Akcea Therapeutics, Inc. is a development and commercialization company focused on impacting the lives of patients with serious cardiometabolic lipid disorders. Our priority is to bring important new therapeutics to patients in need. In order to do so, we
must drive clinical program execution, understand patient and physician needs and work with regulators to gain global approval and market access to these new therapeutics.
Established as a subsidiary of Ionis Pharmaceuticals, Inc. in late 2014 and based in Cambridge, Massachusetts, Akcea was founded with a portfolio of development-stage drugs covering multiple targets and disease states using advanced antisense
therapeutics. In July 2017, Akcea closed its initial public offering of common stock and is listed on the NASDAQ Global Select Market under the symbol “AKCA.”
Akcea is establishing an Entity in Germany and now wishes to appoint a Country Medical Director for the DACH/CEE region that will work with the regional management team and the international medical team.
Medical Director, DACH/CEE
Major Activities and Responsibilities
· The role will be responsible for all aspects of Medical Affairs including medical support of product launches, leadership of country led studies, KOL mapping and contact, KOL relationship development and will work closely with Commercial , Regulatory,
Pharmacovigilance colleagues and other support service teams e.g., Market Access, Medical Information, Publications. Management of RA, PV and Medical Information is not within the scope of this role.
· Further to team leadership and strategy management, key roles include risk management, scientific input to recalls / alerts, KOL development and Akcea brand building via customer meetings and presentations, colleague training, marketing support and promotional
compliance activities as required.
· To define the Critical Success Factors and Key Performance Indicators for the country team consulting with the International medical team and business colleagues as appropriate.
· Provides leadership, development and management of the Field Medical Team (if applicable) working together to support the Commercial teams. Recruit, train and develop team members; identify and manage talent, enabling team to fulfil their potential. To
coach and support individuals within the team in areas of relevant existing expertise and/or developing responsibility.
· Ensure that all the activities of the team are carried out in a fully compliant manner in accordance with Akcea policies and country laws and regulations.
· Manage the Medical Affairs budget at a country level
· Work alongside the Senior Management Team and other colleagues and commercial teams, undertaking any other duties commensurate with the level of responsibility outlined above, as and when required.
The new incumbent will be expected to drive the following key specific areas through his/her own activity:
· Rising the Disease Awareness and knowledge amongst all healthcare professionals of the relevant therapeutic areas and other decision makers in the relevant HC system via appropriate and well-targeted educational programs
· Support early suitable Patient Identification e.g. via appropriate local studies programs
· Collaborate with HCP and Key Thought Leaders (KTLs) in order to gain further insight regarding the appropriate cohort(s) of patients and adequate screening/diagnostic procedures to improve on otherwise misdiagnosed or undiagnosed patients
· Influence KOLs and associations towards the development or refinement of diagnostic and/or management guideline(s) for Familial Chylomicronemia Syndrome (FCS)
· Build a key opinion leader community around FCS disease to strengthen disease awareness and to support the scientific development in the disease area, the regulatory and reimbursement efforts
· Supporting the development of a market entry plan for Volanesorsen and future products (regulatory, patients advocacy, pharmacovigilance, KOL management, pricing & reimbursement)
· Supporting the reimbursement negotiations with local authorities and liaising with health authorities and payers as required
· Maintenance of up-to-date skills and knowledge regarding scientific medical best practice
· Contribute at local national and international medical conferences and symposia
This senior, pivotal and highly visible position within Akcea will report both into Regional General Manager and Head of Global Medical Affairs in a dual reporting manner.
With responsibility for the Country medical function, the new incumbent will also take part actively in the Akcea International Medical Team and will therefore work closely with the other Medical Directors of Akcea major markets.
Qualifications and Background Requirements
· Medical degree or equivalent
· Strong interpersonal skills. ( Communicative, persuasive)
· Team player. (Collaborative)
· Takes responsibility. (Ownership)
· Projects confidence and integrity. (Presence)
· Works well in ambiguous and challenging environments. (Resilient and Resourceful)
· Respectful of cultural differences. (Empathetic)
· Strategic outlook with tactical capability. (Vision/task balance)
· A passion for helping patients with rare diseases
Professional work Experience
· Demonstrated initiative and an ability to build a market for a new therapy and an Medical organization from inception in the relevant country
· Substantial experience with a leading international life science company within the biopharmaceutical/pharmaceutical industry
· Strong understanding of the respective country’s Health Care system including health technology assessment, regulatory processes and pharmacovigilance requirements
· Thorough experience and confidence when positioning biologic products with selected KOLs and prescribing physicians and hospitals
· Experience in communicating and building relations with authorities, health care sector professionals including specialist care and sales, as well as KOL management
· Strong in delivering well defined measurable results (plan vs. actual)
· International awareness and orientation with very good business acumen
· A competitive compensation package will be presented to the right individual including base salary, bonus, equity and healthcare.
· Based in the Regional office in Munich, Germany
· Domestic and International travel required
Overall, this position reflects an excellent opportunity for an experienced senior Medical Affairs leader, who is ready for a new, exciting challenge to build a function from scratch and establish a new medical community in an area of high medical need.
Excellent salary and benefits package offered.
For more information on Akcea and to apply for this position, please visit our website,
www.akceatx.com. Reference Requisition #17-0056
NO PHONE CALLS PLEASE. PRINCIPALS ONLY.