Dir, Engineering, Small Molecule Development and Commercialization Team Leader

Job Description

The Director, DCT Leadership position in our company's Manufacturing Division is a dedicated full-time role and is accountable for leading the DCT at Line of Sight to Commercial Product Definition.  This pivotal role encompasses both technical and strategic responsibilities, as it entails guiding drug product candidates from development to launch in line with enterprise priorities. 

As the DCT leader, the Technical Product Leader (TPL) in our Manufacturing Division is:

• Accountable to the Development Commercialization Review Committee (DCRC) for delivering a fully integrated stage-appropriate development and commercialization strategy which yields the target commercial product. 
• Leads the cross-functional DCT, critically assessing all team deliverables & fostering a learning and collaborative environment.  Prioritizes, interrogates, and mitigates risks across all factors that may impact technical, operational & regulatory success or timelines.  Analyzes and develops innovative solutions to unforeseen circumstances.
• Responsible for end-to-end technical product leadership (TPL) and oversight of the on-time execution of DCT deliverables inclusive of robust processes & analytics, an integrated control strategy, successful tech transfer packages, filing and approval, and a robust commercial supply chain to achieve launch on time and uninterrupted long-term supply.
• Represents CMC and effectively communicates across the governance bodies, stakeholders, and team to drive outcomes/decisions through influence, advocacy, & negotiation with an enterprise mindset.  As the CMC representative, influences and challenges the xDT strategy to ensure a robust CMC strategy is achieved.  Identifies options to balance Speed/Cost/Robustness & achieve target commercial product.  

Core Competencies Required for the Role:

• Development and Commercialization Experience:  Demonstrated expertise of technical aspects and interdependencies across DS, DP, Device, Packaging, and Analytical, Regulatory, Quality, and Supply Chain from early development through to commercial manufacturing.  Deep understanding of connectivity between clinical, CMC, and HH to successfully launch a new product.
• Technical Depth and Breadth of Experience:  Recognized as a credible technical leader through demonstrated scientific excellence in at least one CMC function and ability to navigate through uncertainty to favorable outcomes.
• Strategic Thinking/Enterprise Mindset:  Understands and can articulate the “Big” picture, thinks strategically, and demonstrates a customer orientation.  Demonstrated ability to know how to ask the right questions to drive critical conversations to the best decision for the enterprise, considering options which balance speed, cost, and robustness.  Challenges team members to think beyond their area of expertise for the broader interests of the company and patients we serve.
• Problem Solving and Innovative Thinking:  Gathers and analyzes data and effectively responds to new or complex situations, developing creative and innovative solutions to solve and mitigate complex problems.  Ability to leverage scientific expertise and growth mindset to interrogate data and foster debate within teams to enable innovative and robust problem solving. 
• Ability to Navigate Ambiguity:  Able to operate and provide direction through ambiguity and adapt plans in the face of change, unexpected events, and/or new information.  Capable of both directive and consensus facilitation and awareness of when to apply each.  Leverages scientific data to make disciplined risk-based decisions and shown to be capable of discerning between risks worthy of escalation versus typical uncertainty associated with drug development, commercialization, and/or supply.
• Productive Communication:  Plans and delivers ideas and information to others in an impactful manner with proven ability to lead complex discussions, influence stakeholders, and drive outcomes in the best interest of the enterprise.  Capable of tailoring communications to diverse audiences, including governance bodies, senior leadership, team members, and individuals with diverse backgrounds.  Practitioner of active listening who consistently strives to understands others’ perspectives, concerns, and ideas.
• Collaboration and Teamwork:  Creates, leads, and sustains high performing teams, fostering an environment of open communication, enabling all team members to contribute their perspectives and collectively resolve issues.  Actively builds strong relationshi