Director, Clinical Program Management
Bristol-Myers SquibbSalary not specified
Full Time
Expert & Leadership (9+ years)
Associate Director - CMC Development at Eli Lilly and Company
Philadelphia, Pennsylvania, United States
Not SpecifiedCompensation
Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level
Full TimeJob Type
UnknownVisa
Pharmaceuticals, Healthcare, BiotechnologyIndustries
Requirements
- Experienced in CMC development and manufacturing programs for radiopharmaceuticals
- Strong leadership skills to lead cross-functional matrix teams (Process Development, Analytical Sciences, Manufacturing, Quality, Supply Chain, R&D, Finance, Regulatory)
- Expertise in developing strategic technical plans and operational leadership
- Superior organizational skills, proactive self-starter with strong executive presence
- Passion for driving operational excellence in CMC Development
- Ability to serve as primary point of contact, cross-functional subject matter expert, and thought leader
- Availability for hybrid position requiring minimum three days per week on-site at Philadelphia office
Responsibilities
- Serve as the CMC Lead for one or more development assets, ensuring integrated planning, execution, and governance across internal and external functions
- Build and lead fit-for-purpose cross-functional CMC matrix teams, aligning timelines, deliverables, and risk mitigation strategies to ensure critical development milestones are met
- Identify, evaluate, monitor, manage, and communicate risks and associated mitigation plans; ensure timely communication with senior management and across relevant functional areas
- Support regulatory strategy development and health authority interactions related to CMC
- Drive development and execution of CMC activities in support of IND, CTA, and BNDA/MAA submissions
- Develop, maintain, and enforce integrated program timelines, assign and ensure completion of action items, lead CMC team meetings
- Identify and manage risk, partner closely with broader program stakeholders and leadership to align program activities with business goals
Skills
CMC Development
Radiopharmaceuticals
Manufacturing
Pharmaceutical Development
Drug Manufacturing
Therapeutics
Diagnostics
Eli Lilly and Company
Develops and delivers prescription medicines globally
About Eli Lilly and Company
Eli Lilly and Company is a global pharmaceutical company that focuses on discovering, developing, and delivering medicines to improve health. The company has a long history of scientific achievements, including the creation of insulin, the first life-saving treatment for diabetes. Lilly's operations involve extensive research and development to create new medications and enhance existing ones, ensuring they are safe and effective. Their products are primarily prescription medicines sold to healthcare providers for various medical conditions, including diabetes, cancer, and pain management. What sets Lilly apart from its competitors is its strong commitment to ethical practices and the protection of its products from counterfeiting. The company's goal is to enhance lives through innovative medical solutions while maintaining high standards of quality and ethics.
Indianapolis, IndianaHeadquarters
1876Year Founded
$1,180.1MTotal Funding
IPOCompany Stage
Biotechnology, HealthcareIndustries
10,001+Employees