Director, Lead Of Strategy For Device Product Assessment & Innovation
At our Company, we are enhancing our investment in device development and commercialization capabilities to support our growing pipeline of drug-device combination products. Our integrated team is responsible for the entire spectrum of activities from innovation, development, commercialization, as well as product lifecycle management for drug-device combination products. Reporting to the Sr. Director of Device Product Assessment & Innovation (DPAI), the Director, Lead of Strategy for Device Product Assessment & Innovation will define and build strategic roadmaps to manage governance, operations, and cross-functional processes that drive efficient, discovery facing innovations and decision-making strategy for all elements of early development. They will lead various early development and innovation initiatives to support continuous improvement that translates DPAI strategy and objectives to execution.
Key Responsibilities
Strategic Leadership, Business Acumen & Innovation
- Define strategic priorities and roadmaps aligned with portfolio and business objectives.
- Build the framework for, and operationalize, a Device Target Product Profile (DTPP) with insights from the Target Candidate Profile (TCP) and Target Product Profile (TPP) to define clear device requirements aligned with commercial and clinical goals.
- Construct overall development strategies, timelines, and transition plans into fully commissioned Device Development Working Groups, including resource planning projections.
- Monitor industry trends, state of the art, and emerging technologies to inform and evolve strategic direction.
Stakeholder Engagement, Partnerships & Influence
Identify key stakeholders / opinion leaders across our company to establish network mapping.Drive engagement sessions to identify gaps and challenges in the device innovation space; lead efforts to co-develop solutions.Advocate for early consideration of device usability, human factors, and differentiated product attributes, leveraging knowledge of competitive and commercial landscapes and through work with the broader DPAI team.Establish means to engage with development and in-line product support teams to identify lifecycle management opportunities for assets currently in development and / or marketed.Develop and execute communication plans that ensure stakeholder alignment and foster commitment across divisional / departmental stakeholders.Decision Making & Continuous Improvement
Develop and implement governance structures and operating models for early device development and innovation.Integrate elements of local governance into the border our Company governance structures (ex. DCRC, LDRC, CMC-wide).Establish key performance indicators (KPIs) to measure progress towards organizational goals and drive performance excellence.Drive continuous improvement across processes and decision-making frameworks that include end to end (from early discovery to lifecycle management).Required Qualifications
Education
Bachelor's degree required with a concentration in a scientific-related discipline strongly preferredAdvanced scientific degree (e.g., MS, PharmD, Ph.D.) preferredProject Management certification / training (PMP) and / or coursework & training in Project Management preferredExperience
Minimum of 10 years of experience in pharmaceutical / medical device industry with at least 5 years in project or program management rolesDemonstrated experience in leading organizational transformation initiatives and driving strategic changeExperience with drug-device combination product development, regulatory requirements, and commercialization strongly preferredTrack record of successfully managing complex, cross-functional projects and initiativesExperience in building and leading high-performing teamsSkills and Competencies
Strategic thinking and independent decision-making abilities with excellent business acumenDemonstrated ability to develop strong, trust-based collaborative relationships to drive change and execute priorities with diverse stakeholdersExceptional communication skills with the ability to communicate clearly, effectively, and tactfully at all organizational levelsStrong understanding of GMP and regulatory requirements for drug-device combination productsProven ability to identify risks to project timelines, scope, or deliverables and escalate appropriatelyExperience in designing governance processes that provide executive visibility and decision supportDemonstrated situational leadership in high-ambiguity settings and creative problem-solvingEffective at energizing others, establishing clear goals, delegation, mentoring, and coachingStrong facilitation skills for leading cross-functional meetings and workshopsRequired Skills : International Product Development, Leadership, Leadership Training and Development, Management Process, Medical Devices, Medical Product Development, People Management, Product Demonstrations, Product Development Consulting, Product Development Design, Product Development Quality, Safety Needles, Team Management
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".
Salary Range : $153,800.00 - $242,200.00
The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits.