Executive Director, Device Product Platforms

MSD • Upper Gwynedd Township, PA

1d • Hybrid

About The Position

The Executive Director, Device Product Platforms (DPP) will serve as a strategic and operational leader, responsible for shaping and executing the organization’s vision for Drug Device Combination Products. This role emphasizes a platform-based approach, ensuring seamless, cross-functional product delivery that aligns with the evolving needs of the Research and Development (R&D) pipeline. The Executive Director will drive scientific and technical excellence, foster innovation, and develop high-performing teams to achieve optimal efficiency in device development, design, and commercialization. The Executive Director, Device Product Platforms, Device Development & Technology reports to the Associate Vice President, Device Development & Technology. The Device Development and Technology (DD&T) organization resides within the Pharmaceutical Sciences and Device Development (PSDD) organization of our R&D Division and collaborates closely with other functional and therapeutic area leaders.

Requirements

• Advanced degree (Ph.D. or M.S. preferred) in Mechanical Engineering, Biomedical Engineering, or Materials Engineering.
• Minimum 15 years of progressive engineering leadership experience in device or combination product development within the pharmaceutical, biotechnology, or medical device industry.
• Demonstrated experience with device and combination products in at least three of the following therapeutic areas (preferably with marketed products): Cardiometabolic, Infectious Disease, Ophthalmology, Immunology, Oncology, Neuroscience.
• Proven track record in at least five of the following device categories (preferably with marketed products): Prefilled Syringes for vaccines; Intravitreal Prefilled Syringes for eye injections; Prefilled Syringe needle safety devices; 1 mL Auto Injectors; 2 mL Auto Injectors; >2.25 mL Auto Injectors; Pen Injectors; Combination Product Kits; Dry Powdered Inhalers; other Nasal Delivery mechanisms.
• Proven ability to drive platform-based product development strategies.
• Strong ability to lead scientific and technical teams, drive organizational change, and influence at all levels of the organization.
• Takes proactive steps to strategically shape the future of the organization.
• Provides timely feedback and coaching to talent across the new product development and commercialization business areas. Actively builds the best team and manages performance. Demonstrated commitment to fostering inclusion and belonging.
• Applies a deep understanding of new product development and commercialization business, inclusive of external landscape, to shape strategy. Demonstrates understanding of connectivity between clinical development, chemistry, manufacturing and control (CMC) and human health, balancing the needs of patients and ensuring successful launch and stable supply of product.
• Excellent cross-functional collaboration, stakeholder management, and communication skills. Actively engages in two-way communication to build trusting relationships. Experience leading organizations through transformation and growth.
• Drives operational excellence by clarifying and translating priorities into actionable steps.
• In-depth understanding of global regulatory requirements and quality standards for medical devices and combination products.
• Challenges teams to gather and compare information/data from multiple sources to influence program decisions with facts and data. Strong analytical, decision-making, and problem-solving skills.
• Accountability
• Business Development
• Combination Products
• Design Control Process
• Design for Six Sigma (DFSS)
• Device Development
• Human Factors
• Leadership
• Learning Quickly
• Management Engineering
• Manufacturing Processes
• Mechanical Engineering
• Neuroanatomy
• Neuroethics
• Neuroradiology
• Operation Risk Management
• Ophthalmology
• People Management
• Platform Design
• Regulatory Submissions
• Strategic Initiative
• Strategic Planning

Nice To Haves

• 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.
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• 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/International
• VISA Sponsorship: Yes
• Valid Driving License: No
• Hazardous Material(s): N/A

Responsibilities

• Lead and inspire the Device Product Platforms (DPP) organization, including driving Platform Leadership for Auto Injectors (for multiple therapeutic areas), Prefilled Syringes for Vaccines, Prefilled Syringes for Intravitreal Injections, Combination Product Kits, and Inhalation Devices; as well as providing Functional Leadership for Device Design & Process Development.
• Develop and implement strategic initiatives to advance a platform-based approach to deliver the portfolio that is device and combination products enabled, ensuring integration across internal and external functional teams and alignment with DD&T and enterprise objectives.
• Retain and develop top technical talent, promote skills and expertise, and foster a culture of scientific and technical excellence.
• Provide expert guidance on the design, development, and evaluation of device products, components, materials, packaging systems, and manufacturing processes.
• Oversee verification strategies, material properties assessments, design assessments; leverage data analysis and risk-based approaches aligned with best-in-class combination product development and commercialization.
• Drive innovation and continuous improvement in product quality and process efficiency.
• Oversee the Drug Device Combination Products portfolio across all therapeutic areas, modalities, and platforms for our company's molecule portfolio that is device and combination products enabled.
• Ensure robust platform expertise in prefilled syringes for vaccines (1 mL, 2.25 mL, 5.5 mL), auto injectors, pen injectors, combination product kits, prefilled syringes for intravitreal injections, inhalation devices, and other nasal delivery mechanisms.
• Support the evolution of the organization by identifying and developing future platform leaders as the pipeline needs evolve.
• Collaborate with stakeholders across Research, Clinical, Regulatory, Quality, and Manufacturing to ensure seamless product development and commercialization.
• Strategically represent the DPP organization in global forums, cross-divisional governance forums, cross-functional teams, and with external partners as needed.
• Ensure compliance with regulatory requirements and industry standards for combination products and medical devices.
• Identify and mitigate technical and operational risks across the product lifecycle working with cross-functional teams across the enterprise.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Executive
• Education Level: Ph.D. or professional degree