Associate Principal Scientist, Clinical Operations - Immunology

Job Description

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

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.

Ideal candidate would have:

• Experience in conducting global clinical trials, including trial initiation through database lock.

• Highly Preferred: experience in conducting clinical trials for Gastroenterology, Dermatology or Rheumatology, especially autoimmune or immune-mediated disorders.

• Experience in developing protocols and study related documents for Immunology related clinical trials

• Experience with review of participant eligibility for trials (e.g., inclusion and exclusion criteria and prohibited/concomitant medications) with a high focus in Immunology related clinical trials.

• Experience in performing medical monitoring in Immunology related clinical trials.

clinicaltrialjobs  

EligibleforERP

Required Skills:

Accountability, Accountability, Adaptability, Analytical Problem Solving, Clinical Data Interpretation, Clinical Data Management, Clinical Immunology, Clinical Operations, Clinical Research, Clinical Study Design, Clinical Study Management, Clinical Trials, Clinical Trials Operations, Conflict Resolution, Data Analysis, Dermatology, Drug Development, Ethical Standards, Good Clinical Practice (GCP), Health Literacy, Innovation, Machine Learning (ML), Medical Writing, People Management, Prioritization {+ 4 more}

Preferred Skills:

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 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:

EEOC Know Your Rights

EEOC GINA Supplement​

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 another’s 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 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 salary range for this role is

$142,400.00 - $224,100.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits.  Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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 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:

Not Applicable

Shift:

1st - Day

Valid Driving License:

Yes

Hazardous Material(s):

No

Job Posting End Date:

04/13/2026

*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.