Associate Director, Technical Project Management

MSD • Rahway, NJ

3d • Hybrid

About The Position

The Associate Director, Project Management — Pharma IT leads and delivers complex IT programs that support pharmaceutical research, development, manufacturing, and commercial operations. This role combines technical program leadership, regulatory awareness (GxP), vendor and stakeholder management, and people leadership to ensure IT initiatives are delivered on time, within scope, on budget, and compliant with applicable regulations and quality standards. Key responsibilities Lead a portfolio of Pharma IT projects from initiation through closeout, including GxP systems (LIMS, ELN, clinical trial systems, manufacturing execution systems, data platforms), infrastructure, integrations, and digital transformation efforts. Define and enforce project governance, SDLC and validation-related processes, and reporting cadence; adapt and champion delivery methodologies (Agile, Waterfall, hybrid) appropriate to regulated environments. Develop comprehensive project plans, resource and capacity forecasts, risk and issue logs, dependency maps, and change-control processes aligned with quality and regulatory requirements. Oversee requirements management, vendor selection, contract execution, and third-party validation activities; coordinate with QA and validation teams to ensure compliance. Provide strong stakeholder engagement across R&D, Clinical, Manufacturing, Regulatory Affairs, Quality, IT Security, Data Governance, and Commercial functions; communicate status, risks, mitigation plans, and decision-ready options to senior leadership and steering committees. Manage financial aspects of projects: budget creation, tracking, variance analysis, and forecasting; ensure cost controls and value realization. Mentor, coach, and develop project managers and technical leads; establish clear performance expectations and career development plans. Lead risk management and contingency planning, including cybersecurity risk assessments and business continuity considerations for critical systems. Drive continuous improvement in project delivery, including lessons learned, metrics, and process optimization tied to compliance and quality outcomes. Facilitate regulatory readiness activities and audit support, prepare project artifacts for inspections, and ensure traceability of requirements, design, testing, and release records.

Requirements

• Bachelor’s degree in information technology, Computer Science, Engineering, Life Sciences, or related field.
• 5+ years of progressive IT project/program management experience, with at least 3 years in a leadership role in pharmaceutical or life sciences IT.
• Demonstrated experience delivering GxP-regulated systems, clinical systems (e.g., CTMS, eTMF), laboratory systems (LIMS, ELN), manufacturing systems (MES), or enterprise data platforms.
• Experience with both Agile and Waterfall methodologies and practical experience applying hybrid approaches in regulated projects.
• Proven vendor management experience with CROs, system integrators, and SaaS providers in pharma contexts.
• Excellent communication skills; experience presenting to senior leaders and supporting inspection/audit readiness.
• Strong financial acumen and experience managing project budgets and forecasting.
• Accountability
• Communication
• Measurement Analysis
• Portfolio, Programme, and Project Support
• Program Management
• Risk Management
• Stakeholder Relationship Management
• Team Management
• Waterfall Model

Nice To Haves

• PMP, PgMP, PMI-ACP, or equivalent project/program management certification.
• Certifications or training in GxP compliance, IT validation, or regulatory affairs are a plus.
• 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
• 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.

Responsibilities

• Lead a portfolio of Pharma IT projects from initiation through closeout, including GxP systems (LIMS, ELN, clinical trial systems, manufacturing execution systems, data platforms), infrastructure, integrations, and digital transformation efforts.
• Define and enforce project governance, SDLC and validation-related processes, and reporting cadence; adapt and champion delivery methodologies (Agile, Waterfall, hybrid) appropriate to regulated environments.
• Develop comprehensive project plans, resource and capacity forecasts, risk and issue logs, dependency maps, and change-control processes aligned with quality and regulatory requirements.
• Oversee requirements management, vendor selection, contract execution, and third-party validation activities; coordinate with QA and validation teams to ensure compliance.
• Provide strong stakeholder engagement across R&D, Clinical, Manufacturing, Regulatory Affairs, Quality, IT Security, Data Governance, and Commercial functions; communicate status, risks, mitigation plans, and decision-ready options to senior leadership and steering committees.
• Manage financial aspects of projects: budget creation, tracking, variance analysis, and forecasting; ensure cost controls and value realization.
• Mentor, coach, and develop project managers and technical leads; establish clear performance expectations and career development plans.
• Lead risk management and contingency planning, including cybersecurity risk assessments and business continuity considerations for critical systems.
• Drive continuous improvement in project delivery, including lessons learned, metrics, and process optimization tied to compliance and quality outcomes.
• Facilitate regulatory readiness activities and audit support, prepare project artifacts for inspections, and ensure traceability of requirements, design, testing, and release records.

Benefits

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

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 5,001-10,000 employees