Scientific Associate Director, Clinical Pharmacology

Amgen • South San Francisco, CA

17d

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, Clinical Pharmacology What you will do Let's do this. Let's change the world. The Clinical Pharmacology, Modeling & Simulation Department at Amgen is seeking a Scientific Associate Director at its South San Francisco, CA location. In this vital role you will be responsible for the development and implementation of the Clinical Pharmacology and Pharmacometric strategies for cutting-edge innovative therapeutic modalities including Bi-specific T-cell engagers, Bi-specific antibodies, oncolytic viruses, antibody-drug-conjugates as well as traditional small molecules, mono-clonal antibodies and therapeutic peptides. The Scientific Associate Director, Clinical Pharmacology will be a Subject Matter Expert who will apply innovative Quantitative Pharmacokinetic/Pharmacodynamic (PK/PD) approaches and clinical pharmacology strategies and principles to guide optimal drug development. In this vital role, you will be an expert in new drug development and will apply Model-Based Drug Development and principles of quantitative clinical pharmacology to ensure optimal drug development and will represent the Clinical Pharmacology, Modeling & Simulation Department at the global drug development teams. Your expertise will include application of Population PK/PD modeling, Physiologically Based Pharmacokinetic (PBPK) modeling, Mechanistic PK/PD modeling and Quantitative Systems Pharmacology (QSP) modeling to new drug development and you will ensure development of safe & effective dosing regimens for various patient sub-populations & also to ensure optimal new drug development. 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 leader with these qualifications.

Requirements

• Doctorate degree PhD OR PharmD OR MD [and relevant post-doc where applicable] in Pharmacokinetics or Pharmaceutical Sciences or Pharmacology and 4 years of Clinical Pharmacology, Modeling & Simulation in the Biotechnology/Pharmaceutical Industry.
• Master's degree in Pharmacokinetics or Pharmaceutical Sciences or Pharmacology and 7 years of Clinical Pharmacology, Modeling & Simulation in the Biotechnology/Pharmaceutical Industry
• Bachelor's degree in Pharmacokinetics or Pharmaceutical Sciences or Pharmacology and 9 years of Clinical Pharmacology, Modeling & Simulation in the Biotechnology/Pharmaceutical Industry.

Nice To Haves

• PhD (in Pharmacokinetics or Pharmaceutical Sciences or Pharmacology or equivalent professional degrees e.g. MD, PharmD).
• 4+ years of experience in Clinical Pharmacology, Modeling & Simulation in the Biotechnology/Pharmaceutical Industry.
• Hands-on experience in Quantitative Pharmacokinetic/Pharmacodynamic (PK/PD) approaches with a focus on Population PK/PD modeling, Physiologically Based Pharmacokinetic (PBPK) modeling to inform clinical study designs for drug-drug interaction, special population, ethnic sensitivity, pediatric and biopharmaceutics studies.
• Expert knowledge of commonly used software for PBPK modeling required.
• Experience in leading the design and implementation of clinical pharmacology and biopharmaceutic studies including bioequivalence, bio-comparability, drug-drug interaction, special population, ethnic sensitivity, ADME and pediatric studies and integrating results into regulatory filings, and product labels.
• Established track-record of Model Based Drug Development.
• Established track-record of interaction with global health authorities, authoring regulatory documents, knowledge of global regulatory requirements and guidance.

Responsibilities

• Responsible for the development and implementation of the Clinical Pharmacology and Pharmacometric strategies for cutting-edge innovative therapeutic modalities including Bi-specific T-cell engagers, Bi-specific antibodies, oncolytic viruses, antibody-drug-conjugates as well as traditional small molecules, mono-clonal antibodies and therapeutic peptides.
• Apply innovative Quantitative Pharmacokinetic/Pharmacodynamic (PK/PD) approaches and clinical pharmacology strategies and principles to guide optimal drug development.
• Apply Model-Based Drug Development and principles of quantitative clinical pharmacology to ensure optimal drug development and will represent the Clinical Pharmacology, Modeling & Simulation Department at the global drug development teams.
• Application of Population PK/PD modeling, Physiologically Based Pharmacokinetic (PBPK) modeling, Mechanistic PK/PD modeling and Quantitative Systems Pharmacology (QSP) modeling to new drug development and you will ensure development of safe & effective dosing regimens for various patient sub-populations & also to ensure optimal new drug development.

Benefits

• health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities
• 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 where possible

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Education Level: Ph.D. or professional degree
• Number of Employees: 5,001-10,000 employees