Essential Functions:
In this role, the Senior Bioanalytical Specialist (Consultant /Contractor) will: lead development and execution of bioanalytical plans for small molecule bioanalytical method development, method validation, and clinical study sample analyses, which are generally conducted through CROs. Responsibilities include but not limited to: technical oversight in bioanalytical considerations and methodology design and their implementations into clinical study protocols; serve as a point of contact (POC) interfacing with analytical CROs for their performances in bioanalytical method development, method validation, sample analysis; guidance and coordination with internal cross-functional partners and CROs to assure quality data delivery and timeline; bioanalytical budget proposal and management, and bioanalytical input into clinical study reports and regulatory filings. Successful candidate will be reporting to the Senior Director of Clinical Pharmacology.
Key Responsibilities:
• Provides oversight on planning, designing, development, and validation of GLP-compliant, bioanalytical LC-MS/MS methods for quantification of drugs and metabolites in biological matrices and methods for metabolite identifications to support pharmacokinetic, toxicokinetic, and ADME studies of novel small molecules.
• Works with cross-functional team members and CROs to implement and monitor bioanalytical activities. Coordinates with cross-functional teams to manage lifecycle planning and implementation for methods and materials required to conduct regulated bioanalytical work at CROs. Addresses issues arising from bioanalytical activities, including resolution of assay methods and sample analysis issues.
• Provides bioanalytical input into study documentations (such as study protocol or study report), data analysis / management plans and scientific presentations or literature.
• Manages timelines, budgets, and resources to ensure timely and accurate execution of bioanalytical activities.
• Presents project updates and other key milestone information to cross-functional teams and stakeholders.
• Anticipates problems that may arise during clinical studies and develops solutions for these using precedents, collaboration, and original thinking.
• Develops bioanalytical inputs into regulatory documentation and may serve as an authority for documents used in regulatory filings.
• May participate in the authoring and / or implementation of bioanalytical SOPs and related documentation.
• Demonstrate high level of involvement in continuous improvement of quality assurance philosophy and practices to ensure the highest standards are maintained
Preferred Experience and Education:
· Ph.D. or M.S degree in biology, chemistry, bioanalytical sciences or related discipline with 10-15+ years of relevant biotech/pharma drug discovery/development experience in a team-facing role. Job levels based on candidate’s experiences and qualifications.
· Strong scientific background and scientific aptitude with excellent critical thinking and scientific skills.
· Experience in working with analytical vendors and familiar with a variety of assay platforms using current/innovative technologies.
· Experience in preparing analytical sections supporting IND/NDA submissions using CTD format.
· Has a thorough understanding of GLP/GCP regulations and related US and ex-US regulatory guidance documents.
· Experience with small molecules; prior experience with targeted immunology therapeutics highly desirable.
· Excellent verbal, presentation, and written communication skills.
· Thrives in a collaborative team setting and is driven by a desire to be innovative in a high energy, small company environment.
Salary range:
Principal Scientist- 187 – 209k
Director- 200 – 219k
The pay range for this position that we reasonably expect to pay. Individual compensation is based on various factors including, experience, education, skillset, and geographic location. This range is for the Bay Area, California location and may be adjusted to the labor market in other geographic areas.
DISCLAIMER
The above information in this description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job.