About Calliditas Therapeutics
Calliditas Therapeutics is a biopharmaceutical company focused on identifying, developing, and commercializing novel treatments in orphan indications with significant unmet medical needs. Their lead compound, TARPEYO (budesonide), is the first FDA-approved treatment for IgA nephropathy.

With an international presence and a strong growth trajectory, Calliditas is building a world-class team committed to advancing science and delivering innovative therapies that improve patients’ lives. The company culture is entrepreneurial, collaborative, and science-driven, with a strong belief in empowering employees and fostering cross-functional knowledge sharing. In 2024, Calliditas Therapeutics was acquired by Asahi Kasei corporation and the integration is ongoing.

About the role as Associate Director – Project Management
As Associate Director within Project Management, you will be responsible for the direction, implementation, control, and completion of CMC projects from early development through launch and beyond, while ensuring alignment with company strategy, commitments, and goals.

The role oversees outsourced pharmaceutical development, clinical manufacturing, preparations for the commercial manufacturing and supply activities performed at CDMOs for designated projects. You will manage activities performed both internally and through external experts, ensuring delivery of all CMC-related objectives across defined development programs as well as projects for already launched products, such as capacity initiatives and technology transfers
 

Main responsibilities:

–  Lead and execute CMC activities supporting product development, regulatory variations, approvals, and launches across multiple territories.

–  Manage CMC project delivery for key partners, ensuring alignment with timelines and milestones.

–  Prepare and manage Statements of Work and Change Orders.

–  Lead internal and external project meetings and ensure effective follow-up.

–  Oversee project budgets, including forecasting and tracking.

– Monitor development and manufacturing activities at CDMOs to ensure quality and compliance.

–  Provide CMC expertise in risk management, supply activities, and program governance forums.

About you
You bring strong expertise in pharmaceutical development and CMC project leadership, with the ability to manage complex, cross-functional and external partner-driven programs. You are comfortable operating at the interface between development, manufacturing, quality, and supply, and thrive in a matrix, international environment.

Qualifications:

–       Advanced degree in pharmacy, chemistry, engineering, life sciences, or a related field.

–       Significant experience in pharmaceutical development and CMC project management within the pharmaceutical or biotech industry.

–       Proven experience managing CDMOs and outsourced development and manufacturing activities.

–       Strong understanding of pharmaceutical development, clinical and commercial manufacturing, and regulatory requirements.

–       Demonstrated experience in budget ownership, contract management, and vendor negotiations.

–       Solid project management skills, including planning, execution, and risk management.

–       Excellent skills in English, both oral and written.
 

Personal qualities:

–       Strong leadership, communication, and stakeholder management skills.

–       Highly structured, proactive, and detail-oriented with a strong delivery focus.

–       Ability to operate independently while collaborating effectively across functions and organizations.

–       Analytical and solution-oriented mindset with the ability to manage multiple priorities in parallel.
 

Calliditas’ offer
Calliditas offers a dynamic and entrepreneurial environment where you will directly shape the future of their ongoing and future programs. Employees join a growing international company with a strong pipeline, exciting projects, and the opportunity to make a real difference for patients. Calliditas provides competitive compensation, flexible working arrangements, and a culture built on trust, collaboration, and innovation.

Other information
Start: According to agreement
Extent: Full-time
Location: Stockholm

Does this role as Associate Director – Project Management at Calliditas Therapeutics sound like your next challenge? Submit your application today, we at Needo look forward to hearing from you!