Medical Affairs
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New York
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Fully Remote
Field Medical Director (Northeast territory)
Calliditas, an ambitious pharmaceutical company is growing! To match our exciting growth plans we're looking for new employees to join our journey.
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About us
Calliditas is a commercial stage biopharmaceutical company 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, developed under the name Nefecon, has been granted accelerated approval by the FDA under the trade name TARPEYO®, conditional marketing authorization by the European Commission under the trade name KINPEYGO® and by China’s National Medical Products Administration (NMPA) Nefecon®. TARPEYO, KINPEYGO® and Nefecon® are the first and only treatments approved for IgA nephropathy. Calliditas also has a pipeline in orphan-focused indications. Calliditas is conducting a Phase 2b/3 clinical trial in primary biliary cholangitis and a Phase 2 proof-of-concept trial in head and neck cancer with its NOX inhibitor product candidate, Setanaxib.
Calliditas is led by an experienced and dedicated management team with an average of more than 15 years of prior experience in the pharmaceutical industry, including at leading companies such as GlaxoSmithKline, Pfizer and AstraZeneca. The board of directors includes highly qualified researchers, pharmaceutical sector executives and experts in drug development, corporate development and pharmaceutical commercialization. Calliditas is also supported by its Scientific Steering Committee, a highly regarded network of leading experts, that serve as external advisors and investigators on clinical trials.
Calliditas is listed on Nasdaq Stockholm (CALTX) and Nasdaq Global Select Market (CALT)
Position summary
The Field Medical Director (FMD), which internally has Associate Director status, will be the
regional scientific resource capable of conducting high-level scientific exchange for relevant 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 Head of US Field Medical Affairs.
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.
- Develop and maintain a high level of clinical expertise in IgA Nephropathy and other relevant therapeutic area(s).
- 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 lead 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 opportunities for data generation activities through investigator-initiated research, Registry, and Medical Affairs and/or Clinical company sponsored studies for clinical, nonclinical 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.
- Assist with training Medical Affairs and other cross-functional colleagues on disease state, diagnosis, mechanism of action, and clinical trial data.
- 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
- PhD, MD, or PharmD, (D Degree required)
- Experience in clinical and practical patient care and/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 preferred
- 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 engage in frequent business travel 50-60% of the time, including air travel, ability to travel overnight, and occasionally on weekends.
Reasons to join the Calliditas Team
- Be a part of a global leader in IgA-Nephropathy and a rapidly growing commercial-stage pharmaceutical company within specialty products with strong growth ambitions and a strong pipeline
- Fast paced small company environment
- A unique corporate culture
- Dedicated, experienced and highly skilled colleagues
- Participate on bonus and benefit programs
Welcome to join the Calliditas Team!
Calliditas provides equal employment opportunities to all employees and job applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy or any other legally protected status. For a copy of the Affirmative Action Plan and EEO Statement, contact hr@calliditas.com.
Calliditas is an E-Verify employer.
COVID-19 Vaccination is a requirement, subject to any religious or medical accommodation.
