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Senior Director, CMC Project Management
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BioSpace . 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 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 put people first and are looking for individuals determined to make life better for people around the world. 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. We deliver breakthrough medications and support communities through philanthropy and volunteerism. Position Summary
The Senior Director, CMC Project Management will provide strategic and operational leadership for cross-functional CMC teams and partner with CMC scientific and technical leaders, accountable for technical deliverables. CMC Project Management is the program and project management arm of our Product Research and Development group. CMC Project Managers lead the creation, development, communication, and implementation of integrated CMC plans for assets from portfolio entry to global submissions/approvals and launch. 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. Basic Requirements
BS/BA degree, preferably in a scientific or engineering discipline 10+ years of drug development or combination product experience Must be succinct communicator with fluency in English (written and spoken) Additional Preferences
Advanced degree strongly preferred (MS, MBA, PhD or PharmD) Understanding of development phases, associated CMC deliverables, and interactions of various functional areas and how each relates to a comprehensive strategy Global submissions/approvals experience Supervisory experience 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 Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form for further assistance. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Learn more about all of our groups. Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $151,500 - $222,200. Full-time employees will be eligible for a company bonus and a comprehensive benefits program including 401(k); pension; vacation benefits; medical, dental, vision and prescription drug benefits; flexible benefits; life insurance; time off and leave; and well-being benefits. Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion. #WeAreLilly Seniority level
Director Employment type
Full-time Job function
Project Management and Information Technology Industries
Internet News
#J-18808-Ljbffr
Join to apply for the
Senior Director, CMC Project Management
role at
BioSpace . 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 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 put people first and are looking for individuals determined to make life better for people around the world. 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. We deliver breakthrough medications and support communities through philanthropy and volunteerism. Position Summary
The Senior Director, CMC Project Management will provide strategic and operational leadership for cross-functional CMC teams and partner with CMC scientific and technical leaders, accountable for technical deliverables. CMC Project Management is the program and project management arm of our Product Research and Development group. CMC Project Managers lead the creation, development, communication, and implementation of integrated CMC plans for assets from portfolio entry to global submissions/approvals and launch. 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. Basic Requirements
BS/BA degree, preferably in a scientific or engineering discipline 10+ years of drug development or combination product experience Must be succinct communicator with fluency in English (written and spoken) Additional Preferences
Advanced degree strongly preferred (MS, MBA, PhD or PharmD) Understanding of development phases, associated CMC deliverables, and interactions of various functional areas and how each relates to a comprehensive strategy Global submissions/approvals experience Supervisory experience 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 Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form for further assistance. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Learn more about all of our groups. Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $151,500 - $222,200. Full-time employees will be eligible for a company bonus and a comprehensive benefits program including 401(k); pension; vacation benefits; medical, dental, vision and prescription drug benefits; flexible benefits; life insurance; time off and leave; and well-being benefits. Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion. #WeAreLilly Seniority level
Director Employment type
Full-time Job function
Project Management and Information Technology Industries
Internet News
#J-18808-Ljbffr