Medical Affairs Director

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, 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.



Your qualifications
To master the position as Medical Affairs Director, we believe that you have at least five years of industry experience and preferably that you, when it comes to therapeutic areas, have experience from oncology related conditions. You have a medical degree (M.D.) or equivalent educational background.
We also believe that you have:
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.
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.

As a colleague, professional and director you:
Have cross-functional team and relationship enhancing skills, with the ability to listen and consult with others, recognize and reward others contribution and build team spirit
Possess very good networking skills, with the ability to communicate effectively with people on different levels, and an ability to manoeuvre between conflict management and disarming situations with a sense of humour.
Demonstrate an outstanding ability to interpret and evaluate scientific, competitive and business-related information critically and objectively.
Are comfortable with presenting information, speaking with stringency, expressing key points and arguments clearly
Possesses a strategic mindset with the ability to see the big picture and demonstrates accountability for a wide range of issues bringing the organization closer to its goals
Delivers high standard with regards to quality and quantity, achieves project goals and focuses on stakeholder needs and satisfaction
Have an entrepreneurial mindset – keeps up to date with competitor information and market trends, identifies business opportunities and demonstrates financial awareness

Other information
Travelling: The position will require travelling up to approx. 30%.
The head office is in Malmö (The Point, Hyllie) and you are preferably able to work primarily from there; other locations considered depending on the candidate. There is an opportunity to work partly from home.
How to apply
Please submit your resumé and cover letter, along with any other material as soon as possible, but no later than December 31st. All applications must be in English and are treated confidentially.
Candidates will be assessed as applications are received. Only candidates considered will be contacted
For more details about the job or the company, please contact Carl Bjartmar, Chief Medical Officer. Phone +46 (0)703 00 12 22 or email cb@ascelia.com
What we offer
At Ascelia Pharma, your skills, dedication, and engagement help us improve the lives of people living with cancer. We offer you an opportunity to be part of a fast-growing company with global reach, where engagement, dedication and results are met with opportunities for individual and professional development.
Join us on our journey to improve patients’ lives and build a global orphan oncology life science organization.