The Associate Director, Clinical PK-PD is responsible for providing clinical pharmacology input in early (up to proof-of-concept stage) and late-stage clinical development. The incumbent will be responsible for representing clinical pharmacology function on drug development teams, providing input on the dose and the design of early and late-stage clinical trials, and for interacting with the clinicians and the clinical operations group for the execution of the clinical pharmacology components (PK, PD, biomarkers, etc) of the trials. In addition the incumbent will be responsible for performing clinical PK/PD analyses, for providing subject matter leadership related to clinical ADME, pre-clinical to clinical extrapolation and selection of dose/regimen during early development. Additionally, the incumbent will be responsible for providing input on study design and leading the selection of doses for late-stage clinical studies. The incumbent will contribute to the preparation of the regulatory documents such as briefing books for pre-agency meetings, IBs, INDs, and IMPD dossiers, protocols, and clinical study reports. The incumbent will closely collaborate with other development-functions (Toxicology, Bioanalytical, Non-clinical PK/PD, Pharmacometrics and Physiological PK/PD Modeling and Simulation, Biomarkers, Biostatistics and Data Management, Clinical Operations, and Clinical Development) to bring drug candidates from IND stage to NDA. The incumbent will be responsible for working within the department level budget and resources. Support technical due diligence efforts for business development. Willingness to relocate near Alexion US R&D location (Boston, MA) and to travel approximately 10 % of the time.
Responsible for providing support for the preparation of the clinical pharmacology (PK, biomarkers, Bioanalytical) sections of early and late-stage clinical protocols, Clin Pharm development plans, M&S plans
Contribute to the preparation of the pre-IND, IND, IB and IMPD documents
Responsible for the pharmacokinetic and PK/PD data analyses using WinNonlin, NONMEM and/or other softwares
Contribute to the design of early phase clinical trials (FIH to POC) and support project goals
Responsible for recommending the starting dose in FIH trials based on allometric scaling or physiologically based PK modeling
Conduct assessments of relevant exposure vs. response data for supporting dose selection during and post POC
Contribute to the design of late-stage clinical trials (POC-BLA/NDA) and support project goals
Responsible for leading the recommendation for the starting dose in Phase II and III clinical trials based on PK, PD biomarker and efficacy data analysis from previous studies.
Responsible for the preparation of the PK/PD reports and clinical study reports
Represent Clin Pharm function for the project team at the regulatory agencies during regulatory meetings.
Provide clinical pharmacology input and collaborate across all areas of drug development, along with research, preclinical, bioanalytical and clinical development functions.
Work Experience (Years, setting, etc.)
Around 5-10 years of pertinent post-doctoral experience in supporting pharmacokinetics, pharmacodynamics and other clinical pharmacology components of early clinical trials within the pharmaceutical or biotech industry.
Exposure to biologics drug development. Knowledge of basic and clinical immunology is plus.
Hands on knowledge of PK/PD and statistical analyses methods used in analyzing early clinical phase data
Knowledge of general regulatory process and experience in contributing to IND, EOP1, EOP2, and pre-BLA/NDA meetings with the FDA and EMA
Excellent written and oral communication skills including good presentation skills
Major Skills (Technical & soft skills)
Hands-on experience with pharmacokinetic/pharmacodynamic data analyses using WinNonlin, NONMEM and potentially, other data analysis software.
Experience with performing allometric scaling and making prospective dose/regimen recommendations for planned Phase 1, 2 and 3 trials.
Experience in preparing clinical pharmacology components of clinical study protocols and clinical study reports.
Knowledge of current practices and issues in the bioanalytical and drug metabolism areas
Proficient in the use of Microsoft Word, Excel and Powerpoint
Boston, MA, United States
Some opportunities happen only once in a lifetime - like a job where you have the extraordinary opportunity to change lives. At Alexion, such opportunities arise through our unwavering mission to serve patients and families affected by rare diseases. These patients are our guiding star, and we act with integrity, urgency, and discipline because we know their lives are at stake.
Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases through the discovery, development and commercialization of life-changing therapies. As the global leader in complement biology and inhibition for more than 20 years, Alexion has developed and commercializes the first and only approved complement inhibitor to treat patients with paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), and anti-acetylcholine receptor (AchR) antibody-positive generalized myasthenia gravis (gMG). Alexion also has two highly innovative enzyme replacement therapies for patients with life-threatening and ultra-rare metabolic disorders, hypophosphatasia (HPP) and lysosomal acid lipase deficiency (LAL-D). In addition, the company is developing two late-stage therapies, a second complement inhibitor and a copper-binding agent for Wilson disease. Alexion focuses its research efforts on novel molecules and targets in the complement cascade and its development efforts on the core therapeutic areas of hematology, nephrology, neurology, and metabolic disorders. Alexion has been named to the Forbes list of the World's Most Innovative Companies seven years in a row and is headquartered in Boston, Massachusetts' Innovation District. The company also has offices around the globe and serves patients in more than 50 countries.
Alexion's aspiration is to be the most rewarding place to work, where people are empowered to make a difference and where diversity of backgrounds and ideas is encouraged. We are looking for talented individuals who share our passion and commitment to change the lives of patients with rare diseases. We hope you will consider joining our team. Further information about Alexion can be found at: www.alexion.com.
As a leading employer in our industry, Alexion is proud to offer a highly competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families. Benefits include group medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more.
Alexion Pharmaceuticals, Inc.