Senior Principal Scientist, Clinical Operations - Immunology

Job Description

Job Summary

-This position provides expert strategic, scientific, and operational leadership in the planning and execution of highly complex program(s) (e.g., spanning multiple disease areas/indications, involving large outcome trials). In this position, you will have the opportunity to lead and direct global, cross-functional teams in end-to-end clinical development activities (strategic planning through post-marketing approval). You will apply project management and organizational leadership expertise in our fast-paced, industry-leading, dynamic bio-pharmaceutical company.

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Core Responsibilities

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• Overarching responsibility and oversight of clinical program execution, providing innovative ideas to achieve organizational objectives.
• Lead and direct teams to support key program planning and execution elements (e.g., program level overviews; sr. management, and governance meetings; regulatory agency interactions; advisory meeting preparation). Serves as an escalation point for issues and promotes cross-function solutions.
• Apply expertise to maximize operational feasibility and efficiency. Ensure consistency and quality across assigned portfolio.
• Serve as the operational representative on the Product Development's Clinical Subteam.
• Contributes to resource planning and staffing (hiring and/or project onboarding; management of clinical scientists and/or study managers; may include management of program leads).
• Collaborate and facilitate interactions with key internal and external stakeholders (e.g., KOLs, suppliers and licensing partners) in support of clinical program objectives.
• Assist the Clinical Directors in scientific leadership/investigator initiatives including preparation of publications, meeting presentations.
• May lead and/or implement process improvement and strategic initiatives.
• May lead operational components of mergers and acquisitions (e.g., due diligence activities, portfolio integrations).
• Manages and provides feedback and developmental opportunities for direct reports and staff.

Core Skills

Demonstrated ability to drive and manage highly complex clinical program(s) (e.g., strategic planning through post-approval). This position may represent the company through external partnerships, collaborations, and key strategic engagements. This includes the ability to:

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• 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. Role requires proactive approach, strategic thinking, and leadership to envision, plan and execute organizational goals
• Makes decisions guided by profit plan or budget that impact support, resourcing and implementation of projects, programs and/or technologies. Demonstrated ability to effectively delegate work to meet the business needs
• Resolves complex technical, operational, and financial problems. Decisions guided by resource availability and department objectives. Ability to take a broader view of issues to maximize benefit and/or impact to the organization
• Has advanced understanding of end-to-end clinical research process
• Excellent writing and communication skills
• Demonstrated leadership skills in managing people, programs & processes, leading meetings and influencing peers and direct reports in a matrix environment
• Advanced problem solving, conflict resolution, and critical thinking skills
• Expert knowledge of GCP and ICH regulations
• Demonstrated project management, and time management/organizational skills
• Build team capabilities through proactive coaching
• Provide guidance to team members/colleagues for functional area deliverables with emphasis on consistent application of Therapeutic Area or program specific requirements
• Strong communication skills with advanced oral and written English skills
• Advanced computer/database skills

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The ideal candidate has:

• Experience managing direct reports
• Experience in conducting autoimmune and/or immune mediated diseases in gastroenterologic, rheumatologic and dermatologic diseases including but not limited to ulcerative colitis, rheumatoid arthritis, psoriasis, atopic dermatitis, etc.
• Conducted global phase I-V trials, inclusive.-
• Experience in regulatory filings (e.g. Agency responses, filing documents [e.g. clinical summary, clinical efficacy, clinical safety, etc.], etc.)
• Highly preferred:- Experience with CoPilot, MS Forms, and Power Automate

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Experience

• Bachelor's degree + 15 years OR Master's + 12 years OR PhD/PharmD + 8 years Pharmaceutical and/or clinical drug development experience.
• Degree in life sciences, preferred.

clinicaltrialjobs -

#EligibleforERP

Required Skills:
Adaptability, Adaptability, Business Development, Clinical Development, Clinical Programs, Clinical Research, Clinical Trials Monitoring, Cross-Functional Teamwork, Data Management, Drug Regulatory Affairs, Early Clinical Development, Ethical Standards, Exercises Judgment, Global Clinical Studies, Immunology, Innovation, Life Science, Medical Care, Mergers and Acquisitions (M&A), Oncology Drug Development, Patient Safety, Process Improvements, Project Management, Regulatory Compliance, Regulatory Submissions {+ 5 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
$210,400.00 - $331,100.00

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 .

You can apply for this role through (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:
No

Hazardous Material(s):
No

Job Posting End Date:
04/25/2026
*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.

Requisition ID: R386440