Enliven Therapeutics is a clinical-stage biopharmaceutical company focused on the discovery and development of small molecule inhibitors to help people with cancer not only live longer, but live better. The Company aims to address existing and emerging unmet needs with a precision oncology approach that improves survival and enhances overall well-being. Its discovery process combines deep insights in clinically validated biological targets and differentiated chemistry with the goal of designing therapies for unmet needs.
We are seeking a dynamic Manager/Senior Manager to join our growing Clinical Supply Chain team. We want someone who cares about this important work, and who’s driven to connect to our mission of helping these patient communities. The role will be responsible for end-to-end drug supply management activities related to forecasting, planning, label development, packaging & labeling operations, and IMP distribution for clinical trials globally. Will represent Clinical Supply Chain both internally with cross functional colleagues and externally with our CMO / CRO partner organizations.
What you will do:
- Drive clinical supply activities for both on-going and new clinical trials. This includes demand forecasting, trial monitoring & resupply planning, label design, packaging vendor management activities, IRT set-up and distribution activities.
- Manage label development and production planning / operations with established CMO vendors.
- Partner & build relationships with Clinical Research Organizations (CRO’s) for effective utilization of drug supply materials.
- Work collaboratively with Clinical Operations, Quality Assurance, CMC and Regulatory Affairs to efficiently deliver clinical supplies as needed while ensuring compliance to all applicable laws and regulations.
- Support both Program and Protocol level leadership across all functional areas and levels of the organization.
- Develop risk mitigation plans to proactively identify any potential issues that may impact drug supply.
- Provide leadership in the development and implementation of continuous improvement initiatives to improve lead-times, accelerate speed to customer, and reduce supply chain risks.
- B.S in pharmaceutics, chemistry, biology, material science, chemical engineer or related disciplines.
- 4 to 8 years of hands-on clinical supply experience in the pharmaceutical industry.
- Excellent project management, organization, and communication skills.
- Experience working with CMOs, CROs, and managing global logistics.
- Experience developing IWRS requirements, and exposure to various IWRS systems is a plus.
- Ability to navigate and be successful in a fast-paced, highly matrixed work environment
- Experience with clinical label design & execution.
- A desire to be part of a highly innovative company with the focus on helping patients.
- Opportunity for travel (10-15%)
Work Location: MA based/remote
Remote employees work entirely from home except for attending Company sponsored events/ meetings. For employees who choose to work remotely, travel may be required for certain company events commensurate to the above job description.
The expected salary range for this position is $120,000 - $155,000. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance.
Enliven Therapeutics is proud to be an equal opportunity employer. All employment offers are contingent upon the applicant successfully completing a background screen.
The statements contained herein are intended to describe the general nature and level of work to be performed. The statements are not to be construed as a complete and/or definitive list of the responsibilities, duties, and skills required of the employee. Furthermore, they do not imply a contract for employment and are subject to change with or without notice at the discretion of the employer.