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.”
ASSOCIATE DIRECTOR, CLINICAL PHARMACOLOGY
The Clinical Pharmacology department is seeking a highly motivated individual to support our aggressive and innovative drug development pipeline. The candidate will be supporting drug development by providing clinical pharmacology expertise across early
and late development phases. The candidate will represent the Clinical Pharmacology expertise on cross-functional teams and influence study design and dose selection.
•Support preclinical and clinical development programs with expert input to study design, evaluations, integrated data analysis and reporting based on clinical pharmacology strategy.
•Perform or oversee PK/PD modeling and exposure-response analysis using a variety of tools and approaches. Integrate, interpret, and report data to project teams and business partners.
•Lead or participate in Clinical Pharmacology or Program sub-teams. Coordinate with appropriate sub-team members and/or prepare summary documentation.
•Contribute expert input into key preclinical and clinical, and regulatory documents including study protocols and reports, PK/PD modeling reports, investigator brochures, IND/IMPD's and NDA's within agreed timelines.
•Attends meetings with external parties including investigators, outside experts, and health authorities.
•Monitor timelines, objectives, and budgets. Ensure rapid and effective communication of high-quality data and results to project teams.
•Work with bioanalytical and modeling and simulation CROs.
•Other duties as assigned
•Ph.D. in pharmacokinetics, pharmaceutical sciences or a related discipline, Pharm D. with appropriate post-doctoral training, or equivalent experience
•At least 6 years of experience in pharmaceutical or biotech industry
•Expert knowledge of pharmacokinetics/pharmacometrics tools (e.g., Phoenix WinNonlin/NLME, NONMEM, R, S-Plus, SAS, Trial Simulator)
•Familiarity of related disciplines (e.g., bioanalytics, biostatistics, toxicology, regulatory) in the drug development process
•Demonstrated experience and ability to work successfully as part of cross functional teams in a highly dynamic, matrixed, project-team environment
•Ability to perform independently and think analytically and creatively to solve problems
•Ability to be productive and successful in an intense work environment
•Excellent oral and written communication skills and interpersonal skills required to enable optimal interactions both internally and externally
•Excellent critical thinking and problem solving skills
•Strong influencing and negotiating skills
•Energetic, self-motivated and a hands-on professional with a strong work ethic
•Demonstrated experience and ability to work successfully as part of cross functional teams in a highly dynamic team environment
Competitive salary and benefits package offered.
Please visit our website, www.akceatx.com, to apply for this position. Reference Requisition #18-0004
NO PHONE CALLS PLEASE. PRINCIPALS ONLY.