Gilead Sciences-posted 1 day ago
Full-time • Director
Foster City, CA
5,001-10,000 employees

At Gilead, we’re creating a healthier world for all people. For more than 35 years, we’ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer – working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world’s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead’s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. Job Description 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 world’s 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 y ou will lead and be responsible for multiple complex bioanalytical programs , which range from first-in human through approval and post-marketing activities and are generally conducted through CROs . Working in collaboration with other groups and functional groups, you will be responsible for various aspects of bioanalytical program activities . 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 be assigned bioanalytical programs of increasing complexity and / or larger scale. You will 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 . You will also assess, identify and recommend state-of-the-art methods for bioanalytical projects.

  • Leads and manages external (CRO) scientists and mentors junior internal team members on the scientific and technical aspects of their work .
  • Routinely p rovides input into product development strategies and/or research or clinical development plans for assigned products / projects.
  • Oversees and manages design and conduct of bioanalytical programs of increasing complexity and / or scale .
  • Ensures timely and appropriate bioanalytical input into clinical study protocols across assigned bioanalytical programs.
  • Ensures timely , effective and appropriate coordination , implementation, monitoring and close-out of bioanalytical activities with cross-functional partners and CROs.
  • Guides and advises others on lifecycle planning and implementation for methods and materials to conduct regulated bioanalytical work at CROs.
  • Ensures timely and thorough management of issues arising from bioanalytical programs , including resolution of assay methods and sample analysis issues.
  • Oversees, reviews and approves clinical study sample analysis and validation and bioanalytical input into study documentation, data analysis / management plans , regulatory filings, and scientific presentations or literature.
  • May serve as an authority on documents used for regulatory filings.
  • Ensures s tudy timelines are met and that bioanalytical programs are appropriately executed.
  • 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.
  • May participate in the authoring and / or implementation of bioanalytical SOPs and related documentation.
  • Adheres to regulatory requirements of study conduct , scientific principles, industry standards , and Gilead SOPs , and ensures the same across own team.
  • PhD in chemistry, pharmaceutical sciences or related discipline with 8 +years’ relevant experience in development and / or application of bioanalytical assays methods for drugs in the pharma or biopharma industry, healthcare, consulting, academia or a related environment.
  • MS in chemistry , pharmaceutical sciences or related discipline with 10 + years ’ relevant bioanalytical assay methods experience.
  • BA/ BS i n chemistry, pharmaceutical sciences or related discipline with 1 2 + 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 desig n and validation, clinical study sample analysis and regulatory filings.
  • Demonstrated abilities to effectively lead and manage a team of direct reports or CROs , either through past effective matrix or line management and/or effectiveness coaching and mentoring less experienced team members.
  • Demonstrated success in directing and advising other internal or external colleagues and/or cross-functional project team members.
  • Recognized for sustained scientific excellence.
  • Thorough understanding of pharmaceutical regulatory requirements and impact on development and execution of clinical trials.
  • A dvanced knowledge of R&D and major disease areas, as evidenced by effectiveness supporting clinical projects.
  • In- depth knowledge of the multidisciplinary functions involved in drug discovery and development and can proactively integrate multiple perspectives into the bioanalytical process .
  • Demonstrable ability to effectively apply business acumen to strategic scientific projects.
  • Demonstrates technical proficiency , scientific creativity, collaboration with others and independent thought in suggesting bioanalytical approaches and techniques.
  • Demonstrates and understanding of bioanalytical work flows , 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.
  • Strong communication and organizational skills .
  • Demonstrable abilities to effectively communicate project direction and status to varying organizational levels, including leadership teams, executives and steering committees.
  • When needed, ability to travel.
  • Experience writing scripts with Phyton, R and similar programming languages is preferred.
  • Experience supporting scientific publications and presentations is preferred.
  • This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package.
  • Benefits include company-sponsored medical, dental, vision, and life insurance plans.
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