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 Field Medical Director (FMD) will be the regional director and a scientific resource capable of conducting high-level scientific exchange for disease states with key opinion leaders and internal Calliditas stakeholders. This individual will be responsible for supporting medical education, clinical development, research and health economics and outcomes research for both marketed and pipeline products. The FMD ensures appropriate scientific exchange, develops peer relationships with thought leaders and content experts and provides balanced scientific support to healthcare professionals on behalf of Calliditas in their assigned geographic region. They will develop a deep understanding of the scientific trends associated with kidney and liver diseases, with a focus on IgA Nephropathy. Furthermore, this individual will synthesize their scientific and training insights and communicate with appropriate headquarters-based colleagues (such as clinical development, medical affairs senior management, brand team, managed markets team, investor relations, and business development among others). This individual will report directly into the Director of US Medical Affairs.
The FMD will cover either the Northeast (New York State and the area above) or Northwest (Oregon, Washington, Idaho, Montana and Wyoming).
Key tasks and responsibilities
- Identify key thought leaders and content experts and engage in compliant scientific exchange and balanced discussions across different types of healthcare organizations including: National and regional healthcare systems, integrated delivery systems, payors, and group purchasing organizations in the areas of medical education, clinical, non-clinical and health economics and outcomes research.
- Communicate with Payors and provide medical information pre- and post-approval in accordance with guidance on FDAMA section 114 inherent to Drug Manufacturer Communications with Payor and Formulary Committees. Synergize this communication by collaborating with managed care team.
- Communicate medical insights and feedback gathered from scientific exchange and relevant information in order to define, update and support medical affairs strategies.
- Lead efforts across Medical Affairs to keep abreast of latest scientific, disease state, emerging therapies and healthcare landscape information and use this information to provide value to both external and internal stakeholders.
- Lead development and communication of scientific data to diverse audiences including physicians, pharmacists, nurses and other key stakeholders in hospitals, managed care organizations, government, group purchasing organizations and integrated delivery networks.
- Participate and/or leads teams which drive tactical activities that align with the medical affairs strategy, including product medical strategy, training, research (clinical, non-clinical and health economics and outcomes research [HEOR])
- Continuously ensure the conduct of appropriate and compliant scientific exchange with healthcare professionals.
- Identify and facilitate research opportunities with external investigators that are aligned with the research focus areas of Calliditas.
- Identify opportunities for data generation activities through investigator-initiated research, Registry, and Medical Affairs and/or Clinical company sponsored studies for clinical, non-clinical and HEOR that is aligned with the Calliditas research focus areas.
- Participate in medical writing functions, including drafting and reviewing medical information standard responses, scientific abstracts, publications, scientific slide decks, etc.
- Provide scientific support for the commercial functions of the organization, including providing scientific support to health care practitioners and training for speakers and sales force members as needed.
- Attend and participate in medical/scientific meetings and conferences for the purpose of providing medical information booth coverage and/or keeping informed of latest scientific data and healthcare evolutions to provide insights that inform strategic directions.
- Lead and facilitate advisory boards and other activities that inform strategic directions.
- Maintain cross-functional collaboration with internal peers and field teams to provide scientific expertise and function as a scientific advisor with Clinical Research, Clinical Affairs, Commercial, Investor Relations, Business Development, Corporate communications, etc.
- Use technical expertise to support team and departmental projects.
- Take responsibility for delivery of Medical Affairs goals and other company goals as assigned.
Education and experience requirements
Preferred candidates will have:
- PhD, MD, or PharmD, (D Degree preferred)
- Experience in clinical and practical patient care or industry experience in cardio-renal, hepatic and orphan diseases
- A demonstrated ability to educate as well as develop and maintain credible and scientific relationships with health care providers
- 2 years of experience in biopharmaceutical industry
- Small pharma and/or new product launch experience
- The motivation to be a part of a unique start-up with a new scientific platform
- The understanding and flexibility to work well with the complexity of a start up company
- High business acumen and impactful communication skills
- The ability to balance priorities and complete multiple projects in a timely manner
- The willingness and enthusiasm to travel 40-60% of the time, and to be available to work evenings and weekends as needed for medical meeting coverage and other activities
Vision and initiative: Able to envision, catalyze, and build new business processes and infrastructure from the ground up.
Desired Skills and Qualifications:
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 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!
Vaccination is a requirement, subject to any religious or medical accommodation.