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.
The Medical Director will provide clinical support to one or more Clinical Project Teams to ensure the successful design and implementation of Clinical Development Plans. This position will report jointly to the Head of Clinical Development and Head of Development
Operations. Major areas of responsibility include clinical trial design, medical monitoring of Akcea-sponsored clinical trials, clinical data analysis, internal and external communication of project information and plans and contributions to regulatory submissions,
publications and presentations.
- Lead the creation of clinical strategies and development plans for assigned programs in Phase I, II, or III of development, in consultation with cross-functional team members and outside consultants, to meet all requirements of the product development strategy
- Assist in the design of clinical trials and writing/review of clinical protocols and other critical study documents (Investigator Brochures, IND submissions, Clinical Study Reports, NDAs, etc.)
- Provide ongoing medical monitoring for clinical trials including but not limited to assessment of eligibility criteria, toxicity management, and drug safety surveillance
- Lead implementation of pharmacovigilance activities including SOPs and procedures for preparation of SAE narratives and creation of cumulative safety databases
- Play a key role in the development of analysis plans, and in the review, interpretation and communication of clinical trial data from Phase I to III safety and efficacy trials; assist in generating the study reports and publications from these trials
- Participate in and lead investigator meetings
- Provide clinical, scientific and development expertise to regulatory activities as needed
- Provide clinical, scientific and development expertise to business development initiatives as needed
- Interact with external medical/scientific advisors, thought leaders and clinical investigators in the therapeutic area and with internal management and drug development staff to prepare/revise/maintain and efficiently execute the drug development plan
- Assist in developing external advocates for the company’s technology, products, and direction
- Facilitate the effective conduct of clinical trials:
- Develop and maintain excellent working relationships with investigators
- Ensure that all GCP requirements are consistently met
- Deliver high quality scientific presentations on company technology, investigational agents and/or clinical study issues to investigators and clinical site staff
- Provide guidance and/or training for external personnel/parties involved in Akcea’s clinical studies
- Perform clinical study data review and analyses in conjunction with Biometrics
- Support the Clinical Scientist and provide clinical education support for internal company customers
- Facilitate, assist and/or participate in the preparation of clinical study manuscripts by Investigators, internal personnel, and/or contract writers
- Maintain clinical and technical expertise in the therapeutic area; review scientific journals, attend scientific and key technical meetings and partner with company medical, research and commercial teams
- Assist in accomplishing department and corporate objectives
- Other duties as assigned
- MD required; clinical practice and drug development experience highly preferred
- Training in internal medicine or endocrinology with lipid management experience highly preferred
- Previous industry experience as a study medical monitor or pharmacovigilance monitor or medical affairs role is preferred
- Experience conducting clinical trials in lipid space is preferred
- Advanced knowledge of Good Clinical Practice (GCP) for conduct of clinical studies and associated FDA regulations for pharmacovigilance/safety reporting is required; international experience with safety reporting for foreign regulatory agencies is preferred
- Experience with technical writing of clinical sections for FDA dossiers, study reports, clinical protocols, and SAE narratives is preferred
- Excellent written and oral communication skills are required; good presentation skills and ability to prepare clinical data presentations is preferred
- Strong interpersonal skills and entrepreneurial can-do attitude is essential
- Willingness and ability to travel up to 25% of time, including domestic and international travel
Excellent salary and benefits package offered.
For more information on Akcea and to apply for this position, please visit our website: www.akceatx.com
NO PHONE CALLS PLEASE. PRINCIPALS ONLY.
Akcea Therapeutics, Inc. is proud to be an EEO employer.