Associate Director, Bioanalytical Chemistry

Job Description

POSITION OVERVIEW:

With considerable independence, you will typically lead development and execution of bioanalytical plans for large molecule bioanalytical method development, method validation, and clinical study sample analyses, which range from first-in human through approval and post-marketing activities and are generally conducted through CROs. These activities include, but are not limited to, collaboration on functional area activities during program implementation, bioanalytical design and input into clinical study protocols, bioanalytical method development, method validation, sample analysis, guidance and coordination with internal cross-functional partners and CROs, and bioanalytical input into clinical study reporting and regulatory filings. You will typically play a lead scientific role, which will entail coordinating and providing direction to internal and external partners involved in bioanalytical design and execution. You will deliver new scientific or technological ideas that advance our progress.

EXAMPLE RESPONSIBILITIES:

• Provides input into product development strategies and/or research or clinical development plans for assigned products / projects.
• Leads and manages design and conduct of bioanalytical activities for protein therapeutics (including PK, ADA and NAb) of moderate complexity, which typically includes responsibilities for acting as a member of the respective cross-functional study team.
• Provides bioanalytical input into clinical study protocols.
• Works with cross-functional partners and CROs to implement and monitor bioanalytical activities. Coordinates with cross-functional partners 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 documentation, data analysis / management plans and scientific presentations or literature.
• Manages timelines and resources to ensure timely and accurate execution of bioanalytical activities.
• Presents project updates and other key milestone information to cross-functional partners and stakeholders.
• Anticipates problems that may arise in clinical studies and develops solutions for these using precedents, collaboration and original thinking.
• Develops bioanalytical inputs into regulatory documentation.
• May participate in contributing to scientific literature and conferences through publication and presentation of results.
• Provides matrix management and leadership to multiple or larger-scale projects.
• Adheres to regulatory requirements of study conduct, scientific principles, industry standards, and Gilead SOPs, and where applicable ensures the same across own team.

REQUIREMENTS:

We are all different, yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.

Minimum Education & Experience

• PhD in biochemistry, pharmaceutical sciences, computational biology or related discipline with 2+years’ relevant experience in development and / or application of bioanalytical assays methods for drugs in the biopharma industry, healthcare, consulting, academia or a related environment.
• MS in biochemistry, pharmaceutical sciences, computational biology or related discipline with 8+ years’ relevant bioanalytical assay methods experience.
• BA/BS in biochemistry, pharmaceutical sciences, computational biology or related discipline with 10+ years’ relevant bioanalytical assay methods experience.
• Experience working with various techniques associated with the collection and analysis of biological samples for analytes such as ELISA, ECL, LC-MS, HPLC, Gyros, etc.
• Knowledge of immunogenicity and recent regulatory guidelines on immunogenicity method requirements.
• Experience applying global regulatory requirements for bioanalysis of drugs or related substances.
• Significant experience working on and with cross-functional project / program teams in drug research or development.
• Multiple years’ experience supporting bioanalytical method design and validation, clinical study sample analysis and regulatory filings.
• Experience writing scripts with Phyton, R and similar programming languages is preferred.
• Experience supporting scientific publications and presentations is preferred.
• Demonstrated abilities to effectively lead and manage CROs

Knowledge & Other Requirements

• Able to manage scientific, operational and administrative aspects of projects.
• Proven analytical abilities as demonstrated through past experience and/or academic research.
• Knowledge of FDA and EMA regulations, ICH guidelines, GCP and familiarity with standard clinical procedures.
• Understands cross-functional roles and responsibilities in the design, conduct and close-out of clinical studies.
• Demonstrates technical proficiency, scientific creativity, collaboration with others and independent thought in suggesting bioanalytical approaches and techniques.
• Demonstrates knowledge of how an assigned project fits into the broader strategic goals of the company.
• Demonstrates technical understanding of bioanalytical workflows, including sample analysis strategies, instrumentation and general laboratory operations with familiarity of pharmacokinetics in drug development.
• Demonstrates understanding of factors affecting the precision, accuracy and reliability of bioanalytical assays, including the available options for mathematical / statistical treatment of data from such methods.
• Knowledge of immunoassay techniques is required, and chromatography and mass spectrometric techniques is preferred.
• Strong communication and organizational skills.
• When needed, ability to travel for CRO oversight.