Medical Sciences Director - Late Development, Thoracic Oncology

7+ years

Not Disclosed

Remote, USA

10 Nov. 26, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Posting Title: Medical Sciences Director - Late Development Oncology

Career Category: Medical Sciences
Employee Subgroup: Salaried FT
Location: Hybrid - Based out of either Cambridge, Massachusetts, West Greenwich, Rhode Island, or Holly Springs, North Carolina
Country/Region: U.S.

Amgen Job Description

Let’s do this. Let’s change the world! At Amgen, we are advancing the largest Oncology pipeline in our history, featuring several innovative technology platforms such as Bispecific T Cell Engagers (BiTE®s), Bispecific Antibodies, and Small Molecules, targeting more than a dozen tumor types. To help bring these promising therapies to patients, we need collaborative and innovative world-class talent to drive late-phase clinical development.

Amgen’s Oncology Late Development Group is looking for a Medical Sciences Director to contribute to the successful progression of our oncology pipeline. The successful candidate will collaborate across teams to define, design, and deliver late-phase clinical results, while contributing to translational projects that shape Amgen’s drug development strategies. As a Medical Director, you will provide subject matter expertise in clinical and translational trial science, oncology biology, and cancer treatments, offering intellectual insight into experimental design and data analysis.

What You Will Do:

Serve as an internal clinical expert in translational and clinical oncology.
Support the medical monitor in clinical trials, addressing issues as they arise.
Present key data internally and externally, proactively managing challenges across cross-functional teams.
Guide the identification and management of oncology collaborators, consultants, and CROs for key projects.
Collaborate to translate clinical strategy into study concepts, protocols, and related documents.
Ensure the integrity of protocols, facilitating governance approval processes.
Provide clinical input for the implementation of clinical trials, data review, and the interpretation of results.
Conduct data quality assessments, ensuring accuracy, completeness, and adherence to protocols and regulatory requirements.

What We Expect of You:

We are looking for a dynamic leader who brings the following qualifications:

Basic 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

Preferred Qualifications:

5+ years of experience in pharmaceutical clinical drug development.
Strong preference for a proven track record in thoracic oncology clinical trial process improvement.
Industry or academic experience in late-phase oncology drug development.
Strong communication and presentation skills to clearly articulate scientific concepts and data to leadership teams (internally and externally).
Experience designing, monitoring, and implementing oncology clinical trials, interpreting test results in compliance with Good Clinical Practice and regulatory requirements.
Familiarity with conducting study data readout activities, including data cleaning, database locking, and data extraction.
Expertise in drafting high-level submission documents for regulatory submissions, including clinical regulatory responses for health regulatory interactions.
Contributing author to scientific publications and data presentations at scientific conferences.
Experience in clinical data analysis using tools such as Spotfire or other data analysis platforms.

What You Can Expect From Us:

At Amgen, we support your growth and well-being, both professionally and personally. We offer competitive benefits, a collaborative culture, and the opportunity to make a profound impact on patients’ lives. With our Total Rewards Plan, we provide:

A comprehensive employee benefits package including Retirement and Savings Plans, group medical, dental, and vision coverage, life and disability insurance, and flexible spending accounts.
A discretionary annual bonus program, or a sales-based incentive plan for field sales representatives.
Stock-based long-term incentives.
Award-winning time-off plans.
Flexible work models, including remote and hybrid work arrangements where possible.

Apply Now

Join us to be part of a career that defies imagination. Together, we will make a lasting impact on patients’ lives.

[Apply Here]

Equal Opportunity Statement:

Amgen is an Equal Opportunity Employer and will consider all qualified applicants regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability status, or any other protected basis. We ensure reasonable accommodations for individuals with disabilities to participate in the job application process, perform essential job functions, and enjoy the benefits of employment. Please contact us to request accommodation.

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