Calliditas Therapeutics is a specialty pharmaceutical company based in Stockholm, Sweden focused on identifying, developing and commercializing novel treatments for rare and orphan indications. Our initial focus is on renal and hepatic diseases with significant unmet medical needs. Our lead product candidate, Nefecon, is a proprietary, novel, targeted-release formulation of budesonide for the treatment of the autoimmune renal disease IgA nephropathy, or IgAN, for which there is a high unmet medical need and no approved treatment. Nefecon has received orphan drug designation in both the US and Europe. A global Phase 3 trial of Nefecon in IgAN is ongoing. We plan to submit a NDA with the FDA in Q1 2021 for accelerated approval. Once approved, Calliditas aims to commercialize Nefecon in the US. Calliditas is listed on Nasdaq Stockholm (ticker: CALTX) and the Nasdaq Global Select Market (ticker: CALT). Visit www.calliditas.com for further information.
The Director of Market Access Operations is responsible for the management of trade, distribution, channel, and patient support services to support commercialization of Nefecon and future Calliditas products in the US. This position reports to the Vice President of Market Access and is based in New York, NY, USA.
Key tasks and responsibilities
- Lead development and implementation of statements of work committed by third-party logistics, wholesale, specialty distribution and specialty pharmacy partners, coordinating with internal functions to ensure that our partners customize or establish operations, services, processes, and IT/data specific to the needs of Calliditas and its customers.
- Lead development, implementation, and management of a fully operational patient support services (HUB) program in collaboration with channel partners and market access marketing agency for Nefecon and future Calliditas products, including:
- Development and communication of the patient experience strategy, including critical success factors, key performance indicators and services, with channel partners and internal stakeholders.
- Design of the operating model including location of the HUB and outsource strategy for the specific services offered.
- Design of financial assistance strategy including co-pay and Patient Assistance Program (PAP) that is aligned to industry best practice.
- Delivery of provider billing and coding support as needed.
- Collaboration with cross functional teams on the development of payer, patient, and HCP communication, education, and marketing materials to including digital / web-based media.
- Implementation of CRM system design for patient services, data collection and reporting.
- Delivering high quality data from patient services to integrate with data systems and allow for continual evaluation and improvement and serve as a single point of contact for addressing service gaps in a timely manner.
- Design and implementation of SOP’s, policies, and procedures.
- Collaborate with Sales, Marketing, Supply Chain, IT and Finance to identify and monitor deliverables in key performance indicators related to patient services, specialty pharmacy dispensing and distribution.
- Collaborate with cross functional teams in forecasting, budgeting, and other business analytics to effectively represent sales, initiatives, and patient support functions.
- Develop and manage the operational budgets consistent with the financial goals and objectives of the brands and Company.
- Ensure compliance with corporate policies, procedures, and the company´s code of Business Conduct and Ethics, as well as U.S. healthcare laws and regulations.
Education and experience requirements
- Bachelor's degree and 10+ years of biotech/pharma or related experience with at least 5 years in the strategy and operation of specialty distribution, specialty pharmacy or patient Services.
- Deep understanding of performance and operational indicators for specialty pharmacy provider and patient services HUB functions.
- Strong experience in building out specialty pharmacy provider operations and/or patient services HUB functions from within these environments or as a third party to these environments preferred.
- Advanced analytical skills, and preferably experience in directing and managing activities related to channel and patient services performance reporting.
- Strong experience in commercial pharmaceutical data availability and development of performance-based dashboards that can enable senior executive, commercial management, and sales professional actions in response to analytics and insights.
- Prior work experience with specialty, rare or orphan disease products.
- Demonstrated experience in forecasting and managing budgets.
- Strong collaboration, communication skills and the ability to drive to consensus and influence others that achieve desired results.
- Flexible, innovative, diplomatic, and able to effectively deal with ambiguity.
- Ability to travel as business needs require. Successful experience in fast-paced entrepreneurial environment.
Reasons to join the Calliditas Team
- Be part of a launch team, a growing, fast-paced US organization as we set sights on improving the lives of patients living with rare, orphan conditions.
- Collaborate with a team of experienced, focused and fun colleagues who are truly passionate about Calliditas' mission.
- Be rewarded with competitive salary, bonus and great benefits.