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Job Description

The Executive Director, Device Technical Operations is a pivotal leadership role within the Device Development & Technology (DD&T) organization in our Research Division. This position is responsible for providing strategic oversight, leadership for the technical transfer portfolio for medical devices and combination products, as well as combination product stewardship for inline products. The Executive Director will lead multiple functions in the department of approximately 50 employees, spanning multiple development projects and inline products across a range of delivery technologies.

This role is accountable for the portfolio of projects ensuring a successful scale-up/scale-out, commercialization, and transfer of medical devices and combination products into the manufacturing sites ensuring a robust supply. The role is accountable for ensuring each inline team has robust lifecycle-management plans, appropriate and rigorous technical support processes to support manufacturing sites, proactive risk management, performance monitoring, and continuous improvement. Experience with autoinjectors, prefilled syringes, and other drug delivery systems, or equivalent is required.

Key needs for this role include:

• Exceptional stakeholder management and partnering skills across multiple divisions, functions, and research and manufacturing sites.

• Building and hiring talent, developing team’s subject matter expertise, and strengthening leadership influence while fostering a culture of inclusion and rapid systematic learning.

• Clarifying and ensuring clear lines of ownership and accountability for the work with stakeholders and partners.

• Enhancing portfolio management and oversight to ensure strong program plans, identifying key risks, and ensuring proactive postures to create future robustness.

Primary Responsibilities:

Business Savviness and Executional Excellence:

• Develop and communicate a clear vision and ensure execution of the strategy for the technical transfer of medical devices and combination products, aligning with the overall business objectives for launch preparedness and enhanced robustness, regulatory, and compliance requirements of the company.

• Provide executive leadership and direction for the technical transfer portfolio, ensuring that programs are effectively managed, resourced, and aligned with organizational goals.

• Demonstrate enterprise leadership by fostering collaboration across multiple teams and departments, ensuring that all efforts are synchronized towards common objectives.

Program Portfolio Management:

• Oversee the portfolio of technical transfer and inline programs, ensuring that all initiatives are executed efficiently and meet quality standards, timelines, and budgetary requirements.

• Drive resource allocation, prioritization of projects, and operational excellence across technical transfer initiatives, working collaboratively with the Senior Director, Directors, and Associate Directors, and cross-functional teams.

• Utilize enterprise leadership principles and ways of working to optimize team performance and enhance project outcomes through effective delegation and empowerment.

• Drive resource allocation, prioritization of projects, and operational excellence across inline program support projects, working collaboratively with the Senior Director, Directors, Associate Directors, and cross-functional teams. Ensure in-line teams are appropriately monitoring the health of products and reacting to signals via data driven strategies.

Stakeholder Engagement and Communication:

• Foster strong relationships with key stakeholders, including research and development, manufacturing, quality assurance, regulatory affairs, and external partners, to ensure alignment and collaboration on product support and tech transfer.

• Communicate effectively with senior leadership, governance committees, and the executive team, providing regular updates on program status, risks, and opportunities for continuous improvement.

• Leverage enterprise leadership principles and ways of working to influence and engage stakeholders at all levels, ensuring their commitment to the technical transfer vision.

Risk Management, Compliance Oversight & Decision Making:

• Lead the establishment of a robust risk management framework for technical transfer and inline programs, proactively identifying, assessing, and mitigating potential risks to ensure patient safety and product quality.

• Ensure compliance with all regulatory requirements and quality standards, serving as a subject matter expert in the medical device and pharmaceutical industries. Partner with manufacturing sites for inspections, regulatory inquiries, complaints, and significant deviations.

• Apply enterprise leadership principles and ways of working to foster a culture of accountability and proactive risk management across all teams.

Innovation and Continuous Improvement:

• Champion a culture of innovation and continuous improvement within the technical transfer organization, encouraging teams to adopt best practices, leverage advanced technologies, and drive operational efficiencies.

• Stay abreast of industry trends, emerging technologies, and regulatory changes, adapting strategies and processes accordingly to maintain a competitive edge.

• Inspire teams to think creatively and embrace change, utilizing enterprise leadership principles and ways of working to guide them through transformation initiatives.

Team Leadership and Development:

• Lead, mentor, and develop the leadership team, including Senior Directors, Directors, and Associate Directors, to enhance their capabilities and drive high-performance teams.

• Promote a collaborative, inclusive, and high-performing work environment, empowering team members to excel and contribute to the organization’s success.

• Foster a culture of leadership development, ensuring that emerging leaders are equipped with the skills necessary to thrive in a dynamic environment.

Education:

• Advanced degree (Master's or PhD) in a relevant technical field (e.g., Engineering, Pharmaceutical Sciences, Biomedical Engineering).

Required Experience and Skills:

• Minimum of 20 years of progressive experience in medical device engineering, technical transfer, or related fields, with at least 10 years in senior leadership roles.

• Proven track record of successfully leading technical transfer and inline products/programs for medical devices and combination products, demonstrating a deep understanding of regulatory frameworks, quality management systems, and industry best practices.

• Exceptional strategic thinking, leadership, and communication skills, with the ability to influence, inspire, and drive change at the executive level and team level.

• Strong relationship management skills, with experience working effectively with cross-functional teams and external partners.

Location: West Point, PA or Rahway, NJ with travel up to 25%. Successful applicant would be expected to interact across all Pharmaceutical Sciences & Clinical Supply (PSCS) and our Research Division locations.

Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)

Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)

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 (https://survey.sogosurvey.com/r/aCdfqL) if you need an accommodation during the application or hiring process.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

EEOC Know Your Rights (https://www.eeoc.gov/sites/default/files/2022-10/22-088_EEOC_KnowYourRights_10_20.pdf)

EEOC GINA Supplement​

Pay Transparency Nondiscrimination (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp_%20English_formattedESQA508c.pdf)

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas 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 (https://www.msdprivacy.com/us/en/CCPA-notice/)

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 Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate’s relevant skills, experience, and education.

Expected US salary range:

$250,800.00 - $394,800.00

Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here (https://www.benefitsatmerck.com/) .

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:

Domestic

VISA Sponsorship:

Yes

Travel Requirements:

25%

Flexible Work Arrangements:

Not Applicable

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

N/A

Job Posting End Date:

03/31/2025

*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: R341814