Scientific Associate Director - PKDM (Small Molecule ADME)

Amgen•Thousand Oaks, CA

30d

About The Position

Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. Scientific Associate Director - PKDM (Small Molecule ADME) What you will do Let’s do this. Let’s change the world. In this vital and exciting role you will oversee biotransformation activities and can serve as a project team representative focused on small molecule (SM) programs. You will characterize the absorption, distribution, metabolism, excretion (ADME) and pharmacokinetic (PK) properties of SM therapeutic drug candidates to achieve their full pharmacological potential. In this role, your core responsibilities include: Serving as a subject matter expert of small molecule biotransformation and leading biotransformation activities to support the programs and develop strategies to reduce/mitigate risks due to metabolism. Leveraging current biotransformation knowledge of metabolism as well as developing/implementing novel tools to efficiently support biotransformation related activities. Serving as a functional PKDM project team representative (PTR) and subject matter expert on the ADME/PK of small molecule therapeutics, collaborating with scientists across our PKDM scientific community Leveraging specialized ADME/PK skills such as in vitro ADME, in vivo ADME, biotransformation, PK/PD, or physiologically-based pharmacokinetic modeling (PBPK) to impact project progression and decision-making Planning and executing mechanistic ADME/PK analyses to integrate knowledge of drug design parameters, disease pharmacology, physiology, pharmacokinetics and pharmacodynamics to optimize dose selection and preclinical study designs. Contributing to the analysis of pre-clinical ADME and PK data for IND and NDA filings and documenting these analyses in appropriate reports Building close relationships with partner functions and therapeutic areas What we expect of you We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is a subject matter expert with these qualifications.

Requirements

Doctorate degree PhD OR PharmD OR MD [and relevant post-doc where applicable] and 4 years of directly related experience
Master’s degree and 7 years of directly related experience
Bachelor’s degree and 9 years of directly related experience

Nice To Haves

PhD in Pharmacokinetics, Pharmaceutical Sciences, Engineering, or related fields with equivalent professional degrees and 10+ years of experience in the Biotechnology/Pharmaceutical Industry, consulting or post-doctoral training
Candidate should have solid technical experience with the application of SM in vitro/in vivo ADME and pharmacokinetics fundamentals to drug discovery projects
Ability to drive the progression of SM discovery and development within project teams
Establish SM biotransformation and ADME workflows for PKDM scientists.
Expertise with in vitro ADME, in vivo ADME, PK/PD or PBPK
Experience in supporting preclinical components of regulatory documentations.
Excellent interpersonal, technical, and communication skills to lead cross-functional teams
Past experience as a laboratory scientist in a pharma or biotech environment
Excellent written and oral communication skills, attention to detail and accuracy, and interpersonal skills
Record of scientific contributions through peer-reviewed articles and external presentations

Responsibilities

Serving as a subject matter expert of small molecule biotransformation and leading biotransformation activities to support the programs and develop strategies to reduce/mitigate risks due to metabolism.
Leveraging current biotransformation knowledge of metabolism as well as developing/implementing novel tools to efficiently support biotransformation related activities.
Serving as a functional PKDM project team representative (PTR) and subject matter expert on the ADME/PK of small molecule therapeutics, collaborating with scientists across our PKDM scientific community
Leveraging specialized ADME/PK skills such as in vitro ADME, in vivo ADME, biotransformation, PK/PD, or physiologically-based pharmacokinetic modeling (PBPK) to impact project progression and decision-making
Planning and executing mechanistic ADME/PK analyses to integrate knowledge of drug design parameters, disease pharmacology, physiology, pharmacokinetics and pharmacodynamics to optimize dose selection and preclinical study designs.
Contributing to the analysis of pre-clinical ADME and PK data for IND and NDA filings and documenting these analyses in appropriate reports
Building close relationships with partner functions and therapeutic areas

Benefits

A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans
Flexible work models, including remote and hybrid work arrangements, where possible

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