Director, Bioanalytical Chemistry

At Gilead our pursuit of a healthier world for all people has yielded a cure for hepatitis C revolutionary improvements in HIV

treatment and prevention as well as advancements in therapies for viral and inflammatory diseases and certain cancers.

We set and achieve bold ambitions in our fight against the worlds most devastating diseases united in our commitment to

confronting the largest public health challenges of our day and improving the lives of patients for generations to come.

As a Director Bioanalytical Chemistry at Gilead you will you will lead andbe responsible formultiple complexbioanalyticalprograms which range from first-in human through approval and post-marketing activitiesand aregenerally conductedthrough CROs. Working in collaboration withother groups and functional groups youwillberesponsible forvarious aspects ofbioanalyticalprogram activities. These activities include but are not limited to collaboration on functional area activities during program implementationbioanalytical design and input into clinical study protocols bioanalytical method development method validation sample analysisguidanceand coordination with internal cross-functional partners and CROs and bioanalytical input into clinical study reporting and regulatory filings.You will typically be assigned bioanalytical programs of increasing complexity and / or larger scale.You will play a lead scientific role whichwill entail coordinating and providing direction to internal and external partners involved in bioanalytical design and execution.You will delivernew scientific or technological ideas that advance our progress.You will alsoassessidentifyand recommendstate-of-the-artmethods for bioanalytical projects.

EXAMPLE RESPONSIBILITIES:

• Leads and managesexternal (CRO)scientistsand mentors juniorinternalteammemberson thescientific and technical aspects of their work.

• Routinely providesinput into product development strategies and/or research or clinical development plans for assigned products / projects.

• Oversees and managesdesign and conduct of bioanalyticalprogramsofincreasing complexity and / or scale.

• Ensurestimelyandappropriatebioanalyticalinput into clinical study protocolsacross assigned bioanalytical programs.

• Ensurestimelyeffectiveandappropriate coordination implementationmonitoringand close-out ofbioanalyticalactivitieswith cross-functional partnersand CROs. Guides andadvisesothers onlifecycle planning and implementationformethods and materialsto conduct regulated bioanalytical work at CROs.Ensurestimelyand thorough management ofissues arising from bioanalyticalprograms including resolution of assay methods and sample analysis issues.

• Overseesreviewsand approvesclinical study sample analysis and validation and bioanalytical input into study documentation data analysis / management plans regulatory filingsand scientific presentations or literature.May serve as an authority on documents used for regulatory filings.

• Ensures study timelinesare met and thatbioanalyticalprogramsare appropriately executed.

• Presents project updates and other key milestone information to cross-functional partners and stakeholders.

• Anticipates problems that may arise in clinical studies anddevelopssolutions for these using precedentscollaborationand original thinking.

• Mayparticipatein the authoringand /or implementation of bioanalytical SOPs and related documentation.

• Adheres to regulatory requirements of study conduct scientific principlesindustry standards andGilead SOPs and ensures the same acrossownteam.

REQUIREMENTS:

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

Minimum Education & Experience

• PhD in chemistry pharmaceuticalsciencesor related discipline with8yearsrelevant experience in development and / or application of bioanalytical assaysmethodsfordrugsin thepharma orbiopharma industry healthcare consultingacademiaor a related environment.

• MSin chemistry pharmaceuticalsciencesor related disciplinewith10 yearsrelevantbioanalytical assaymethodsexperience.

• BA/BSinchemistrypharmaceuticalsciencesor related disciplinewith12 yearsrelevantbioanalytical assaymethodsexperience.

• Experience working with various techniques associated with the collection and analysis of biological samples for analytessuch 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 experienceworking on and with cross-functional project / program teams in drug research or development.

• Multiple years experience supportingbioanalyticalmethoddesign and validation clinical study sampleanalysisand regulatory filings.

• Experiencewriting scriptswith Phyton R and similar programming languagesis preferred.

• Experience supportingscientificpublications and presentations is preferred.

• Demonstrated abilities to effectively lead and manage a team of direct reportsor CROs either through past effective matrix or line management and/oreffectivenesscoaching and mentoring less experienced team members.

• Demonstrated success in directing and advising otherinternal or externalcolleagues and/or cross-functional project team members.

Knowledge & Other Requirements

• Recognized for sustained scientific excellence.

• Thoroughunderstanding of pharmaceutical regulatory requirements and impact on development and execution of clinical trials.

• Advanced knowledge of R&D and major disease areas asevidencedby effectiveness supporting clinical projects.

• In-depth knowledge of the multidisciplinary functions involved in drug discovery anddevelopment andcan proactively integrate multiple perspectives into the bioanalyticalprocess.

• Demonstrable ability to effectively apply business acumen to strategic scientific projects.

• Demonstrates technicalproficiency scientific creativity collaboration withothersand independent thought in suggesting bioanalyticalapproachesand techniques.

• Demonstratesandunderstanding of bioanalyticalwork flows including sample analysis strategiesinstrumentationand general laboratory operations with familiarity of pharmacokinetics in drug development.

• Demonstrates understanding of factors affecting the precisionaccuracyand reliability of bioanalytical assays including theavailable options formathematical / statistical treatment of data from such methods.

• Strong communicationand organizational skills.Demonstrable abilities to effectively communicate project direction and status to varying organizational levels including leadership teamsexecutivesand steering committees.

• When neededabilityto travel.