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 wholly-owned subsidiary of Ionis Pharmaceuticals, Inc. in late 2014 and based in Cambridge, Massachusetts, Akcea was founded with a robust portfolio of development-stage drugs covering multiple targets and disease states using advanced antisense
In the third quarter of 2017, we plan to file for marketing authorization for volanesorsen to treat patients with FCS and are seeking talented professionals to support our efforts.
Medical Director-US Medical Affairs
Reporting into the VP, Global Medical Affairs, and serving as a key member of the Medical Affairs leadership team, the Medical Director-US Medical Affairs will be the in-house Medical Affairs professional responsible for the provision of medical insights
and expertise in the development and execution of key medical affairs activities, including supporting partner functions such as development and commercial.Working in alignment with other Medical Affairs functions (Field Medical, Medical Communications, Medical
Information), the Medical Director will be responsible for the development and execution of select components of the brand plan(s), including KOL engagement (in conjunction with field medical), Managed Access program, registry, and Investigator-Initiated Research
(IIR) planning and oversight.
Primary Position Responsibilities/Tasks
- Lead Medical review of marketing and medical materials on Medical-Legal-Regulatory and medical materials review teams
- Liaise with commercial colleagues and provide expert input into requested and relevant activities and projects including disease state and product materials creation
- Work with market access lead to provide medical insights and assist as required in the preparation and/or review of the product dossiers
- Lead development, execution and oversight of Expanded access program and disease state registry
- Develop, implement and oversee management of IIR processes and strategies
- In conjunction with Field Medical Directors, represent Medical Affairs at congresses, professional association meetings, and other international, national, regional and local events
- Provide strategic and medical input into execution of publication plan, including interfacing with publications lead, medical writer(s) and statisticians to ensure high quality, medically accurate output
- Integrate and align activities and insights with Medical Director(s), Europe to ensure global medical plan execution consistency
- Maintain knowledge of Lipid disorders market place, including knowledge of competitive products, treatment protocols and paradigms, and emerging relevant data and trends
- As required, assist medical writing and medical information in the drafting and finalization of Standard Response Letters (SRLs)
- Interface with regulatory affairs in the development and progression of regulatory documents, including the NDA, NDS, and MAA
- In conjunction with Medical Communications and Field Medical, develop supporting materials (e.g. slide decks) for external medical affairs presentations
- Contribute to the development of internal process for comprehensive collection and analysis of medical and scientific competitive intelligence information. As appropriate, facilitate appropriate internal distribution to medical, legal, regulatory and marketing
- Integrated with Field Medical Directors, interact with Key Opinion Leaders (KOLs) in respective therapeutic area to establish strong scientific presence and value of MA in the medical and academic communities
- Provide expert input in the medical affairs aspects of ongoing and future clinical trials in the Akcea portfolio
- Participate in the evaluation of in-licensing opportunities
- M.D. required- Specialization in Internal Medicine, Cardiology, Gastroenterology or Endocrinology preferred with clinical experience in respective specialty
- 3+ years of experience working in the Pharmaceutical Industry, preferably within Medical Affairs
- Excellent interpersonal skills with demonstrated ability to work with and effectively support cross-functional teams
- Excellent working knowledge of policies and guidance documents related to compliant medical affairs operations, including information dissemination, continuing medical education, and clinical trials
- Expertise and clinical experience in lipid disorders and management
- Demonstrated success in pre-launch medical affairs brand plan development and execution
- Experience in designing and working with patient registries and Expanded Access/Compassionate use programs
Excellent salary and benefits package offered.
Please visit our website, www.akceatx.com, to apply for this position. Reference Requisition #15-0111
NO PHONE CALLS PLEASE. PRINCIPALS ONLY.