Director, Lead of Strategy for Device Product Assessment & Innovation

Job Description

Position Overview

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 preferred

• Advanced scientific degree (e.g., MS, PharmD, Ph.D.) preferred

• Project Management certification / training (PMP) and / or coursework & training in Project Management preferred

Experience

• Minimum of 10 years of experience in pharmaceutical/medical device industry with at least 5 years in project or program management roles

• Demonstrated experience in leading organizational transformation initiatives and driving strategic change

• Experience with drug-device combination product development, regulatory requirements, and commercialization strongly preferred

• Track record of successfully managing complex, cross-functional projects and initiatives

• Experience in building and leading high-performing teams

Skills and Competencies

• Strategic thinking and independent decision-making abilities with excellent business acumen

• Demonstrated ability to develop strong, trust-based collaborative relationships to drive change and execute priorities with diverse stakeholders

• Exceptional communication skills with the ability to communicate clearly, effectively, and tactfully at all organizational levels

• Strong understanding of GMP and regulatory requirements for drug-device combination products

• Proven a