We are looking for a self-motivated and ambitious clinical operations lead to join the Calliditas team. You will be responsible for the execution of a clinical trial through its duration, from study design, to execution, to study close out. You will also be in a leadership position, and will maintain oversight for cross-functional teams of external partners and to work with other clinical team members, clinical vendors and consultants, and to ensure that all assigned operational trial deliverables are met.
Key tasks and responsibilities
- Assume responsibility for the study timelines, study budget, and ensuring that the delivery of clinical studies is effective, to the highest quality, and in accordance with clinical trial regulations, ICH-GCP and SOPs.
- Lead the clinical operational execution of the assigned clinical study; CRO interactions, planning, and successful execution of the study.
- Manage all operational aspects of clinical trials including CRO activities for the assigned clinical study.
- Drive and contribute to all aspects of clinical study operations, including protocol writing, feasibility, vendor selection/start-up, site communication, SDV and data cleaning (in conjunction with the partner CRO), database locks etc.
- Develop operational plans including site co-monitoring strategies, risk mitigation strategies, trial budgets, site selection, clinical supplies management and protocol deviation plans; ensure effective monitoring and execution of the plans
- Ensure all other relevant plans are written, agreed and final prior to study start (e.g., safety monitoring plan, medical monitoring plan, etc.)
- Establish study milestones and ensure accurate tracking and reporting of study metrics such as initial recruitment projections
- Lead the identification of overall study-level risk management activities. Ensure mitigation strategies are implemented effectively.
- Provide clinical operations expertise to ensure operational feasibility and delivery
- Chair operations team meetings and in conjunction with the Head of Clin Ops / CMO organize investigator meetings, monitor training, CRO kick-off meetings.
- Perform ongoing vendor management (e.g., CROs, Central Labs, IxRS, etc.), including negotiation of scope of work, budgets, performance management, and issue resolution
- Ensure study adherence to ICH/GCP and SOPs and ensure clinical project audit and inspection readiness through the study lifecycle
- Oversee set-up and maintenance of study systems including Trial Master File (TMF) etc., and ensure the TMF plan is agreed with relevant operational partners
- Ensure compliance with the clinical trial registry requirements
- Ensure that the investigational medicinal product including forecasts, labelling, packaging and distribution as part of supply chain management are secured.
- In collaboration with Finance, develop and manage the budget for the clinical study/ies.
Education and experience requirements
- Bachelor’s degree or higher in health science preferred
- 10+ years of experience in leading clinical operations teams responsible for successful execution of clinical programs in a pharmaceutical or a biotechnology company.
- Prior experience with managing large global multi-center studies with an understanding of all aspects of Clinical Operations and extensive and proven experience in driving operational delivery to timelines, cost and quality and leading cross-functional study teams
- Extensive knowledge of clinical study management, ICH-GCP, relevant regulatory/ethics requirements and clinical/drug development
- Commitment and proven track record in ensuring the highest quality standards in all aspects of Clinical Operations
- Strong planning and interpersonal skills.
- Experience of working with CROs and vendors, critically evaluating competing proposals.
- Adaptable and able to work in an environment where priorities are constantly changing.
- Excellent computer literacy with working knowledge of PCs, Windows and Microsoft Office applications.
- Fluently communicate in English language, both written and spoken.
Reasons to join the Calliditas Team
- Be a part of a global leader in IgA- Nephropathy and a rapidly growing clinical-stage pharmaceutical company
- Be a part of the completion of the Nefegard trial and our focus to file for approval with the FDA and EMA
- Be part of clinical trials in new therapeutic indications as we continue to grow and expand
- Get in on bonus and benefit programs
- Fast-paced small company environment
Calliditas Therapeutics is a specialty pharmaceutical company based in Stockholm, Sweden focused on identifying, developing and commercializing novel treatments in orphan indications, with an initial focus on renal and hepatic diseases with significant unmet medical needs. Calliditas’ lead product candidate, Nefecon, is a proprietary, novel oral formulation of budesonide, an established, highly potent local immunosuppressant, for the treatment of the autoimmune renal disease IgA nephropathy, or IgAN, for which there is a high unmet medical need and there are no approved treatments. Calliditas is running a global Phase 3 trial within IgAN and, if approved, aims to commercialize Nefecon in the United States. Calliditas is listed on Nasdaq Stockholm (ticker: CALTX) and the Nasdaq Global Select Market (ticker: CALT). Visit www.calliditas.com for further information.
Welcome to join the Calliditas Team!