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, TarpeyoTM, 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. As of December 15th 2021, the FDA has approved the commercialization of Nefecon (TARPEYOTM) in the United States thus making it the first and only FDA-approved treatment. 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 Medical Affairs in the United States will provide capabilities to maximize patient benefit from the Company’s products through their safe and effective use through compliant scientific exchange with therapeutic experts and cross-functional internal stakeholders. The Director will collaborate closely with Medical Affairs, R&D, and Commercial teams to provide relevant support in the drug development and commercialization of products.
The position will report to the Vice President of Medical Affairs.
The individual will work primarily from the NYC office so NYC metro area candidates are preferred. Flexibility for remote work is provided in accordance with the current hybrid work model.
Vaccination is a requirement, subject to any religious or medical accommodation.
Key tasks and responsibilities
- Assist the VP of Medical Affairs in developing the vision, strategy, direction, and operating plans for US Medical Affairs programs while assuring alignment with key stakeholders.
- Engages effectively cross-functionally, maximizes functional reporting relationships, and ensures the successful implementation of the Company’s strategy.
- Provide tactical and strategic input into the development plans supporting launch and commercialization.
- Establish a strong partnership with commercial leadership; provide strategic input into commercialization plans in the United States and ensure appropriate alignment between Medical Affairs and Commercial regarding strategy and operational execution.
- Develops and continuously maintains the highest scientific and medical expertise.
- In partnership with the VP of Medical, lead the development of impactful scientific and medical education.
- Co-leads the formation, refinement, and execution of Medical Affairs Phase IV program, if applicable.
- Co-leads Investigator-Initiated research program and process.
- Upon request, provide expertise in the development and review of abstracts, posters, slides, manuscripts, educational materials, investigator-initiated trial protocols, advisory board meeting objectives, medical information letters, scientific/educational grant requests, and patient advocacy grant requests.
- Within the strategic plan; initiate and execute medical engagement and education activities, such as advisory boards, and congress symposia
- Establish and develop relationships with a wide variety of healthcare professionals in the United States to achieve scientific, educational, and patient outcome goals on behalf of the Company
- Serve in peer-to-peer communication with KOLs, working in collaboration with cross-functional colleagues to ensure an aligned and impactful engagement with the healthcare community; ensure that the Company establishes and maintains the highest reputation within the medical community.
- As needed, provide Medical Affairs support of the strategic planning, authoring, and review of manuscripts and other scientific data disclosures
- At times, act as the primary spokesperson for the Company with key opinion leaders at medical conferences and advisory boards, building and maintaining relationships consistent with commercial and development objectives.
- Establish and maintain relationships with relevant medical professional organizations/societies. Partner with Corporate Affairs/Advocacy and Commercial to ensure an aligned and impactful engagement with these groups.
- Collaborate with Commercial to develop appropriate training materials for new employees.
- Assist VP of Medical Affairs to partner with Legal/Compliance/Regulatory/Commercial to create and implement an effective promotional review process that meets all relevant United States’ legal/regulatory standards.
- Assist VP of Medical Affairs in developing and managing a budget for the United States Medical Affairs organization.
- Work with the VP of Medical Affairs to establish a system for measuring the impact of the United States Medical Affairs organization which are reported on a regular basis.
- Work closely with Compliance, Legal, and Regulatory to stay abreast of HCP compliance rules and ensuring that all Medical Affairs activities and services are fully compliant.
- 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.
- Take an active role as a Director to ensure development and delivery of defined targets and initiatives in line with the strategy.
- Ability to travel up to 25%.
Education and experience requirements
Preferred candidates will have:
- MD or PhD degree in life sciences with relevant work experience.
- 8-10 years of Medical Affairs experience in the biotech/pharmaceutical/device industry.
- Proven track record of executing Medical Affairs strategy through successful launches.
- Nephrology experience is desired but not mandatory.
Desired Skills and Qualifications:
- Vision and initiative: Able to envision, catalyze, and build new business processes and infrastructure from the ground up.
- Strategic agility: Processes varying data points and information into a coherent, long term strategic plan.
- Healthy culture: Drives a healthy work environment for his/her team and colleagues. Cultivates an environment that encourages professional development and growth.
- Comfort with ambiguity: Able to work through uncertainty and drive progress while adapting to evolving priorities of the organization.
- Innovation: Creates an environment encouraging innovative thinking and encouraging novel ideas that meet the needs of patients; promotes and manages change to enhance medical affairs capabilities.
- Entrepreneurial: Thrives in a fast-paced, emerging company setting.
- Drive for results: Passionate for achieving and exceeding goals.
- Influence and leadership: Influences without formal authority, able to establish collaborative environment and develop strong rapport with strategic partners.
- Work style: Works collaboratively across expertise areas and functions; seeks to advance higher goals through healthy conflict; highly regarded across stakeholders.
- Planning and organization: Demonstrate excellent organizational skills and attention to detail.
- Communication: Communicates effectively across all levels of the organization and provide updates to the executive team on a regular basis.
Reasons to join the Calliditas Team
- Be a part of a global leader in IgA- Nephropathy and a rapidly growing commercial-stage pharmaceutical company
- Be a part of the commercialization of TARPEYOTM and our focus to file for approval with EMA
- Get in on bonus and benefit programs
- Fast paced small company environment
Welcome to join the Calliditas Team!