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.
Senior Medical Director, Drug Safety & Pharmacovigilance.
The Senior Medical Director, Drug Safety will provide medical leadership for clinical safety, pharmacovigilance and risk management activities for assigned Akcea Therapeutics investigational and marketed products. This individual will serve as a member of
the Drug Safety department and function in a company matrix team environment interacting with several key stakeholder groups including; Clinical Development, Medical Affairs, Regulatory Affairs, Quality Assurance, Commercial, Research and Legal.
- Represents Drug Safety in clinical development projects providing expert medical guidance on safety matters for investigational products. Responsible for communicating or producing safety alerts/signals, development risk management plans, reference safety
information and safety evaluations of emergent safety issues.
- Provides medical safety oversight in clinical trials. Participates in protocol development, specifically the collection and monitoring of safety data in interventional and observational studies, medical review of adverse events/SAEs and evaluation of safety
data and statistical analysis planning and reporting of study data.
- Contributes to preparation and review of periodic safety reports (DSUR, EAP Reports)
- Contributes to activities of DSMBs and safety events adjudication committees.
- Contributes to analysis of safety data from on-going and completed studies and their representation in clinical study reports.
- Provides leadership for IB section “Guidance for Investigators” and other safety sections.
- Provides leadership on clinical safety content of country marketing applications e.g. NDA/MAA Clinical Safety Summary and REMS/Risk Management Plan.
- Performs medical review oversight for individual case safety reports (ICSRs) from post-marketing sources.
- Leads product risk management strategy and facilitates production and maintenance of risk management plans.
- Participates in the signal management system with regular review of safety data for assigned products and detection and evaluation of new safety signals.
- Provides medical input to design and maintenance of REMS programs, monitoring of REMS goals and provision of REMS Assessment Reports.
- Leads benefit-risk discussions at the safety governance committee and implementation of risk minimization actions.
- Conducts medical evaluation of relevant safety-related information from toxicology, non-clinical studies, as well as product quality complaints, as needed.
- Contributes to preparation and review of periodic safety reports (FDA Enhanced PV Plan Report, PBRER).
- Participates in leadership oversight of safety vendors and provides back-up for the Head of Drug Safety.
- Participates in continuous improvement activities of self as well as Drug Safety department including systems design and quality management activities.
- Contributes to devlopment of the Drug Safety department via involvement in recruiting/coaching talent and fiscal management.
Qualifications and Experience:
- M.D. with solid knowledge and clinical practice experience of General Medicine.
- Clinical Development experience required.
- 5-7 years pharmacovigilance experience.
Key Skills, Abilities and Competencies
- Competent in safety reviews of clinical safety data/documents including AEs/SAEs, IBs, protocols, clinical study reports and informed consent documents and safety submissions (CTD clinical safety summary).
- Competent in safety reviews of postmarketing safety documents including spontaneous reports and other individual case safety reports (ICSRs), periodic safety reports, risk management plans, company core data sheet
- Knowledge of GVP, GCP, ICH guidance and safety regulations.
- Ability to communicate and collaborate effectively in a matrix environment.
- Excellent written and oral communication skills.
- Good judgment and decision-making skills, including identification and communication of relevant safety-related issues or concerns to Drug Safety Management in an appropriate and timely manner.
- Ability to multi-task.
- Close attention to detail.
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.