Do you want to be part of Ascelia Pharma – an ambitious and dedicated Malmö based biotech company focused on rare oncology indications? We develop and commercialize novel drugs that address unmet medical needs and have a clear development and market pathway.
We aim to further expand our drug pipeline in therapeutic areas that leverage our unique expertise in taking orphan oncology drugs through clinical stage development and commercialization.
We are looking for a Medical Affairs Director with a passion and creativity to develop great drugs for oncology related conditions. You will join a journey in building and growing the company aiming at improving the lives of patients with rare oncology related diseases.
With direct report to the Chief Medical Officer, you will be responsible for medical affairs activities for two programs within the clinical development and commercialization stages. You will be a key player in a fast-growing cross-functional team and work closely with the Chief Commercial Officer, Director of Regulatory Affairs, the Project Director, Director of Clinical Operations, and colleagues across the organization.
Your main tasks
- Responsible for developing and executing the medical affairs strategy for two orphan oncology programs. Ensures cross-functional alignment and organizational support for the medical affairs program.
- Act as disease expert. Activities range from internal training, seeing that external questions are addressed, and providing informational services to health care providers in the community with focus on the US.
- Manages and tracks implementation of publications plans, and the reporting of trial results at scientific meetings and through journal articles.
- Manages Scientific Advisory Board activities, provides information and other support to persons who are recognized experts in their fields, as well as supports thought leader development.
- Involvement in all stages of clinical development including study design, initiation, and oversight.
- Provide strategic input on the design and implementation of investigator-initiated trials.
- Act as liaison to health care professionals and professional organizations, and disease state and clinical guidelines advocacy groups. Supports the efforts of professional associations, patient support groups, and educational foundations.
- Contribute to product development and launch preparation and execution, provides medical review / approval of promotional materials for scientific meetings, symposia, and other Medical Education activities, in accordance with applicable Codes of Practice and regulations.
- Supports development of material and dialogue with payers and reimbursement policy makers.
- Assists in the development of lifecycle management plans and new claims and preparing responses to competitor actions and communication.
- Collaborate with regulatory colleagues and legal consultants to ensure that all written documents are accurate and adhere to the guidelines mandated by regulators.
- Assists in writing and amending SPCs (Summary of Product Characteristics), PILs (Patient Information Leaflets) and label information.
- Medical degree (M.D.) preferred with minimum 5 years of industry experience.
- Relevant knowledge in the therapeutic areas. Experience working in oncology related conditions preferred.
- Excellent communication skills.
- Good knowledge of global healthcare systems, including US.
- A high level of knowledge of regulatory environment including key regulatory agencies and approval processes, including US.
- Cross-functional team and relationship enhancing skills.
- Previous work and leadership experience in international and multidisciplinary drug development teams and broad understanding of drug development process.
- Understands preclinical, clinical, regulatory, and commercial functions, as well as business strategy and business requirements.
- Outstanding ability to critically and objectively interpret and evaluate scientific, competitive and business-related information.
Travelling: The position will require travelling up to approx. 30% (tbd).
Work location: Preferably able to work primarily from the head office; other locations considered depending on the candidate.
Domicile: Hyllie Boulevard 34, 215 32 Malmö, Sweden
How to apply
Please submit your resume and cover letter, along with any other material, using the form below.
All applications must be in English and are treated confidentially.
Candidates will be assessed as applications are received.
For more details about the job or the company, please contact:
Chief Medical Officer
Phone +46 (0)703 00 12 22