25 days old

Medical Director - Global Development Leader - Oncology

Amgen
Thousand Oaks, CA 91360
  • Job Code
    118953706
Amgen

Job ID: R-95665
Location: Thousand Oaks, CA, US 91360

The Global Clinical Development therapeutic area is looking for a strong leader in Hematology/Oncology. This Medical Director, Global Development Leader, will lead phase II-III clinical development of oncology compounds.

They define, design, and execute clinical development as a strategy for drug development. They typically serve as project leaders for one or more of Amgen's Product Strategy Teams through their role as a Clinical Research Medical Director. These experts represent Medical Sciences internally and externally, contributing intellectual insight into experimental design and data analysis. They provide subject matter expertise in clinical and translational trial science as well as the biology and treatment of cancer.

Responsibilities:
  • Support the development and execution for clinical trials and be the medical science expert in resolving significant issues that may affect the studies.
  • Provide the strategy and execution of communication, presenting information internally and externally, anticipating and proactively managing problems across a broad spectrum of cross-functional teams.
  • Ensure clinical approaches to operational issues and approve monitoring and safety-reporting resource plans.
  • Author CSRs, publications and regulatory submissions.
  • Support the development and execution of the trial portfolio including the identification and management of oncology phase 2-3 collaborators, consultants, and/or Clinical Research Organizations (CROs) in completion of key projects.
  • Ensure appropriate programs within training, recruitment, and development requirements for matrix team resources
  • Support cross-functional and global collaborations to integrate broad medical, scientific, and commercial input into the development program
  • Develop and interface with industry key opinion leaders and manage scientific presentation at advisory boards, key scientific meetings and external committee meetings
  • Be the primary Medical Sciences contact for scientists studying hematologic and solid tumor malignancies as well as for clinical research scientists overseeing early and later clinical development.
  • Develop a strategy for product growth by evaluating and identifying external opportunities for partnering or licensing new oncology assets
  • Support the Global Brand Team in the brand planning process to ensure alignment between medical and brand activities, and help providing interpretation of clinical study data


Basic Qualifications

MD or DO degree from an accredited medical school

AND

5 years of either industry or academic research experience

AND

Previous management experience

Preferred Qualifications
  • Subspecialty board eligibility/certification in Oncology and/or Hematology
  • Strong basic science or clinical research background in academia or industry
  • Prior experience authoring, monitoring, analyzing, and presenting oncology clinical trials
  • Effective presentation and communication abilities (both written and oral)
  • In-depth understanding of the scientific method and clinical applications based on medical, scientific and practical rationale including working knowledge of biomarker methods and clinical imaging endpoints
  • A record of high-quality peer-reviewed publications
  • Experience functioning as a medical expert in a complex matrixed environment
  • Previous experience in late stage oncology clinical trials and regulatory filings
  • Knowledge of GCP, EMA, and FDA policies
  • Expertise in authoring clinical sections of CTA or INDs


Our recruitment strategy includes fostering diverse points of view - helping to drive innovation and creativity.

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.

MD01

#LI-POST

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.

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.

PI118953706

<b>Amgen</b><br/><br/><b>Job ID: </b>R-95665<br/><b>Location: </b>Thousand Oaks, CA, US 91360<br/><br/>The Global Clinical Development therapeutic area is looking for a strong leader in Hematology/Oncology. This Medical Director, Global Development Leader, will lead phase II-III clinical development of oncology compounds.<br><br>They define, design, and execute clinical development as a strategy for drug development. They typically serve as project leaders for one or more of Amgen's Product Strategy Teams through their role as a Clinical Research Medical Director. These experts represent Medical Sciences internally and externally, contributing intellectual insight into experimental design and data analysis. They provide subject matter expertise in clinical and translational trial science as well as the biology and treatment of cancer.<br><br>Responsibilities:<br><ul><li>Support the development and execution for clinical trials and be the medical science expert in resolving significant issues that may affect the studies.</li><li>Provide the strategy and execution of communication, presenting information internally and externally, anticipating and proactively managing problems across a broad spectrum of cross-functional teams.</li><li>Ensure clinical approaches to operational issues and approve monitoring and safety-reporting resource plans.</li><li>Author CSRs, publications and regulatory submissions.</li><li>Support the development and execution of the trial portfolio including the identification and management of oncology phase 2-3 collaborators, consultants, and/or Clinical Research Organizations (CROs) in completion of key projects.</li><li>Ensure appropriate programs within training, recruitment, and development requirements for matrix team resources</li><li>Support cross-functional and global collaborations to integrate broad medical, scientific, and commercial input into the development program</li><li>Develop and interface with industry key opinion leaders and manage scientific presentation at advisory boards, key scientific meetings and external committee meetings</li><li>Be the primary Medical Sciences contact for scientists studying hematologic and solid tumor malignancies as well as for clinical research scientists overseeing early and later clinical development.</li><li>Develop a strategy for product growth by evaluating and identifying external opportunities for partnering or licensing new oncology assets</li><li>Support the Global Brand Team in the brand planning process to ensure alignment between medical and brand activities, and help providing interpretation of clinical study data</li></ul><br><br><b>Basic Qualifications </b><br><br>MD or DO degree from an accredited medical school<br><br>AND<br><br>5 years of either industry or academic research experience<br><br>AND<br><br>Previous management experience<br><br><b>Preferred Qualifications </b><br><ul><li>Subspecialty board eligibility/certification in Oncology and/or Hematology</li><li>Strong basic science or clinical research background in academia or industry</li><li>Prior experience authoring, monitoring, analyzing, and presenting oncology clinical trials</li><li>Effective presentation and communication abilities (both written and oral)</li><li>In-depth understanding of the scientific method and clinical applications based on medical, scientific and practical rationale including working knowledge of biomarker methods and clinical imaging endpoints</li><li>A record of high-quality peer-reviewed publications</li><li>Experience functioning as a medical expert in a complex matrixed environment</li><li>Previous experience in late stage oncology clinical trials and regulatory filings</li><li>Knowledge of GCP, EMA, and FDA policies</li><li>Expertise in authoring clinical sections of CTA or INDs</li></ul><br><br>Our recruitment strategy includes fostering diverse points of view - helping to drive innovation and creativity.<br><br>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.<br><br>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.<br><br>MD01<br><br>#LI-POST<br><br>Join Us <br> <br> If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. <br> <br> Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. <br> <br> As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. <br> <br> 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.<br/><br/> <img src="https://analytics.click2apply.net/v/KMdjR5tLGWaxUpG7iXwaN"> <p>PI118953706</p>

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Posted: 2020-03-12 Expires: 2020-04-12

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Medical Director - Global Development Leader - Oncology

Amgen
Thousand Oaks, CA 91360

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