Akcea Therapeutics is a biopharmaceutical company focused on developing and commercializing drugs to treat patients with serious rare diseases. 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. Akcea has a portfolio of development-stage drugs covering multiple targets and disease states using advanced
Akcea was established by Ionis Pharmaceuticals in late 2014 and was listed on the NASDAQ stock exchange in July 2017 under the symbol “AKCA.” Akcea is a global company headquartered in Cambridge, MA with offices in Carlsbad, CA and across the EU and Canada.
Vice President, European Medical Affairs
The VP, European Medical Affairs is a critical role for Akcea. Serving in a senior role as the head of medical affairs activities across Europe, and as a member of the European senior leadership team, this person is responsible for translating, localising
and ensuring oversight of the execution of the global medical affairs strategies as well as representing European Medical Affairs on several globally run activities including medical publications, medical information, patient access programs, registries, and
investor-initiated research. Reporting into the VP, Global Medical Affairs with a dotted reporting line into the Head of Europe, the VP, European Medical Affairs will work closely with each of the Country General Managers to ensure all medical needs are met
in a compliant manner. The VP, European Medical Affairs will also be responsible for dotted-line oversight of the European f medical team who report into respective country GMs.
In addition, this position will develop and maintain long-term, credible, peer-to-peer professional relationships with priority medical experts both in the fields of lipidology, neurology, and other medical disciplines related to the management of patients
with targeted diseases (e.g. FCS, FPL) and in the field of hATTR and other medical disciplines related to the management of this condition as well as clinical study investigators.
Primary Position Responsibilities/Tasks:
- Lead Medical Affairs efforts in Europe and serve as the European Akcea Therapeutics Senior Medical Affairs leader.
- Ensure good business conduct and application of relevant local rules and regulation both in spirit and per the code. Responsible for compliance of all European Medical Affairs activities as well as ensuring medical approval for all countries activities.
- Draft relevant policies/guidance documents to enable compliant engagement (based on significant knowledge of each country’s regulations for actions that fall under the medical affairs purview)
- Establishes Akcea as a highly credible partner in the fields of lipidology, neurology, and other medical disciplines related to the management of patients with targeted diseases (e.g. FCS, FPL) and in the field of hATTR. Ensure appropriate training to maintain
exacting high levels of scientific and medical knowledge.
- Build a KOL community around both FCS and hATTR to strengthen disease awareness and to support the scientific development in the disease areas, the regulatory and the reimbursement efforts.
- In conjunction with global patient advocacy supports the development and implementation of strategic engagement / relationship and collaborations with PAGs and patient advocates.
- Serve as medical expert in review and approval of relevant documents, including serving as medical signatory for medical booths and documents/materials for external use in conjunction with GM.
- Responsible for the planning and execution of European patient managed access program plans in accordance with local regulatory framework and in collaboration with the global medical affairs team and the country team.
- Translate global medical affairs plan into the development and regionalisation of country and area-specific medical affairs plans
- Provide significant input to hiring- and serve as “dotted line” manager to medical team (field based and region HQ team will be geographically aligned and report with a “solid line” into respective GM). Support the planning of the evolution of the fast-growing
medical affairs field teams in order to attract, retain and develop our talent.
- Supporting the development of the market entry plans for Akcea pipeline of products (regulatory, patients advocacy, PhIV, KOL management, pricing & reimbursement).
- Provide guidance and support to market access/health technology appraisals/dossier development and payer stakeholder engagement.
- Supports market access through innovative design and execution of trials to fill data gaps
- Communicate scientific and outcomes data to payers to enable favorable formulary positioning
- Partners with clinical operations on mitigation strategies against patient enrollment challenges
- Develops recommendations for Phase IIIb/IV studies and evidence generation.
- Lead efforts to execute field medical outreach to clinical trial sites
- Vet and evolve the KOL list in conjunction with field based medical team and relevant General Manager
- Serve as European medical representative on global publications team and provide input to Global head, medical communications on medical information function
- Work collaboratively with Country General Managers to evolve and execute European strategy
- Present scientific and medical data to key country influencers
- Represent Akcea at medical conferences, advisory boards, and other meetings (e.g. payer) as required
- Interface and integrate European operations and clinician feedback with US counterpart and VP, Global Medical Affairs
- Present opportunities identified to advance Akcea’s core goals
- Compliantly identify FCS and hATTR patients
- Ability to travel approximately 75% including international travel.
- MD degree with relevant background/experience (e.g. cardiology, lipidology, endocrinology, neurology).
- ≥ 15 years in the medical affairs function in pharmaceutical industry, including leadership roles in Europe.
- Strong understanding of relevant policies guiding the Pharmaceutical Industry within assigned countries.
- Fluent in English with excellent verbal and written communication skills. Additional fluency in European language(s) preferred.
- Excellent understanding of European regional/international health environment.
- High energy, collaborative spirit with strong interpersonal skills.
- Strong experience in leadership roles, including working as individual contributor role in countries with evolving presence.
- Self-starter and entrepreneurial mindset consistent with relatively new and start-up organisations.
- Experience in rare product space, with demonstrated success in new product launches.
- Strong multi-tasking, time management, and organisational skills.
- Ability to take initiative and work both independently and in a team environment.
- Proficient in Microsoft Office applications.
Excellent salary and benefits package offered.
Please visit our website, www.akceatx.com, to apply for this position. Reference Requisition #18-0100
NO PHONE CALLS PLEASE. PRINCIPALS ONLY.