Ascelia Pharma is an oncology-dedicated drug development company located in Malmö, Sweden, focused on the development of novel drugs to improve the life expectancy and quality of life for people living with cancer.
Ascelia´s strategy is to develop and make available to patients a portfolio of differentiated, underappreciated and de-risked product candidates addressing unmet medical needs in cancer and cancer-related diseases. Ascelia is fully focused on two clinical-stage product candidates under development: Mangoral and Oncoral. The IPO on Nasdaq Stockholm has secured financing for the full Phase III program for Mangoral.
Our lead candidate Mangoral is a liver imaging drug (i.e. a liver specific contrast agent) being developed for detection and localization of potential liver metastases, using Magnetic Resonance Imaging (“MRI”) in patients where use of the current gold standard gadolinium-based contrast agents (“GBCAs”) may be medically inadvisable. Mangoral is the only product targeting this market opportunity of $350-500 million annually and is about to start the registration enabling global phase 3 clinical study. Mangoral has Orphan Drug Designation from the FDA.
Our second drug candidate Oncoral is a novel tablet-based formulation of the well-known chemotherapeutic agent irinotecan, intended for the treatment of advanced gastric (stomach) cancer. Oncoral has completed Phase I studies with encouraging results and preparations for Phase II are ongoing.
Ascelia’s mission - to improve the quality of life expectancy of people living with cancer and cancer-related conditions.
Ascelia’s vision - to make available differentiated orphan medicinal products in oncology that satisfies an unmet medical need.
The company was founded in 2000, is recently listed on Nasdaq Stockholm, Small Cap, March 2019, based in Malmö, and employs 12 people today.
For more information about Ascelia Pharma, please see http://www.ascelia.com
TILLSATT - Director of Regulatory Affairs
Ascelia Pharma is looking for a Director of Regulatory Affairs who will be responsible for the Regulatory Affairs activities globally, with the key near term objectives to obtain NDA / MAA approval for Mangoral and develop a regulatory strategy for Oncoral.
The ideal candidate will be a highly motivated individual with experience and interest in working in a small, entrepreneurial environment with broad responsibilities and opportunities. Experience with the major regulatory agencies and understanding of product development is essential for this role.
The regulatory affairs strategy will be developed together with the management team and a senior consultant with a significant global regulatory affairs experience. In addition to leading the strategic regulatory work the Director of Regulatory Affairs will be responsible for the operational regulatory affairs activities as well as participate in the strategic regulatory work.
The candidate will provide leadership, project management, and program oversight to plan, conduct and secure high-quality regulatory plans and interact with important internal and external stakeholders and regulatory authorities. Therefore, the candidate must be willing to travel.
As the company is small, you must have a “can do” attitude and be comfortable in situations where you are hands-on. Integrity and an independent character are highly valued personality traits and should be combined with the ability to effectively coordinate and inspire team efforts towards meeting stretched goals. The position will report to the Chief Executive Officer.
Responsibilities including but not limited to
• Contribute to the development of the Regulatory Affair strategy together with the management team and a senior consultant and drive the implementation hereof
• Take operational responsibility for all regulatory affairs activities related to Ascelia´s drug candidates
• Take leadership in the planning of regulatory interactions and delegate tasks to various stakeholders
• Responsible for processes related to INDs, NDAs and BLAs as well as associated quality checks
• Serve as regulatory subject matter expert for Ascelia, including FDA, EMA and other regulations and guidance interpretations
• Prepare and ensure a timely and successful NDA / MAA filing and subsequent approval of Mangoral
• Maintaining good regulatory archives as well as good communications with cross functional internal and external teams
• Overall responsible for QA
• Select, contract, and oversee consultants for scientific and/or policy areas of development
• Identify any gaps in company/CRO SOPs and develop internal SOPs as needed
• Bachelor's degree in biochemistry, chemistry, biology or related pharmaceutical field
• Many years of experience in a pharmaceutical or biotechnology regulatory affairs role and preferably leadership of a drug candidate regulatory strategy through approval
• Experience with FDA and EMA a requirement; experience with Asian regulatory authorities a significant advantage
• Experience with IND, CTA and NDA/MAA filings
• Excellent computer skills (Microsoft Office Project, Word, Excel, PowerPoint, Outlook)
• Fluent in oral and written English
• All necessary permits to work in Sweden
• Work collaboratively with cross functional internal and external teams
• Proactive, forward-thinking and a team player with leadership skills to achieve successful outcomes in collaboration with internal team and external collaborators, within budget and in a timely manner
• Demonstrate technical and project management capabilities
• The ability to manage multiple priorities, while maintaining attention to detail is critical
• Ability to operate effectively within a pharmaceutical start-up setting
• Ability to prioritize tasks and resources, meet deadlines, and be flexible to changing priorities
• Strong interpersonal, organizational and workload planning skills along with excellent verbal and written communication skills
• Strong ethical values with high integrity
Opportunities with the role
This is an opportunity to work in a rapidly growing biotech company listed on Nasdaq Stockholm, with short decision-making processes where each employee's contribution is important for the company's development and results. This position includes operational and strategic global aspects and the right candidate will have significant personal and career development opportunities.
For inquires and more information about the position, please contact:
Catharina Herbertsson or Eva Runnerström, Sr Recruitment Consultants at PeakSearch.
firstname.lastname@example.org, +46 (0)706 152 772
email@example.com, +46 (0)701 725 379
Apply for the position at PeakSearch homepage http://www.peaksearch.se or send your cover letter together with your CV directly to either Catharina or Eva, see above.