Clinical Research Medical Director - Oncology - Solid Tumor (Open to remote)
Amgen
2021-10-15T16:40:01Z
Kansas City
Missouri
United States
Healthcare - Allied Health
(No Timezone Provided)
HOW MIGHT YOU DEFY IMAGINATION?
If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Join us.
Clinical Research Medical Director – Oncology
Live
What you will do
Let’s do this. Let’s change the world. Amgen’s Global Development team is looking for a Clinical Research Medical Director within Oncology in Thousand Oaks, CA.
Today, Amgen is advancing the largest early Oncology pipeline in our history spanning several innovative technology platforms – Bispecific T Cell Engagers (BiTE®s), CAR Ts, Bispecific Antibodies, Oncolytic Viruses, Neoantigen Vaccine and Small Molecules – across many targets and more than a dozen tumor types.
In this vital role the Clinical Research Medical Director – Oncology will contribute to the development of overall program clinical development strategy, evidence generation plan (EGP), and execution of program level activities; lead the design and development of clinical study protocols; and serve as a member of the Clinical Study Team – Leadership Team (CST-LT) to provide strategic oversite and execution of clinical trials.
Responsibilities include:
Provide medical and scientific leadership for design of clinical studies (traditional & innovative) and contribute to trial execution from Phase 2 through life cycle management
Collaborate with internal stakeholders and external scientific community such as investigators, key opinion leaders (KOL), etc., as it relates to clinical study design, execution, and results communication. Lead development of and co-author clinical study protocol and related documents for example Key Design Elements (KDE), Clinical Study Reports (CSR), and clinical scientific publications (CSP). Serve as a member of the CST-LT, provide medical and strategic oversight to the study execution. Monitor, analyze, and interpret clinical study data As a Global Development Representative
Responsible for development of Clinical Development Plan for Ph2 and beyond Contribute to TPP and GPS development Contribute to discussions and decision on long-cycle time activities (AC in Ph2, PRO, device, patient voice, TDM, companion diagnostics) Create development options and present to GDRC, FSC Interface with TA leadership and extended team to develop options Interface with CfDA, CfOR, CPMS, etc to bring innovative later dev options Contribute to the development of overall program clinical strategy, EGP, and program level activities
Identify and evaluate new clinical research opportunities Contribute to the development of program clinical development strategy and lifecycle management strategies Participate in interactions with regulatory agencies Provide clinical contribution to regulatory submissions, safety documents, and reimbursement related documents Develop KOL network and make scientific presentation at advisory boards, key scientific meetings and external committee meetings as delegated by Global Development Leader (GDL) Support review of Investigator Sponsored Studies (ISS) proposals Provide support to regional and local Amgen sponsored clinical studies, as necessary Support due diligence for business development activities
Represent Global Development TA to review available confidential clinical data for a given asset/program In partnership with Commercial and Business Development, champion generation of TPPs (target product profiles) for assets/program under review Propose GANTT clinical development timelines
Win
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The medical professional we seek is an excellent communicator with these qualifications.
Basic qualifications:
MD degree from an accredited medical school OR PhD AND completion of an accredited medical or surgical residency OR clinical experience in either an accredited academic setting or private practice (including hospital based) setting Preferred qualifications:
MD or Ph.D plus accredited residency in relevant sub-specialty, board certified or equivalent Thoracic oncology experience preferred Eight (8) or more years of clinical research experience and/or basic science research combined with clinical teaching and patient care activities Clinical research experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO company) Previous management experience Preferred knowledge:
In-depth understanding of the scientific method and clinical applications based on medical, scientific and practical rationale In-depth understanding of and proven success in how to conceptualize, design, and conduct complex, global clinical trials Medical knowledge in the relevant therapeutic area Sound scientific and clinical judgment Understanding of regulatory agency organization, guidelines, and practices and ability to negotiate with these groups Knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and applicable international regulatory requirements Understanding of new drug commercialization and business practices Understanding of resourcing and budgeting
Thrive
What you can expect of us
As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being.
Vast opportunities to learn and move up and across our global organization Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
Apply now for a career that defies imagination
In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us. careers.amgen.com
Equal Opportunity Statement
Clinical Research Medical Director - Oncology - Solid Tumor (Open to remote)
Healthcare - Allied Health
HOW MIGHT YOU DEFY IMAGINATION?
If you feel like you’re part of something bigger, it’s because you are. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies. We are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of. Join us.
Clinical Research Medical Director – Oncology
Live
What you will do
Let’s do this. Let’s change the world. Amgen’s Global Development team is looking for a Clinical Research Medical Director within Oncology in Thousand Oaks, CA.
Today, Amgen is advancing the largest early Oncology pipeline in our history spanning several innovative technology platforms – Bispecific T Cell Engagers (BiTE®s), CAR Ts, Bispecific Antibodies, Oncolytic Viruses, Neoantigen Vaccine and Small Molecules – across many targets and more than a dozen tumor types.
In this vital role the Clinical Research Medical Director – Oncology will contribute to the development of overall program clinical development strategy, evidence generation plan (EGP), and execution of program level activities; lead the design and development of clinical study protocols; and serve as a member of the Clinical Study Team – Leadership Team (CST-LT) to provide strategic oversite and execution of clinical trials.
Responsibilities include:
Provide medical and scientific leadership for design of clinical studies (traditional & innovative) and contribute to trial execution from Phase 2 through life cycle management
Collaborate with internal stakeholders and external scientific community such as investigators, key opinion leaders (KOL), etc., as it relates to clinical study design, execution, and results communication. Lead development of and co-author clinical study protocol and related documents for example Key Design Elements (KDE), Clinical Study Reports (CSR), and clinical scientific publications (CSP). Serve as a member of the CST-LT, provide medical and strategic oversight to the study execution. Monitor, analyze, and interpret clinical study data As a Global Development Representative
Responsible for development of Clinical Development Plan for Ph2 and beyond Contribute to TPP and GPS development Contribute to discussions and decision on long-cycle time activities (AC in Ph2, PRO, device, patient voice, TDM, companion diagnostics) Create development options and present to GDRC, FSC Interface with TA leadership and extended team to develop options Interface with CfDA, CfOR, CPMS, etc to bring innovative later dev options Contribute to the development of overall program clinical strategy, EGP, and program level activities
Identify and evaluate new clinical research opportunities Contribute to the development of program clinical development strategy and lifecycle management strategies Participate in interactions with regulatory agencies Provide clinical contribution to regulatory submissions, safety documents, and reimbursement related documents Develop KOL network and make scientific presentation at advisory boards, key scientific meetings and external committee meetings as delegated by Global Development Leader (GDL) Support review of Investigator Sponsored Studies (ISS) proposals Provide support to regional and local Amgen sponsored clinical studies, as necessary Support due diligence for business development activities
Represent Global Development TA to review available confidential clinical data for a given asset/program In partnership with Commercial and Business Development, champion generation of TPPs (target product profiles) for assets/program under review Propose GANTT clinical development timelines
Win
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The medical professional we seek is an excellent communicator with these qualifications.
Basic qualifications:
MD degree from an accredited medical school OR PhD AND completion of an accredited medical or surgical residency OR clinical experience in either an accredited academic setting or private practice (including hospital based) setting Preferred qualifications:
MD or Ph.D plus accredited residency in relevant sub-specialty, board certified or equivalent Thoracic oncology experience preferred Eight (8) or more years of clinical research experience and/or basic science research combined with clinical teaching and patient care activities Clinical research experience in the biopharmaceutical industry (biotech, pharmaceutical or CRO company) Previous management experience Preferred knowledge:
In-depth understanding of the scientific method and clinical applications based on medical, scientific and practical rationale In-depth understanding of and proven success in how to conceptualize, design, and conduct complex, global clinical trials Medical knowledge in the relevant therapeutic area Sound scientific and clinical judgment Understanding of regulatory agency organization, guidelines, and practices and ability to negotiate with these groups Knowledge of Good Clinical Practices (GCP), FDA regulations and guidelines, and applicable international regulatory requirements Understanding of new drug commercialization and business practices Understanding of resourcing and budgeting
Thrive
What you can expect of us
As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being.
Vast opportunities to learn and move up and across our global organization Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
Apply now for a career that defies imagination
In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us. careers.amgen.com
Equal Opportunity Statement