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The Associate Director leads the operational planning, feasibility, and execution of clinical trials within the Tulisokibart program. They serve as the Clinical Trial Team lead, facilitating collaboration between internal stakeholders and external vendors to meet study objectives.
Requirements
Candidates must possess a Bachelor's degree with at least 9 years of relevant experience, or a Master's/PhD with commensurate experience in clinical drug development. Strong knowledge of GCP/ICH regulatory requirements and proven leadership in a matrix environment are essential.
Full job description
Job Description
This position participates in the strategy and leads the operational planning and execution of one or more clinical trials in our Tulisokibart program. 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
Strong knowledge of clinical research regulatory requirements (e.g., Good Clinical Practice (GCP) and International Council for Harmonisation (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 and 9+ years of pharmaceutical, clinical drug development, project management, and/or medical field experience -OR-
Master's Degree and 6+ years of pharmaceutical, clinical drug development, project management, and/or medical field experience -OR-
PhD/PharmD Degree and 2+ years of pharmaceutical, clinical drug development, project management, and/or medical field experience
Degree in life sciences, preferred
Ideal candidate would have:
Highly Preferred: experience in conducting clinical trials for Gastroenterology, Dermatology or Rheumatology, especially autoimmune or immune-mediated disorders
Experience in conducting global clinical trials, including trial initiation through database lock
Experience in managing and driving operational activities on protocols for immunology related clinical trials
clinicaltrialjobs
Required Skills:
Adaptability, Analytical Problem Solving, Clinical Development, Clinical Operations, Clinical Sciences, Conflict Management, Critical Thinking, Ethical Standards, Good Clinical Practice (GCP), Partner Relationship Management (PRM), People Management, Presentation Delivery, Process Improvements, Stakeholder Alignment, Strategic Thinking
Preferred Skills:
Leadership, Prioritization, Problem Solving, Study Management, Vendor Management
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:
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.
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:
No
Hazardous Material(s):
N/A
Job Posting End Date:
09/24/2026
*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:R415524
Related keywords
Clinical TrialsImmunologyTulisokibartClinical OperationsGCPICHProject ManagementDrug DevelopmentGastroenterologyDermatologyRheumatologyAutoimmune DisordersVendor ManagementRegulatory ComplianceStrategic PlanningCross-functional Team
At MSD, known as Merck & Co., Inc., Rahway, NJ, USA in the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.msd.com and connect with us on Facebook, Instagram, Twitter, and YouTube.
Offices: 90 E Scott Ave, Rahway, New Jersey 07065, US · 2000 Galloping Hill Road, Kenilworth, NJ 07033, US · Jalan Puteri 5/20, Puchong, Selangor 47100, MY · Clos du Lynx 5, Woluwe-Saint-Lambert, Brussels Region 1200, BE · Keilaranta 3, Espoo, Southern Finland 02150, FI
Animal FeedVeterinaryHealth CareData ManagementBiopharmaClinical TrialsBiotechnologyMedicalPharmaceuticalData Center Automation
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