Lediga jobb Calliditas Therapeutics AB i Stockholm

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. We have our headquarters in Stockholm, Sweden and offices in the USA, Switzerland and France.

Calliditas’ lead product, Tarpeyo™, 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 were no approved treatments.

As of December 2021, the FDA has approved the commercialization of Nefecon (TARPEYO™) in the United States thus making it the first and only FDA-approved treatment and in May 2022 Calliditas received a positive opinion for the drug from CHMP in the EU. Calliditas is listed on Nasdaq Stockholm (ticker: CALTX) and the Nasdaq Global Select Market (ticker: CALT). Visit www.calliditas.com for further information.

The role

The Director of Medical Affairs 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 Stockholm office so the greater Stockholm metro area candidates are preferred.

Main responsibilities

- Assist the VP of Medical Affairs in developing the vision, strategy, direction, and operating plans for 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.
- Lead and provide expertise in the planning, development, and review of all publications, including abstracts, posters, slides, and manuscripts for all Calliditas programs in collaboration with VP Medical Affais and clinical development colleagues.
- Engage in scientific exchange with a wide variety of healthcare professionals 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.
- 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 medical and development objectives.
- Establish and maintain relationships with relevant medical professional organizations/societies.
- Assist VP of Medical Affairs to partner with Legal/Compliance/Regulatory/Commercial to implement in the promotional and non-promotional review process that meets all relevant legal/regulatory standards.
- Assist VP of Medical Affairs in developing and managing a budget for publications.
- 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, and 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.

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.
- Significant experience in publications process and execution
- 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 within specialty products with strong growth ambitions and a strong pipeline
- Be a part of the commercialization of TARPEYO™ in the US and Nefecon via partners in other countries
- 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! Visa mindre

About us

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 (http://www.calliditas.com) for further information.

Position summary

Join us as our new Regulatory and Quality Assistant and become part of an exciting environment. Our colleagues in Regulatory and Quality have a unique combination of scientific insight, patient focus, and the ability to navigate many agendas and different internal and external stakeholders. That makes these two areas a truly interesting and challenging place to work.

As Regulatory and Quality Assistant you will be supporting both the Regulatory Affairs (RA) and the Quality Assurance (QA) functions. You will report to the Head of Regulatory Affairs, but in the daily work you will be a part of both areas.

Key tasks and responsibilities

- Aid and support the regulatory submissions and quality documents from the preparation phase, through completion to archiving.
- Aid and support amongst other registration, documentation, corrective/preventive actions related to products, processes, projects, suppliers, and partners.
- Coordinate registration and reporting of monitoring and follow-ups related to regulatory and quality business processes.
- Provide administration and support to users of the clients’ document management systems, Veeva Quality Docs and Veeva RIM.
- Coordinate, perform and follow up periodic audits owned by the departments of Quality Assurance and Regulatory Affairs and completion of documentation of the activities related to the customer's quality management system, products, internal and external audits, suppliers and partners.


Education and experience requirements

We’re looking for you who have at least a completed high school degree. It is highly meritorious if you have previously worked in a similar position and industry or an industry similar to medical equipment. Furthermore, you should have experience in computerized systems for information handling and documentation, good knowledge of Microsoft Office, excel for example, and be fluent in English and be comfortable both in speaking and writing in English. As a person, you must be thorough, flexible and driven. You must also be pedagogical and have a great ability in prioritizing your work. You must also enjoy a working environment where a lot is going on and where you need to juggle many things at once.

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


Are you the person we’re describing above? Then take this chance and apply for the position immediately!

Welcome to join the Calliditas Team! Visa mindre

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. We have our headquarters in Stockholm, Sweden and offices in USA, Switzerland and France.

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 (http://www.calliditas.com/) for further information.

Position summary

Join us as our new Clinical Trial Assistant and become part of an exciting global environment. You will be a part of a group of colleagues having a unique combination of scientific insight, patient focus, and the ability to navigate many agendas and different internal and external stakeholders.

In this role you will support the Clinical Operations Department and work closely with our Clinical Operation Leads in the day-to-day work of sponsor study planning, execution and reporting of clinical trials and clinical study oversight activities of Contract Research Organizations.

You will work with document management of processes of , e.g., study documents, TMFs, QC checks, monitoring. compliance, etc. In this role, you will truly be a part of the company’s journey in addressing niche indications with high unmet medical needs.

Key tasks and responsibilities

- Provide general administrative support and assistance to the internal project team, primarily the Clinical Operation Leads.

- Support the internal project team with ongoing conduct of studies including coordination of administrative tasks during the study process

- Contribute to applications & submissions by handling clinical-regulatory documents

- Assist in contact with clinical sites for specific requests (e.g., enrollment updates, missing documentation, meeting arrangements)

- Attend clinical project team meetings

- Set up, organize, and maintain clinical study documentation in the trial master file

- Quality control of and archival of the TMF after final study

- Contribute to development and improvements of processes within the clinical operational area, e.g., SOP writing and/or revisions, development of sponsor oversight tools, checklists, etc.

- Contribute to quality GCP compliance related activities and audit/inspection readiness

Education and experience requirements

We’re looking for you who have at least a completed high school degree and a minimum of five (5) years of experience of working with Clinical Research. Furthermore, you should have experience in computerized systems for information handling and documentation, good knowledge of Microsoft Office, excel for example, and be fluent in English and be comfortable both speaking and writing in English.

As a person, you must be thorough, flexible, and highly self-motivated. You can prioritize your work in an efficient manner and are not afraid of taking initiatives. To thrive in this role, we believe you enjoy a fast-paced working environment, where a lot is going on and where you need to juggle many things at once.

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
- Be a part of developing medicines for rare liver diseases
- Get in on bonus and benefit programs
- Fast paced small company environment


Welcome to join the Calliditas Team! Visa mindre

About us

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 (http://www.calliditas.com) for further information.

Position summary

As Head of Biometrics at Calliditas Therapeutics you will be responsible for creating and implementing the strategic direction for biostatistics, programming, and data management activities across all projects, in all phases of development. You will also be responsible for developing functional infrastructure and building biometric capabilities at Calliditas and, in collaboration with the Chief Medical Officer, will set or significantly influence the long-term strategic direction for Biometrics, in line with the company’s broader clinical development strategy.

Key capabilities

- Demonstrates a long-term perspective that extends beyond the immediate initiatives; visualizes and articulates a clear direction for Calliditas Biometrics.
- Ability to clearly communicate complex statistical concepts and analysis outcomes in both written and oral communication, and competence in presenting to a wide variety of audiences including internal teams and external medical/scientific communities.
- Proven leadership ability, and demonstrated ability to work as a senior team member, engaging and influencing team members.
- Demonstrated problem-solving skills (including taking ownership to ensure timely resolution), a strong sense of urgency, keen attention to detail, and the ability to successfully execute in an environment under time and resource pressures.
- Strong interpersonal and communication skills, including fluency in written and spoken English.
- Lives the leadership behaviors of Calliditas employees: be positive, be accountable, be results-oriented and be an excellent manager of self and others.


Education and experience requirements

- Masters or PhD in statistics or related field
- 15+ years of experience in pharmaceutical, biotech, medical device industry or equivalent; global experience preferred.
- Experience leading a statistical or biometrics function is preferred.
- Experience in rare diseases is an advantage.
- Significant experience interacting with regulatory agencies.
- Prior people management experience and experience identifying organizational needs (talent, process, technology) are strongly preferred.


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! Visa mindre