Development Commercialization Leader

Job Description

The Development and Commercial Team leader (DCT) is accountable to Development Commercialization Review Committee (DCRC) for delivering a fully-integrated stage-appropriate development and commercialization strategy which yields the target commercial product.

Leads DCT. Critically assesses all team deliverables & fosters 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 including – 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.

Responsible to ensure the best science and most robust processes are used, working closely with DCRC. As the Product TPL takes ownership for the products’ technical processes and associated technical challenges, proactively prioritizing, interrogating and mitigating risks across technical, regulatory and operational factors. Conducts options analysis and provides recommendation to governance for endorsement.

Represents CMC and effectively communicates across the governance bodies, stakeholders and team. Drives outcomes/decisions through influence, advocacy, & negotiation with stakeholders. 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. Direct the necessary technical reviews, and ensure robust solutions and approaches are developed by working teams supporting the product.

Required to comply with our company's Global and regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day to day activities and all applicable job functions.

Work collaboratively to drive a safe and compliant culture in GSEC and within the teams that they interact with.

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 relationships with team members and key stakeholders to promote collaboration and seek robust perspectives.
• Drives Results through Accountability: Demonstrates effective leadership of team activities to ensure on-time, end-to-end project execution and delivery. Drives accountability within teams to follow through on commitments, provides direct feedback when individuals are not meeting expectations, and closely partners with senior leaders to deliver on priorities.
• Influence: Ability to persuade and inspire others to take action, make decisions, or change their attitudes and behaviors. Rapidly able to achieve trust with partners, enabling ability to navigate complex organizational dynamics to achieve their goals.
• Ownership: Exhibits a proactive mindset, a strong sense of initiative, and the willingness to take on challenges and see them through to completion. Fostering a culture of accountability and resiliency within the team or organization and empowering others to take ownership of their roles and responsibilities.

Educational Background and Experience:

• B.S. /M.S. /Ph.D. in one of the relevant Engineering or Science fields.
• Minimum of 15 years’ experience in biopharmaceutical or vaccine manufacturing and/or development, preferably a majority spent in science and technical role. Multiple years of experience as a leader with product development and new product introduction is required. Demonstrated expertise in technical aspects and interdependencies across DS, DP, device and analytical, regulatory, quality, and supply chain from early development through to commercial manufacturing. Demonstrated understanding of connectivity between clinical, CMC, and Human Health (Commercial Organization) to successfully launch a new product. Ability to navigate through uncertainty to favorable outcomes. Ability to challenge and influence clinical strategies; effectively communicating CMC perspectives and ensuring enrollment and alignment with clinical development teams (PDT). Able to operate and provide direction through ambiguity and adapt plans in the face of change, unexpected events, or new information.
• Demonstrated deep functional and enterprise leadership, ability to influence at all levels of the organization, holding team to high standards. Provides direct feedback when individuals/governance not meeting expectations. Drives accountability on team to follow through on commitments, leading to progression of program through milestones according to Governance (DCRC, DTRC, LDRC) expectations. Holds functions accountable to deliver. Creates and leads a high performing team, develops team members by working closely with functional leaders.
• Demonstrated excellent ability to develop creative and innovative solutions to complex problems, leveraging scientific expertise and growth mindset; fosters environment where DCT members can do the same. Approaches problem solving and project progression logically and in alignment with overall business needs.
• Effective communicator with demonstrated ability to tailor communications to diverse audiences, including governance, senior leadership, team members, stakeholders, and individuals with business and technical backgrounds. Active listening skills to understand others' perspectives, concerns, and ideas.
• Strategic outlook: Sees the big picture, thinks strategically, and demonstrates a customer orientation – both to the patient and to the long-term recipient of our new product process, methods, supply chain. Strong collaborative and talent-building skills and the ability to work strategically and in a detail-oriented framework with all levels of management.
• Teamwork: Ability to build and strong relationships with team members, key functional and site and divisional leaders, and XDT members to promote effective collaboration. Ensures a strong team environment for open discussions, enabling all team members to contribute their perspectives and collectively resolve issues.

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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”.

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Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

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Requisition ID:R326535