicates best practices within the organization. Promotes departmental adaptation of new procedures. Builds talent and capabilities of junior team members through proactive coaching, mentoring and development opportunities. Represents the company at professional events and may present company clinical initiatives, projects, and/or clinical trial results.

Technical Writing & Communications

Responsible for authoring of clinical protocols, clinical investigator brochures, clinical study reports, regulatory agency update reports, responses to regulatory agencies, responses to audits/inspections, and other clinical and regulatory documents. Author and coordinate the development of Worldwide Marketing Application/Common Technical Document (WMA/CTD) subsections. Assist the Clinical Directors in scientific leadership/investigator initiatives including preparation of publications, meeting presentations, due diligence activities, etc. 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

Leads and directs teams in key study planning, development and execution elements (e.g., program level overviews, issue escalation/mitigations, presentations at Sr. Management meetings, program level cross-functional meetings and governance, advisory meeting preparation). 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. Thorough understanding of early drug development processes, applying knowledge and skills to effectively manage additional processes/procedures.

Education Minimum Requirement:

• Degree in Life Sciences

• Bachelor’s degree and =11 years related* experience, OR

• Master’s degree and =8 years related* experience, OR

• PhD or doctorate degree and =3 years related* experience

• *e.g., familiarity with or 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).

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders).  Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

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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, generally Tuesday, Wednesday and either Monday or 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”.

Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. 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 salary range:

Available 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.

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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:

Relocation:

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Travel Requirements:

Flexible Work Arrangements:

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