Sr. Manager, Clinical Supplies Project Manager

Initial Therapeutics, Inc.; Cambridge (MA); On-site; USD 131,000 - 209,000; Full time

Benefits offered by this job

Competitive healthcare

Bonus potential

Paid time off

Equity eligibility

Job summary

Moderna is seeking a Sr. Manager, Clinical Supplies Project Management to lead clinical drug supply needs across projects and coordinate with packaging, labeling, IRT vendors, CROs and cross-functional teams.

The role requires attention to detail, collaboration, and the ability to manage workload to meet program timelines, with responsibility for planning, forecasting and KPI development across multiple trials.

Qualifications

• 5–8 years of clinical drug supply management experience in a clinical research environment.
• Bachelor’s degree in a science-based subject.
• Cold chain packaging, labeling, distribution experience.
• IRT design and management experience.
• Clinical Supplies Planning and Forecasting experience.
• Experience with Clinical Supply Inventory Management systems.
• Biopharmaceutical/pharma manufacturing experience preferred.

Responsibilities

• Logistics for labeling, packaging and shipment of clinical drug supplies to depots and sites.
• Participate in business review meetings with third party drug supply vendors.
• Responsible for IRT requirements, user acceptance testing, and management.
• Clinical Supplies Planning and Forecasting to meet program objectives.
• Develop and compile KPIs for performance tracking.
• Liaison for inventory control and distribution activities, including scheduling and vendor oversight.
• Work with CMC for Production Planning & Distribution and forecast drug supply needs.
• Ensure SOP compliance and implement industry best practices.
• Coordinate and schedule drug labeling and packaging with CMC and regulatory teams.
• Oversee vendor activities including procurement, labeling performance and on-time delivery.

Skills

Clinical supplies management

IRT design

Vendor management

Forecasting

CMC coordination

Regulatory awareness

Cross-functional teamwork

SOP compliance

Education

B.S. in Science

Tools

Inventory management systems

Job description

The Role:

Moderna is seeking a Sr. Manager, Clinical Supplies Project Management to manage the clinical supplies needs across its projects, as well as work with packaging and labeling and IRT vendors and CROs. This position works collaboratively across several therapeutic area teams as well as cross functionally to support study needs. This successful candidate will be skilled at understanding the needs of critical programs with attention to detail, with a collaborative outlook, and with the ability to manage workload and meet project timelines.

Here’s What You’ll Do:

• Responsible for logistics as required to support the labeling, packaging and shipment of clinical drug supplies to depots/investigative sites as well as other clinical supplies as necessary


• Participate in business review meetings with third party drug supply vendors


• Responsible for IRT requirements, user acceptance testing, and management


• Responsible for Clinical Supplies Planning and Forecasting as required to meet program objectives


• Develop and compile KPIs (metrics)


• Primary liaison for inventory control and distribution activities including scheduling, issue resolution, change implementation, vendor oversight and scope review related to clinical supplies


• Manages/Works with third party vendors, Functional Leads and interface with CMC for Production Planning & Distribution; develops forecast of all drug supply needs and works with CMC department to ensure goals are met


• Generates and reviews processes as required and ensures compliance to relevant SOPs


• Implements Industry Best Practices and templates for clinical drug supply activities


• Works with CMC and clinical group on Master Production Schedule so timing of clinical trial drug needs are met


• Maintains collaborative relationships with third party vendors to assure the complete scope of planning activities remains connected with operations and compliant with quality requirements


• Monitors and tracks shipments to ensure smooth transit through the logistical path –including international shipping


• Responsible for coordinating and scheduling drug labeling and packaging activities in conjunction with CMC, clinical, regulatory departments


• Oversee vendor activities including procurement, labeling performance, on-time delivery, quality, improvement initiatives and issue resolution


• Develop pharmacy manual in conjunction with relevant cross functional leads


• Develop drug supply training materials for investigational sites

Here’s What You’ll Bring to the Table:

• At least 5 -8 years of clinical drug supply management/clinical supply chain/clinical supplies experience in a clinical research environment is preferred


• Bachelor’s degree in a science-based subject


• Prior Cold Chain packaging, labeling, distribution experience required


• IRT design and management experience required.


• Clinical Supplies Planning and Forecasting experience required


• Experience with Clinical Supply Inventory Management systems required


• Prior Biopharmaceutical, pharmaceutical or chemical manufacturing experience preferred


• Creative, capable problem-solver


• Experience in establishing and maintaining relationships with vendors and attending business review meetings (Vendor oversight)


• Working knowledge of ICH, FDA, IRB/IEC and other applicable regulations/guidelines and demonstrated understanding of clinical research protocol requirements


• Demonstrated proficiency with word processing, spreadsheet, database, presentation software (MS Office skills such as Outlook, Word, Excel, PowerPoint, and SharePoint)


• Successful candidate will be curious in exploring new path for clinical research, bold in proposing creative solutions and ideas. Will work collaboratively with multifunctional teams and partners and will be relentless in pursuing successful outcomes

Pay & Benefits

At Moderna, we believe that when you feel your best, you can do your best work. That’s why our benefits and well-being resources are designed to support you—at work, at home, and everywhere in between.

• Competitive healthcare, plus voluntary benefit programs to support your unique needs


• A holistic approach to well-being, with access to fitness, mindfulness, and mental health support


• Family planning benefits, including fertility, adoption, and surrogacy support


• Generous paid time off, including vacation, volunteer days, sabbatical, global recharge days, and a discretionary year-end shutdown


• Savings and investments to help you plan for the future


• Location-specific perks and extras

The salary range for this role is $130,800.00 - $209,400.00. This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An individual’s position within the salary range will be based on several factors including, but not limited to, specific competencies, relevant education, qualifications, certifications, experience, skills, performance, and business or organizational needs.The successful candidate may be eligible for an annual discretionary bonus, other incentive compensation, or equity award, subject to company plan eligibility criteria and individual performance.

About Moderna

Since our founding in 2010, we have aspired to build the leading mRNA technology platform, the infrastructure to reimagine how medicines are created and delivered, and a world-class team. We believe in giving our people a platform to change medicine and an opportunity to change the world.

By living our mission, values, and mindsets every day, our people are the driving force behind our scientific progress and our culture. Together, we are creating a culture of belonging and building an organization that cares deeply for our patients, our employees, the environment, and our communities.

We are proud to have been recognized as a Science Magazine Top Biopharma Employer, a Fast Company Best Workplace for Innovators, and a Great Place to Work in the U.S.

If you want to make a difference and join a team that is changing the future of medicine, we invite you to visit modernatx.com/careers to learn more about our current opportunities.

Our Working Model

As we build our company, we have always believed an in-person culture is critical to our success. Moderna champions the significant benefits of in-office collaboration by embracing a 70/30 work model. This 70% in-office structure helps to foster a culture rich in innovation, teamwork, and direct mentorship. Join us in shaping a world where every interaction is an opportunity to learn, contribute, and make a meaningful impact.

Moderna is a smoke-free, alcohol-free, and drug-free work environment.

Equal Opportunities

Moderna is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry or citizenship, ethnicity, disability, military or protected veteran status, genetic information, sexual orientation, marital or familial status, or any other personal characteristic protected under applicable law.Moderna is a place where everyone can grow. If you meet the Basic Qualifications for the role and you would be excited to contribute to our mission every day, please apply!

Moderna is an E-Verify Employer in the United States. We consider qualified applicants regardless of criminal histories, consistent with legal requirements.

Accommodations

We’re focused on attracting, retaining, developing, and advancing our employees. By cultivating a workplace that values diverse experiences, backgrounds, and ideas, we create an environment where every employee can contribute their best.

Moderna is committed to offering reasonable accommodations to qualified job applicants with disabilities. Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should contact the Accommodations team at [e-mail].