Senior Director, CMC Project Management, Bioconjugate Modalities

About the role

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.

Responsibilities

• 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 efficiency 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.
• Mentor 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.

Requirements

• BS/BA degree in a scientific or engineering discipline with 10+ years of industry drug development/commercialization experience OR 5+ years of industry drug development experience with an advanced degree.
• Experience leading CMC development across the multi-component bioconjugate supply chain — including antibody intermediate, linker-payload, conjugation, and drug product — to align timelines, quality, and deliverables across internal teams and external partners.
• Succinct communicator with proficiency in English (written and spoken).
• Strong leadership, communication, risk management, and decision-making skills.
• Willing to relocate to Indianapolis, Indiana.

Qualifications

• Advanced degree strongly preferred (MS, MBA, PhD or PharmD).
• Demonstrated deep technical knowledge and experience of bioconjugate modality drug development, commercialization and manufacturing processes, including antibody drug conjugates (ADCs), antibody peptide conjugates (APCs), antibody RNA conjugates (ARCs), and/or peptide RNA conjugates (PRCs).
• Practical experience (formal or informal) in project management of cross-functional projects.
• Able to lead cross-functional team(s) and together solve complex problems.
• Able to rapidly become proficient in new tools.
• Demonstrated ability to communicate complex issues timely, accurately, and succinctly.

Skills

• Strategic thinking and project management skills.
• Technical expertise in CMC development and bioconjugate drug modalities.
• Excellent communication and interpersonal skills.
• Ability to manage multiple priorities and deadlines.
• Knowledge of regulatory requirements and compliance.

Benefits

• Comprehensive benefit program including 401(k), pension, vacation benefits, medical, dental, vision, and prescription drug benefits, flexible benefits, life insurance, death benefits, time off and leave of absence benefits, and well-being benefits.

Pay

$156,000 - $228,800

Schedule

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).