Clinical Sciences Director, Oncology

1001 Amgen Inc.; Thousand Oaks (CA); Híbrido; USD 211 000 - 286 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Retirement plan

Medical/dental/vision coverage

Life & disability insurance

Flexible spending accounts

Annual bonus program

Stock-based long-term incentives

Generous time-off plans

Flexible work models (remote & hybrid)

Resumo da oferta

Amgen Inc. is seeking a Clinical Sciences Director - Oncology to lead late-phase investigations and translational efforts in cancer drug development.

You will partner with cross-functional teams to shape study concepts, protocols, and regulatory interactions. You will bring a strong track record in oncology clinical trials, data interpretation, and scientific leadership, enabling robust decision-making and strategic execution across programs.

Qualificações

• 5+ years in pharmaceutical clinical drug development
• Proven track record in oncology trial process improvement
• Experience in late-phase oncology drug development
• Experience drafting regulatory submissions and responses
• Experience in clinical data analysis

Responsabilidades

• Define, design and deliver late phase clinical results, plus translational projects for ongoing drug development strategy
• Provide subject matter expertise in clinical trial science and oncology biology/treatment
• Contribute intellectual insight into experimental design and data analysis
• Serve as internal clinical expert in translational and clinical oncology
• Support medical monitor in trials and assist in issue resolution
• Present information internally and externally, managing cross-functional stakeholders across teams
• Identify and manage oncology collaborators/CROs for key projects
• Translate clinical strategy into study concept documents and protocols
• Ensure protocol integrity and governance for final approvals
• Provide clinical input into trial delivery, data review and regulatory interpretation
• Review data for accuracy, completeness and adherence to protocol

Conhecimentos

Leadership in oncology trials

Clinical trial design & oversight

Data analysis (Spotfire or similar)

Regulatory submission experience

Communication & presentation skills

Cross-functional collaboration

Oncology pharmacology knowledge

Formação académica

Doctorate degree

Master's degree

Bachelor's degree

Ferramentas

Spotfire

Descrição da oferta de emprego

Career Category Clinical Development Job Description

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.

Clinical Sciences Director - Oncology

What you will do

Let's do this. Let's change the world.

• They will collaborate on teams to define, design, and deliver late phase clinical results, supplemented by translational projects in the ongoing strategy for drug development.
• The Medical Director provides subject matter expertise in clinical and translational trial science as well as the biology and treatment of cancer.
• They will contribute intellectual insight into experimental design and data analysis.
• Serve as an internal clinical expert in translational and clinical oncology
• Support medical monitor in clinical trials and assist in resolving issues that may arise
• Present information internally and externally, anticipating and actively managing problems across a broad spectrum of cross-functional teams
• Provide guidance and assistance in the identification and management of oncology collaborators, consultants, and/or Clinical Research Organizations (CROs) in completion of key projects
• Work cross functionally to ensure clinical strategy is translated into the development of the study concept document, study protocol and related documents.
• Ensure integrity of protocols and/or components of clinical plans and for the delivery of final protocol and its governance approval.
• Provide clinical input into & implementation of clinical trial(s), their delivery, clinical data review, interpretation of results.
• Review and analyze clinical trial data to ensure accuracy, completeness and adherence to protocol and regulatory requirements
• Conduct thorough data quality assessments in the context of a data monitoring plan to maintain high standards of data accuracy and integrity throughout the trial lifecycle

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.

• Doctorate degree and 4 years of life sciences/healthcare experience OR Master's degree and 7 years of life sciences/healthcare experience OR Bachelor's degree and 9 years of life sciences/healthcare experience
• 5 years of pharmaceutical clinical drug development experience
  Strong preference for individuals with proven track record of oncology clinical trial process improvement
  Industry or academic experience in late-phase oncology drug development
  Strong communication & presentation skills to clearly communicate scientific concepts /data to leadership committees both internally or externally (both written and oral)
  Experience with designing, monitoring, and implementing oncology clinical trials and interpreting test results in compliance with Good Clinical Practice standards and regulatory requirements
  Understanding of conducting study data readout activities, including data cleaning, data base lock, data extract, producing outputs of data
  Experience drafting high level submission documents for regulatory submissions including authoring clinical regulatory responses for health regulatory interactions
  Serving as a contributing author to scientific publications and data presentations at scientific conferences
  Experience in clinical data analysis such as Spotfire or other data analysis tools

What you can expect of us

From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.

• 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

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications. In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of 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 that may include: 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

In any materials you submit, you may redact or remove age-identifying information such as age, date of birth, or dates of school attendance or graduation. You will not be penalized for redacting or removing this information.

Application deadline Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

Sponsorship

Sponsorship for this role is not guaranteed. 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 and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. 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, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Salary Range 211,176.55USD -285,709.45 USD

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 biologics manufacturing 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.

For more information, visit www.amgen.com and follow us on www.twitter.com/amgen