Associate Director, Study Manager (Immunology)

Job Description

This position participates in the strategy and leads the operational planning and execution of one or more clinical trials. In this position, you will have the opportunity to demonstrate your advanced leadership and technical skills as part of a global, cross-functional team. You will build and coach your team in the development of project management, communication, and collaboration skills in support of our clinical trials.

Job Responsibilities

• Responsible for the operational planning, feasibility, execution and conduct of clinical trial(s).

• Serves as the Clinical Trial Team lead.

• Leads and directs teams in key study planning, development, and execution elements (e.g. operational reviews, issue escalation/mitigations, presentations at Sr Management meetings, program level cross functional meetings and governance).

• Responsible for facilitating and collaborating with key internal/external stakeholders (study team, subsidiary country teams, vendors, committees, etc.) in support of clinical trial objectives.

• Liaises with partners, vendors, and vendor management team.

• Review and provide clinical operations input into relevant clinical documents such as the protocol and other documents as appropriate.

• May serve as a subject matter expert and/or participate on process improvement teams.

• Builds talent and capabilities of junior team members through proactive coaching, mentoring and development opportunities.

• May include management of direct/ indirect reports including assignment of resources, professional development, and performance management

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:  

• Strong knowledge of clinical research regulatory requirements (e.g., GCP and ICH)

• Proven ability to manage competing priorities and effectively delegate and assign activities to meet the business needs

• Ability to develop short and mid-range project plans that are realistic and effective at meeting goals.

• Strong analytical skills to drive operational milestones

• Influence opinions and decisions of internal and external customers/vendors, across functional areas, and within the division

• Interact with key stakeholders across department, division, and company. Roles requires a proactive approach, strategic thinking and leadership driving toward study goals.

• Demonstrated leadership skills in programs & processes, leading meetings and influencing peers and direct/indirect reports in a matrix environment.

• Problem solving, prioritization, conflict resolution, and critical thinking skills

• Strong communication, writing, and presentation skills

• Proficient knowledge in Microsoft office or similar (Excel, PowerPoint, Word, Outlook, etc.)

Education/Experience

• Bachelor's Degree +9 years of pharmaceutical, clinical drug development, project management, and/or medical field experience

• OR Master's Degree +6 year of pharmaceutical, clinical drug development, project management, and/or medical field experience

• OR PhD/PharmD Degree +2 year of pharmaceutical, clinical drug development, project management, and/or medical field experience

• Degree in life sciences, preferred.

• Experience in planning and executing clinical studies in ophthalmology highly preferred

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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, 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:

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.

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. 

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