Associate Director, Clinical Bioanalysis
Associate Director, Clinical Bioanalysis
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1 Vacancy
Job Description
The Associate Director Clinical Bioanalysis will be responsible and accountable for executing clinical bioanalytical strategies and activities for assigned programs and studies from early through late-stage clinical development and approval including post marketing activities managing outsourcing efforts and collaborating with cross-functional stakeholders including clinical pharmacology DMPK translational medicine clinical development clinical operation biometrics regulatory clinical QA finance and legal. This position will report to the Director Clinical Bioanalysis and work on-site at our Waltham MA office.
What Youll Do:
- Develop and implement bioanalytical strategy for compounds from first-in-human to later phases of clinical development (phase 2 and 3 studies and NDA/MAA submissions) to ensure timely quality and compliant delivery of clinical bioanalytical support.
- Represent the department as bioanalytical subject matter expert on cross-functional study teams and manage and resolve problems or issues relevant to clinical bioanalysis.
- Provide scientific and technical oversight to the bioanalytical vendors on method development/validation/transfer and sample analysis.
- Review bioanalytical contracts review bioanalytical study plans and data provide data transfer agreements review and approve method validation and bioanalytical reports and ensure their regulatory compliance.
- Identify evaluate and select vendors to support quantitative bioanalysis of clinical study samples in a regulated (GLP GCLP) environment.
- Participate in regular vendor meetings build and maintain positive relationships with external vendors.
- Ensure delivery of clinical bioanalysis data and reports with high quality according to timelines.
- Collaborate with colleagues within the department internal stake holders (i.e. data management clinical operations CMC clinical QA procurement legal regulatory etc.).
- Contribute to the preparation and review of relevant sections of clinical and regulatory documents and response to queries from regulatory agency on clinical bioanalysis.
- Contribute to optimizing and improving the operational performance quality and productivity of the function.
Qualifications :
What Youll Bring:
- An advanced degree (PhD) in analytical chemistry organic chemistry biochemistry molecular/cell biology or a closely related scientific discipline.
- 5 years of relevant pharmaceutical industry experience.
- Direct hands-on bench-level experience developing and implementing bioanalytical assays in nucleic acid (antisense oligonucleotide siRNA mRNA gene therapy) and biologics clinical development and approval process with the capability to advise on assay design method development and validation and address any issues that arise during assay development and sample analysis is required.
- Experience and familiarity with current bioanalytical regulatory guidelines are required.
- Strong scientific and technical skills in Ligand Binding Assays and Immunogenicity such as ELISA MSD ECL cell-based methods PCR etc. are required.
- Experience in managing external vendors is highly preferred.
- Experience with writing and reviewing clinical bioanalytical reports and/or contributing to regulatory submissions.
- Organized and detail-oriented with the ability to multi-task and handle multiple projects.
- Excellent written and verbal communication skills and strong negotiation skills.
- Demonstrated ability to work effectively and collaboratively on cross-functional teams.
- Previous experience in small molecule bioanalysis (LC-MS) is a plus.
Additional Information :
Benefits:
- Competitive salary and annual bonus.
- Comprehensive benefits package including medical dental vision insurance 401(k) retirement plan with company match and more.
- Generous parental leave and family planning benefits.
- Outstanding culture and opportunities for personal and professional growth.
Apply Now: Join us in our mission to improve the lives of people with cancer. Apply today to become a part of our dynamic team!
EQUAL EMPLOYMENT OPPORTUNITY INFORMATION
Deciphera is committed to equal employment opportunity and values diversity. To ensure that we comply with reporting requirements we invite you complete the confidential survey at the end of this application. Providing this information is optional. It will not be accessible or used in the hiring process and has no effect on your opportunity for employment. This information will also be treated confidentially. We are committed to make all hiring decisions and other employment decisions on a non-discriminatory basis.
Remote Work :
No
Employment Type :
Full-time
Employment Type
Full-time
