Description

Job Description

Job Summary

This position drives scientific planning, strategy and execution of Phase 1-4 clinical studies. Under the direction of the Program Lead, you will collaborate with global, cross-functional team members including clinical directors and study managers to lead/support clinical trial scientific activities.

Job Responsibilities

• Responsible for the clinical/scientific execution of clinical protocol(s).
• Serves as the lead clinical scientist on the clinical trial team.
• Collaborates with the Medical Writer on clinical/scientific and regulatory documents.
• Partners with Study Manager on study deliverables.
• Participates in the set up and design during study start up (e.g., database set up)
• Lead medical monitoring team in review and interpretation of clinical data/medical protocol deviations in collaboration with the Clinical Director.
• Builds talent and capabilities of direct/indirect team members through proactive coaching, mentoring and development opportunities.
• May include management of direct reports including assignment of resources, professional development, and performance management.
• May serve as a subject matter expert and/or participate on process improvement teams.

Core Skills

Demonstrated ability to drive and manage scientific activities on clinical protocols. This position may represent the company through external partnerships, collaborations, and key strategic engagements. This includes the ability to:

• Apply strong knowledge of clinical research regulatory requirements (e.g., GCP and ICH)
• Manage multiple competing priorities with good planning, time management and prioritization skills
• Advanced analytical skills with the ability to interpret clinical trial data and synthesize conclusions
• Interact with key stakeholders across department, division, and company.
• Role requires a proactive approach, strategic thinking and leadership driving toward study goals.
• Influence opinions and decisions of internal and external customers/vendors, across functional areas, and within the division
• Demonstrated ability to effectively delegate and assign activities to meet the business needs
• Problem solving, prioritization, conflict resolution, and critical thinking skills
• Build team capabilities through proactive coaching
• Advanced communication, technical writing, and presentation skills

Experience

• Bachelor's degree + 9 years OR Master's + 6 years OR PhD/PharmD + 2 years Pharmaceutical and/or clinical drug development experience. 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 gastrointestinal or rheumatologic diseases, preferably autoimmune/immune mediated disease trials.
• Experience in leading cross-functional teams responsible for data review of a clinical trial(s)
• Experience with external expert review of participant eligibility (e.g., QC inclusion and exclusion criteria)

Candidates with the following experiences/expertise are preferred, but not required:

• Experience with imaging vendors, eCOA, biomarker sample collection and management, and external data monitoring committee
• Overseeing a CRO conducted clinical trial from the Sponsor perspective
• Managing other scientists directly supporting the clinical trial

MRLGCTO

CSSMHiring

CSSMGenMed

#eligibleforERP

NOTICEFORINTERNALAPPLICANTS

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 separationpackage, 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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We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. 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, 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 City, 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:
$130,960.00 - $206,200.00

Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here.

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 pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Employee Status:
Regular

Relocation:
No relocation

VISA Sponsorship:
No

Travel Requirements:
10%

Flexible Work Arrangements:
Hybrid, Remote Work

Shift:
Not Indicated

Valid Driving License:
No

Hazardous Material(s):
n/a

Requisition ID:R252238