BioSpace
Medical Sciences Director - Late Development, Sotorasib
BioSpace, Washington, District of Columbia, us, 20022
Overview
Medical Sciences Director - Late Development, Sotorasib Join Amgen’s mission of serving patients living with serious illnesses. Since 1980, Amgen has helped pioneer biotech in the fight against the world’s toughest diseases. Our focus areas include Oncology, Inflammation, General Medicine, and Rare Disease.
What You Will Do
You will contribute to late-phase clinical development of oncology. The Medical Science Director will collaborate on teams to define, design, and deliver late-phase clinical results, supplemented by translational projects in the ongoing strategy for drug development. You will provide subject matter expertise in clinical and translational trial science as well as the biology and treatment of cancer. You will support experimental design and clinical data review in late-phase clinical trials. Serve as an internal clinical expert in translational and clinical oncology Collaborate with medical monitor to support clinical trial level activities Present information internally and externally, anticipating and actively managing problems across cross-functional teams Provide guidance in identifying and managing oncology collaborators, consultants, and/or Clinical Research Organizations (CROs) for key projects Work cross-functionally to translate clinical strategy into study concept documents, study protocols, and related documents Ensure integrity of protocols and components of clinical plans and obtain final protocol governance approval Provide clinical input into the implementation of clinical trials, data review, and interpretation of results; review and analyze data for accuracy, completeness, and regulatory compliance Conduct thorough data quality assessments within a data monitoring plan to maintain data accuracy and integrity throughout the trial lifecycle
What We Expect Of You
We seek a leader with the following qualifications: Basic Qualifications
Doctorate degree with 4 years of life sciences/healthcare experience OR Masters degree with 7 years of life sciences/healthcare experience OR Bachelors degree with 9 years of life sciences/healthcare experience
Preferred Qualifications
5 years of pharmaceutical clinical drug development experience Proven track record of oncology clinical trial process improvement Industry or academic experience in late-phase oncology drug development Strong communication and presentation skills for leadership committees (written and oral) Experience designing, monitoring, and implementing oncology clinical trials in accordance with GCP and regulatory requirements Experience with study data readouts, including data cleaning, database lock, data extraction, and data outputs Experience drafting high-level regulatory submission documents and clinical regulatory responses Contributing author to scientific publications and data presentations Experience in clinical data analysis using tools such as Spotfire or similar
What You Can Expect Of Us
We support your professional and personal growth and well-being. From competitive benefits to a collaborative culture, we help you on your journey. The salary is posted as a range and will vary based on factors such as skills, experience, and qualifications. In addition to base salary, Amgen offers a Total Rewards Plan including health and welfare plans, retirement savings, stock-based incentives, time-off programs, and flexible work models where possible. Apply now and make a lasting impact with the Amgen team. Our careers site is careers.amgen.com. We respect privacy and comply with applicable equal employment opportunity laws.
Additional
Amgen is an Equal Opportunity employer and will consider all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by law. We provide reasonable accommodations in the application process upon request.
Job Details
Seniority level: Mid-Senior level Employment type: Full-time Job function: Research, Analyst, and Information Technology Industries: Internet News
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Medical Sciences Director - Late Development, Sotorasib Join Amgen’s mission of serving patients living with serious illnesses. Since 1980, Amgen has helped pioneer biotech in the fight against the world’s toughest diseases. Our focus areas include Oncology, Inflammation, General Medicine, and Rare Disease.
What You Will Do
You will contribute to late-phase clinical development of oncology. The Medical Science Director will collaborate on teams to define, design, and deliver late-phase clinical results, supplemented by translational projects in the ongoing strategy for drug development. You will provide subject matter expertise in clinical and translational trial science as well as the biology and treatment of cancer. You will support experimental design and clinical data review in late-phase clinical trials. Serve as an internal clinical expert in translational and clinical oncology Collaborate with medical monitor to support clinical trial level activities Present information internally and externally, anticipating and actively managing problems across cross-functional teams Provide guidance in identifying and managing oncology collaborators, consultants, and/or Clinical Research Organizations (CROs) for key projects Work cross-functionally to translate clinical strategy into study concept documents, study protocols, and related documents Ensure integrity of protocols and components of clinical plans and obtain final protocol governance approval Provide clinical input into the implementation of clinical trials, data review, and interpretation of results; review and analyze data for accuracy, completeness, and regulatory compliance Conduct thorough data quality assessments within a data monitoring plan to maintain data accuracy and integrity throughout the trial lifecycle
What We Expect Of You
We seek a leader with the following qualifications: Basic Qualifications
Doctorate degree with 4 years of life sciences/healthcare experience OR Masters degree with 7 years of life sciences/healthcare experience OR Bachelors degree with 9 years of life sciences/healthcare experience
Preferred Qualifications
5 years of pharmaceutical clinical drug development experience Proven track record of oncology clinical trial process improvement Industry or academic experience in late-phase oncology drug development Strong communication and presentation skills for leadership committees (written and oral) Experience designing, monitoring, and implementing oncology clinical trials in accordance with GCP and regulatory requirements Experience with study data readouts, including data cleaning, database lock, data extraction, and data outputs Experience drafting high-level regulatory submission documents and clinical regulatory responses Contributing author to scientific publications and data presentations Experience in clinical data analysis using tools such as Spotfire or similar
What You Can Expect Of Us
We support your professional and personal growth and well-being. From competitive benefits to a collaborative culture, we help you on your journey. The salary is posted as a range and will vary based on factors such as skills, experience, and qualifications. In addition to base salary, Amgen offers a Total Rewards Plan including health and welfare plans, retirement savings, stock-based incentives, time-off programs, and flexible work models where possible. Apply now and make a lasting impact with the Amgen team. Our careers site is careers.amgen.com. We respect privacy and comply with applicable equal employment opportunity laws.
Additional
Amgen is an Equal Opportunity employer and will consider all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by law. We provide reasonable accommodations in the application process upon request.
Job Details
Seniority level: Mid-Senior level Employment type: Full-time Job function: Research, Analyst, and Information Technology Industries: Internet News
#J-18808-Ljbffr