Senior Director, Stability Operations and Device Program Management

MSD•Upper Gwynedd Township, PA

2d•$173,200 - $272,600•Hybrid

About The Position

Pharmaceutical Analysis and Digital Technologies (PADT) is seeking an exceptional scientific and operational leader for the role of Senior Director, Stability Operations and Device Program Management. This position will provide strategic ownership and end-to-end leadership for stability operations across the development portfolio through commercialization, while also leading device program management activities that enable integrated delivery of drug-device combination products and associated analytical, technical, and regulatory deliverables. The successful candidate will lead a team of scientists, operational experts, and program management professionals responsible for building and executing a robust, compliant, and scalable stability operations model. The role will require strong people leadership, cross-functional influence, portfolio-level prioritization, and the ability to translate complex development needs into clear operational plans that support product quality, regulatory submissions, clinical supply, and lifecycle management. The scope of this position includes strategic oversight of stability study design, protocol execution, sample management, stability data governance, operational readiness, and inspection preparedness for development programs across modalities. In addition, the Senior Director will partner with device development, CMC, regulatory, clinical, quality, manufacturing, and external partners to ensure device program plans are integrated with product development strategies, key milestones are delivered, and risks are proactively managed. The Senior Director will oversee the technical writing and change control team, ensuring timely delivery of BLA authoring, global change controls, and technical documentation. The role will set documentation standards, manage portfolio priorities, and partner with the digital team to support digital CMC and modernize the commercial filing strategy. These activities will support regulatory submissions, inspection readiness, and efficient execution of product and process changes.

Requirements

Ph.D. degree in Chemistry, Pharmaceutical Sciences, Engineering, Biology, Biochemistry, or related scientific discipline with 10+ years of relevant experience.
MS degree with 13+ years of relevant experience.
BS degree with 16+ years of relevant experience.
Demonstrated ability to lead large, inclusive, cross-functional scientific or operational teams and to attract, develop, and retain talent.
Extensive experience in pharmaceutical development, stability operations, analytical development, CMC, quality, regulatory, or related technical disciplines.
Strong working knowledge of stability requirements, GxP expectations, regulatory guidance, product quality principles, and inspection readiness practices.
Experience leading complex programs, managing portfolio-level priorities, and influencing senior stakeholders across functions and geographies.
Ability to integrate scientific, technical, operational, regulatory, and business considerations into clear program strategies and executable plans.
Excellent verbal and written communication skills, with the ability to present complex information clearly to technical teams, governance forums, and senior leaders.

Nice To Haves

Proven track record leading stability operations, analytical operations, device development, combination product programs, or cross-functional CMC program management in a regulated pharmaceutical environment.
Experience developing operating models, governance processes, metrics, and continuous improvement initiatives that improve delivery, compliance, and portfolio transparency.
Experience supporting regulatory submissions, health authority interactions, inspections, or product lifecycle activities related to stability, analytical, device, or combination product deliverables.

Responsibilities

Provide strategic, scientific, operational, and people leadership for stability operations and device program management across the development portfolio.
Establish and maintain an integrated operating model for stability study planning, protocol execution, sample logistics, storage, testing coordination, data review, and reporting.
Lead device program management activities to ensure clear plans, governance, risk management, decision making, and milestone delivery for drug-device and combination product programs.
Partner with cross-functional development teams, including CMC, regulatory, clinical, quality, manufacturing, supply chain, device development, and external partners, to align stability and device deliverables with program objectives.
Ensure stability operations and device program management practices are inspection ready, compliant with applicable GxP expectations, and aligned with internal quality systems and regulatory commitments.
Develop and implement portfolio-level metrics, dashboards, and governance routines to monitor delivery, identify risks, drive continuous improvement, and support transparent communication with senior stakeholders.
Build, mentor, and develop a high-performing, inclusive team with the scientific, operational, and program management capabilities required to support a complex and evolving development portfolio.