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.
The Assistant Director/Director Scientific Affairs provides medical and scientific, strategic and operational, input into our core medical affairs activities and will work closely and cross functionally and also provides strategic medical input into core product strategies supporting marketing and market access activities.
Key tasks and responsibilities
- Secure highest level of medical, scientific, ethical and compliance standards for the overall medical scientific content, which are also in alignment with the corporate strategy in cross-functional documents and matters.
- Secure high quality scientific input and review process of (as needed): abstracts, posters, slides, manuscripts; educational materials, webcasts, etc.; congress materials, med info letters; commercial materials; scientific educational grants.
- Provide scientific/medical review for promotional and commercial materials, in accordance with regulatory compliance.
- Assume responsibility for the oversight and direction of training with respect to medical knowledge and scientific developments within the relevant therapeutic areas.
- Support world class launches of all new assets through medical information, scientific publications and other related activities from a process perspective.
- Contribute to the management of issues/crises with a potential impact on patient safety.
- Provide scientific support for advisory boards and steering committee meetings.
- Contribute scientifically to the value dossier and in activities relating to key payer interactions.
- Lead by example through ensuring own compliance with Calliditas policies, values and code of conduct as well as promoting the team to do so.
- Ensure that respective teams are trained and aware of the agreed processes and tools and that they operate in line with them.
Education and experience requirements
- MD or Ph.D. from biosciences.
- 5+ years of biotech or pharmaceutical industry experience working with medical affairs and/or clinical research and development.
- Medical and scientific knowledge from the relevant therapeutic area.
- Strong collaborative experience in working with R&D and commercial. Both medical scientific and technical leadership – with the ability to drive the development and execution of a full scale global medical strategy.
- Strong interpersonal and communication skills (both verbal and written) including the ability to communicate complex medical and clinical concepts.
- Entrepreneurial, innovative and solution oriented approach
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
- Get in on bonus and benefit programs
- Fast paced small company environment
Welcome to join the Calliditas Team!