Sr. Director - CMC Project Management, Biologic Modalities

Lilly • Indianapolis, IN

10h • $156,000 - $253,000 • Onsite

About The Position

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.
Organization Overview:
At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.
Position Summary:
The Senior Director, CMC Project Management will provide strategic and operational leadership for cross-functional CMC team(s) and will partner with CMC scientific and technical leaders with accountability for technical deliverables. CMC Project Management is the program and project management arm of our critical Product Research and Development group. CMC Project Managers are responsible for leading the creation, development, communication, and implementation of integrated CMC plans for assets from portfolio entry to global submissions/approvals and launch.

Requirements

• BS/BA degree in a scientific or engineering discipline
• Minimum of 10+ years of industry biologic modality drug development/commercialization experience with BS/BA degree or minimum of 5 years of industry biologic molecule drug development experience with an advanced degree
• Demonstrated deep technical knowledge and experience of biologic modality drug development, commercialization and manufacturing processes, including biologics modalities modalities (monoclonal antibodies) and advanced Gene & Cell therapeutics (adeno-associated virus, mRNA-LNP, CAR-T, allogeneic and autologous cell therapies)

Nice To Haves

• Advanced degree strongly preferred (MS, MBA, PhD or PharmD)
• Practical experience (formal or informal) in project management of cross-functional projects
• Demonstrated ability to lead cross-functional team(s) and together solve complex problems
• Demonstrated ability to rapidly become proficient in new tools
• Demonstrated ability to communicate complex issues timely, accurately, and succinctly
• This role requires relocation and on-site presence at the Indianapolis facilities
• Experience with early and late-stage product development including knowledge of the global regulatory submission/approval process for biologic modalities, including conventional biologics and advanced Gene & Cell therapeutics
• Must be succinct communicator with fluency in English (written and spoken)
• Must have demonstrated strong leadership, communication, risk management, and decision making skills

Responsibilities

• Effectively partner with global program teams and therapeutic areas to translate clinical, asset and portfolio strategy into clear CMC development and delivery goals for cross-functional CMC teams.
• Lead the creation, development, communication, and implementation of integrated CMC plans for assets with the functional CMC areas from portfolio entry through global submissions, approvals, and launch.
• Leverage portfolio knowledge, development, and financial acumen to enable investment strategy and optimization at both project and portfolio level.
• Drive cross-functional CMC teams to maximize the value of data, create bold, competitive plans, anticipate risks, effectively communicate risks, enable high quality decisions at fast speed and implement decisions.
• Understand when and how to appropriately raise issues to teams and to stakeholders. Keep both team members and stakeholders fully apprised of project status and issues at the right level of detail.
• Develop high performing matrix teams with an ability to quickly identify gaps in team effectiveness and implement remediation efforts to ensure project success.
• Support Due Diligence efforts by leading CMC development plans while integrating and communicating key findings with stakeholders.
• Coach new PMs in the management of a development project: team dynamics, understanding stages of development and how functional inputs interact to ensure project progression, processes relating to CMC development, strategic document preparation, and PM best practices.
• Participate in or lead continuous improvement projects, which significantly impact the work and/or effectiveness of CMC development.

Benefits

• Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).
• Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).

What This Job Offers

• Job Type: Full-time
• Career Level: Director