Amgen Director-Preclinical, Pharmacokinetics and Drug Metabolism in Thousand Oaks, California
The Director-Preclinical, Pharmacokinetics and Drug Metabolism (PKDM) will report to the Executive Director -PreClinical, PKDM and will be located in the Thousand Oaks California location. In this role, the incumbent will lead a team of large molecule bioanalytical scientists with extensive experience in immunoassay bioanalytical platforms to quantitate biotherapeutics in biological matrices to support drug discovery and development programs. The team is responsible for developing, qualifying and validating robust bioanalytical assays for both non-clinical and clinical use with subsequent application in generating bioanalytical data to support critical decisions for the Amgen portfolio within a GxP bioanalytical environment. This role involves strong partnerships be established both within PKDM and across functions including drug safety, clinical development, regulatory and operations.
The primary responsibilities include:
Providing key intellectual contributions and leadership to the scientific and strategic direction of the large molecule bioanalytical team.
Responsible for high quality documentation for regulatory submissions while maintaining compliance with all aspects of GxP regulations for both non-clinical and clinical studies.
Provide bioanalytical guidance and expertise to drive the resolution of high-impact issues across functions and departments within Amgen.
Lead the Large Molecule bioanalytical organization to ensure portfolio deliverables achieved in manner commensurate with the program team timelines.
Anticipate problems and needs across functions/departments with provision of practical and innovative advice or solutions.
Recognized and serve as a scientific and technical thought leader both internally and externally with the ability to solve complex scientific/technical issues.
Drive innovative science within the bioanalytical function towards identifying new technologies and experimental strategies for measuring not only a range of modalities in Biotherapeutics but for Pharmacodynamic (PD) marker and anti-drug antibodies (ADA) measurement.
Provide organizational leadership in supervising and developing a team of approximately 12-15 bioanalytical scientists. Responsible for hiring, developing and retaining a strong talent base within the discipline.
Doctorate degree and 4 years of industry experience
Master's degree and 8 years of industry experience
Bachelor's degree and 10 years of Industry experience
4 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
Ph.D. in relevant scientific discipline and 10+ years of experience in pharmaceutical-biotechnology and/or CRO industry.
High degree of proficiency in large molecule immunoassay based bioanalytical sciences and strong ability to discern/communicate how bioanalysis is utilized in drug discovery and development.
Demonstrated ability in leading and organizing complex project teams and building collaboration across various functions.
Expert understanding of regulatory requirements, including experience with audits and the regulatory submission process.
Experienced in contributing to external sourcing efforts associated with transfer of bioanalytical methodology.
Excellent communication skills with strong ability to present scientific/technical information to diverse audiences.
Highly collaborative and able to work across departments/functions and sites with the objective of achieving what is best for Amgen.
Demonstration of flexibility and agility with a continued desire to learn and evolve both scientifically and organizationally.
Operates with the highest degree of ethics and integrity in carrying out their work.
Committed to enabling the success of others.
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.