Associate Director, Bioanalytics of Clinical Development
Reports to: Director, Bioanalytical Development
Location: Cheshire, CT
Alexion Pharmaceuticals, Inc. is a biopharmaceutical company focused on serving patients with severe and ultra-rare disorders through the innovation, development and commercialization of life-transforming therapeutic products. Alexion is the global leader in complement inhibition and has developed and markets Soliris® (eculizumab) as a treatment for patients with PNH and aHUS, two debilitating, ultra-rare and life-threatening disorders caused by chronic uncontrolled complement activation. Soliris is currently approved in nearly 50 countries for the treatment of PNH, and in the United States, European Union, Japan and other countries for the treatment of aHUS. Alexion is evaluating other potential indications for Soliris in additional severe and ultra-rare disorders beyond PNH and aHUS, and is developing other highly innovative biotechnology product candidates across multiple therapeutic areas. This press release and further information about Alexion Pharmaceuticals, Inc. can be found at: www.alexionpharma.com
. Position Summary
The Associate Director of Bioanalytics of Clinical Development is responsible for leading a bioanalytical (BA) sub-group, managing colleagues, providing scientific input in supporting clinical programs. Responsibilities include:
- Supervise and manage a BA sub-team to support clinical studies that is compliant with GLP and other regulations, and follows regulatory and industry guidance documents;
- Lead bioanalysis for clinical studies, including PK, PD and immunogenicity;
- Lead, evaluate, and review of analytical results and reports from BA, CROs, and work from consultants; approve reports/data from the sub BA team and CROs in coordination with the Senior CRO Manager;
- Responsible for the preparation of BA sections of clinical study protocols, BA laboratory manuals for study protocols, and reports;
- Prepare documents for regulatory submissions on bioanalytics for IND and BLA;
- Contribute to addressing questions and inspections from regulatory agencies.
The incumbent will provide leadership for BA activities; responsible for providing input in the development of bioanalytical protocols, ensuring successful input into the design of assays to support clinical studies, and scientific review and approval of work from CROs and consultants. The incumbent closely collaborate with the heads of Clinical PK/PD, Pharmacometrics and Nonclinical PK/PD and interact with internal departments, including regulatory affairs, clinical operations, biostatistics, data management, project management, toxicology, and research, for the design and execution of bioanalytical components (PK, PD, immunogenicity, biomarkers, etc.) of studies. In addition, the incumbent will contribute to the preparation of the bioanalytical documents for regulatory submission, e.g., IND/BLA and other dossiers. The incumbent will liaise closely with the Senior CRO Manager for work to be done at CROs. Principal Responsibilities
- Lead bioanalysis for clinical studies, including pharmacokinetics, pharmacodynamics, and immunogenicity assessments
- Supervise, manage, and strategic planning for a BA sub-team on objectives and priority setting
- Lead scientific review and provide instruction on bioanalysis from CROs for CRO to provide quality data/reports within specified timelines
- Evaluate work from the bioanalytical sub-team, CROs, contractors, and consultants. Organize project meetings and manage timelines for coordinating BA and CRO work.
- Represent the bioanalytical group to present bioanalytical results to project teams
- Responsible for review and approval of data/report from both BA and CRO labs in coordination with the Senior CRO Manager
- Contribute to the preparation of bioanalytical sections of IND/BLA documents
- Contribute to addressing questions and inspections from the regulatory agencies
- Lead development and technology transfer of BA methods to CROs
- Provide bioanalytical input and collaborate across all functional areas, including research, preclinical, clinical development, project management, biostatics, data management, and regulatory affairs departments.
- Persuasive written and oral communications skills.
- Demonstrate success in technical proficiency, scientific creativity, and collaboration with others and independent thought.
- Scientific know-how: widely recognized expert, maintains high level of professional expertise through familiarity with scientific literature. A driver of innovative scientific research and development on bioanalytics.
- Professionally network with bioanalytical scientists in other pharmaceutical companies to be current with standard practices and regulatory issues facing bioanalytical development
- Integrate quality standards to insure data of the highest quality (e.g. GLP compliance, accuracy, precision).
- Management leadership responsibilities, e.g., coach subordinates on project procedures and mechanisms involved.
- Adhere to GLP/GCP guidelines.
- A minimum of 8 years of pharmaceutical industry experience in supporting bioanalysis in non-clinical and clinical studies
- Strong knowledge in biotherapeutics and bioanalytical area
- Experience in regulatory submissions for IND/IMPD and NDA/BLA
- Experience in managing complex bioanalytical projects and CRO
- Strong management and leadership skills
- Strong knowledge in GLP regulations and regulatory bioanalytical guidance documents that pertain to bioanalytical area
- Excellent written and oral communication skills including good presentation skills
- Leadership skill and capability; has people management experience.
- Hands-on experience with pharmacokinetics, pharmacodynamics, and immunogenicity assay development and validation
- Experience in managing CROs work
- Experience in preparing bioanalytical components of clinical and non-clinical study protocols, study reports
- Experience in preparing bioanalytical regulatory submission documents, e.g., NDA or/and BLA bioanalytical sections.
- Experience in regulatory agency inspection of the bioanalytical laboratory
- Proficient in the use of Microsoft Word, Excel and PowerPoint
- Expect to travel approximately about 15% of the time.
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. To learn more about Alexion, please visit www.alexionpharma.com or download our App for iPhones and Blackberries.
- Doctoral degree (PhD) in biology, biochemistry or relevant discipline
Alexion is an Equal Opportunity /Affirmative action employer