Senior Director – PDM Product Strategy Leader

Senior Director – PDM Product Strategy Leader

Requirements

• A degree in science, engineering, or technical field with directly relevant professional experience of at least 14 years with a BA/BS or 12 years with an MA/MS, PhD, PharmD, or MD.
• Demonstration of outcome-oriented team leadership in some aspects of pharmaceutical manufacturing, or supply chain, or quality, or CMC regulatory, or process development, or as part of a cross-functional product team in the broader pharmaceutical industry.

Responsibilities

• Lead strategic cross-functional teams responsible for all technical and CMC aspects of assigned products.
• Translate business strategy and PST vision into the PDM plan for execution.
• Direct Process Development and Analytical Development teams to ensure effective and timely progression of pipeline projects and CMC life-cycle planning.
• Develop and own the product technical plan including timelines, multi-year budgets and critical deliverables.
• Ensure end-to-end design, execution and risk mitigation activities across Process, Formulation and Analytical work packages from FIH through commercialization.
• Identify process, analytical development, and control system risks and develop mitigation plans.
• Prepare annual revisions to the technical strategic plans for the products.
• Accountable for clear and timely communication to senior leadership on product activities throughout the enterprise against deliverables, timelines, and resources.
• Support other PDM Product Leaders in building a peer-group community with a range of technical backgrounds and experience through ongoing strategic coaching and skill development.
• Coach early in-career development scientists and engineers, and others working on the product team.

Preferred Qualifications

• Strong influencing skills to effectively lead in a highly matrixed environment with minimal positional authority within the enterprise product teams and across PDM.
• Cross-functional and enterprise-wide relationship building skills.
• A strong business process orientation but able to deploy processes practically and with the maximum impact.
• Knowledgeable in cGMP manufacturing and regulatory regulations and requirements for biologics and/or small molecules.
• Ability to work in a dynamic environment with multiple products and modalities.
• Strength in coaching and mentoring scientists and engineers across functional areas.
• Strong interpersonal, verbal, and written communication skills with the ability to synthesize complex situations, illustrate conceptual paths, and facilitate discussions leading to resolution on key issues.
• Ability to work efficiently and independently in a changing environment.
• Comfort with assuming responsibility and accountability for taking impactful decisions.
• Strong business and strategic skills – for example, converting the high-level goals for a product into a coherent plan for prioritized activities within PDM to support and deliver against those goals.