Geography Functional Lead Associate Director – Study Execution

Caraway TherapeuticsRahway, New Jersey, PennsylvaniaHybridFull-timePrincipal, 12–15+ yearsListed 1 hour ago

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About this role

Job Description

The Associate Director, Geography Lead oversees day-to-day data-management operations and resources within the assigned geography. The role ensures operational efficiency, compliance, and quality delivery, supports regional strategy and resourcing, and partners with other leaders to promote consistent practices and staff development across sites.

Strategic Leadership & Geographic Strategy:

- Oversee day-to-day data-management execution within the assigned geography; ensure efficiency, quality, compliance, and inspection readiness.
- Responsible to review and provide input on work performed by direct reports.
- Manage and develop local teams; align performance to GDMS (Global Data Management and Standards) standards and expectations; guide onboarding and technical skill-building.
- Partner with Portfolio & Resource Operations Specialist team on workload tracking, capacity/utilization, and operational metrics; support near-term forecasting and workload balance across studies/TAs (Therapeutic Areas).
- Ensure adherence to GDMS/GCTO (Global Clinical Trial Operation) processes and local regulatory requirements; drive consistent execution of GDMS ways of working.
- Partner with functional leads to align oversight and promote consistent ways of working across regions.
- Identify and escalate operational or compliance risks; support mitigation and preventive actions.
- Share lessons learned and best practices within the geography; support change initiatives.

People Management Responsibilities:

- Align teams around a clear direction; set clear objectives aligned to organizational goals; assign work and set priorities accounting for work-life balance sustainability.
- Conduct regular check-ins and annual reviews; coach for performance; provide recognition.
- Develop career plans; create growth opportunities and promotion cases; ensure appropriate training and mentoring.
- Lead recruiting and hiring and oversee performance management activities, including management of sensitive employee-relations matters in partnership with HR.
- Coordinate on-shore/off-shore and contingent resources; ensure role clarity and effective handoffs.
- Manage an operating budget and optimize spend against priorities.
- Coaches, inspires and empowers team members, creating the support structures and clarity needed for high performance.

Technical Skills:

- Proficiency in workload planning, resourcing systems, and performance metric tools.
- Familiarity with continuous improvement methodologies
- Understanding of audit processes and ability to contribute to audit readiness.
- Ability to implement and execute inspection-readiness practices in collaboration with Process & Quality partners.
- Demonstrated ability to drive high-quality clinical data collection design, validation and delivery in alignment with protocol requirements.
- Understanding of local and global regulatory requirements, including Good Clinical Practice guidelines and 21 CFR Part 11, and processes.

Non-Technical Skills and Knowledge:

- Exceptional communication and influencing skills, with the ability to engage and align stakeholders across functions, geographies, and levels to achieve shared objectives.
- Effective coach, mentor and developing direct reports and teams to ensure high-level of performance, achieving satisfaction through advancement of others.
- Strong stakeholder management and collaboration capabilities, fostering trust and effective partnerships to deliver consistent, high-quality outcomes.
- Demonstrated ability to lead through influence, motivating and guiding cross-functional and virtual teams without direct reporting authority.
- Highly adaptable and resilient, able to prioritize and perform effectively under pressure in a fast-changing environment.
- Works independently with accountability, exercising sound judgment and initiative while maintaining alignment with organizational priorities.
- Effective facilitator of decision-making, coordinating the work of others and driving timely resolution of complex issues.
- Fluent in English with excellent written and verbal communication skills, able to clearly convey complex or technical information to audiences.
- Demonstrated ability to drive large-scale change, embed innovation, and lead continuous improvement initiatives, while ensuring adoption of standardized, risk-based, and digital practices.

Enterprise Leadership Skills:

- Execution Excellence - Drives reliable, high-quality delivery within their team - developing core functional capabilities and KPI-driven measurement approaches (e.g., time-to-lock, query rates, error reduction) to track progress, improve outcomes, and support consistent, submission-ready outputs across studies.
- Strategic Planning - Thinks strategically within the assigned scope and gains alignment through collaborative stakeholder engagement and influence across development, clinical operations, regulatory, safety, and IT.
- Networking & Partnerships - Builds and sustains strategic internal and external relationships (cross-functional leaders, service providers, alliance partners, customers) within the assigned scope to advance functional area objectives.

Qualifications and Experience:

- Bachelor's degree in a Life Science, Management or a related field with a minimum of 8  years of experience in organizational management in Biopharma or related industry, which includes a minimum 2 years of people management experience; OR   Advanced degree in a Life Science, Management or a related field with a minimum of 4 years of experience in organizational management in Biopharma or related industry, which includes a minimum 2 years of people management experience.

#eligibleforERP #GDMS #ONEGDMS

Required Skills:
Business Alignment, Career Planning, Clinical Data Management, Clinical Trials, Competency Management, Data Analysis, Data Validation, Decision Making, Good Clinical Practice (GCP), Interpersonal Relationships, People Management, Regulatory Compliance, Stakeholder Management, Strategic Thinking

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:

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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.

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The primary location for this posting is:
USA - Pennsylvania - North Wales (Upper Gwynedd)

Where required by law, the compensation range for this role is provided below.

The salary range for the primary location of this role is:
$142,400.00 - $224,100.00

This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of 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 .

Additional location(s): Please note the salary range above applies to the Primary Location of the position. Where a role has other listed locations, different compensation guidelines may apply. You may find the salary ranges for additional locations below. If the salary range is not listed for the location you are applying to, our Talent Acquisition team will provide further information to you relevant to your location.

Additional location(s) Compensation Information:

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:
Hybrid

Shift:
1st - Day

Valid Driving License:
No

Hazardous Material(s):
N/A

Job Posting End Date:
10/26/2026
*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.