Associate Director, NCCP

Some opportunities happen only once in a lifetime - like a job where you have the chance to change lives. At Alexion, people living with rare and devastating diseases are our Guiding Star. We are driven to continuously innovate and create meaningful value in all we do to help patients and families fully live their best lives. We value the uniqueness and diversity of our employees and recognize that nurturing the diverse perspectives and strengths of our people translates into innovative breakthroughs for patients.This is what you will do:The Associate Director, Non-Clinical and Clinical Pharmacology (NCCP) 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.You will be responsible for:* 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 standard industry data analysis software* 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 justification and recommendation for the dose(s) 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.You will need to have:* Doctoral degree (PhD or Equivalent training by experience) in clinical pharmacology, pharmacokinetics, pharmacology, or relevant discipline.* From 5+ 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* The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.We would prefer for you to have:* Foundational academic training in Pharmacokinetic/Pharmacodynamic/ Clinical Therapeutics* Hands-on experience with pharmacokinetic/pharmacodynamic data analyses using standard industry 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 PowerPointLI-SM1Alexion is a global biopharmaceutical company focused on serving patients and families affected by rare diseases and devastating conditions through the discovery, development and commercialization of life-changing medicines. Headquartered in Boston, Massachusetts, Alexion has offices around the globe and serves patients in more than 50 countries. Further information about Alexion can be found at: is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion has taken critical steps to protect colleagues, loved ones, and patients from COVID-19 and its variants. All US-based employees must comply with Alexion''s COVID-19 vaccination mandate. Alexion provides exceptions based on applicable state law as well as reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding a legally required exemption or accommodation, please contact [Click Here to Email Your Resumé]. Alexion participates in E-Verify.As a leading employer in our industry, Alexion offers 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, and much more.AstraZeneca completed its acquisition of Alexion, marking the creation of Alexion, AstraZeneca Rare Disease. If you''re interested in career opportunities with AstraZeneca, click here.

Created: 2025-11-15