Executive Director, Device Technical Operations
Executive Director, Device Technical Operations
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$ 250800 - 394800
1 Vacancy
Job Description
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 scaleup/scaleout commercialization and transfer of medical devices and combination products into the manufacturing sites ensuring a robust role is accountable for ensuring each inline team has robust lifecyclemanagement plans appropriate and rigorous technical support processes to support manufacturing sites proactive risk management performance monitoring and continuous 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 teams 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 crossfunctional 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 crossfunctional teams. Ensure inline 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 highperformance teams.
Promote a collaborative inclusive and highperforming work environment empowering team members to excel and contribute to the organizations success.
Foster a culture of leadership development ensuring that emerging leaders are equipped with the skills necessary to thrive in a dynamic environment.
Education:
BS degree or higher in a relevant technical field (e.g. Engineering Pharmaceutical Sciences Biomedical Engineering)
Advanced degree (Masters or PhD) preferred
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 crossfunctional 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
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 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 anothers thinking and approach problems collectively.
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U.S. Hybrid Work Model
Effective September 5 2023 employees in officebased positions in the U.S. will be working a Hybrid work consisting of three total days onsite per week Monday Thursday although the specific days may vary by site or organization with Friday designated as a remoteworking day unless business critical tasks require an onsite Hybrid work model does not apply to and daily inperson attendance is required for fieldbased positions; facilitybased manufacturingbased or researchbased positions where the work to be performed is located at a Company site; positions covered by a collectivebargaining 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 candidates relevant skills experience and education.
Expected US salary range:
$250800.00 $394800.00Available 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.
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 preexisting agreement is in place. Where agency agreements are in place introductions are position specific. Please no phone calls or emails.
Employee Status:
RegularRelocation:
DomesticVISA Sponsorship:
YesTravel Requirements:
25%Flexible Work Arrangements:
Not ApplicableShift:
Not IndicatedValid Driving License:
NoHazardous Material(s):
N/AJob Posting End Date:
05/12/2025*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Required Experience:
Director
Employment Type
Full-Time
