Biosimilar Study Manager

Thousand Oaks, CA, USA

Full-TimeDepends on ExperienceSenior LevelMasters

Job Description

Amgen is seeking a highly motivated and experienced Biosimilar Study Manager to join our dynamic and innovative team. In this role, you will have the opportunity to lead and drive the development of biosimilar products, contributing to the advancement of medical science and improving patient lives. We are looking for a passionate individual with a strong background in biosimilar development and a proven track record of successfully managing complex studies. If you are a self-starter with excellent organizational skills and a strong attention to detail, we encourage you to apply for this exciting opportunity at Amgen.

Lead and drive the development of biosimilar products, contributing to the advancement of medical science and improving patient lives.
Manage and oversee complex studies related to biosimilar development.
Develop and implement study plans, timelines, and budgets.
Coordinate and collaborate with cross-functional teams, including clinical, regulatory, and commercial teams, to ensure successful execution of biosimilar studies.
Identify and address any potential study risks and develop mitigation plans.
Monitor and track study progress and provide regular updates to senior management.
Manage study vendors and ensure their compliance with study protocols and regulations.
Ensure all study activities are conducted in accordance with Good Clinical Practice (GCP) guidelines and regulatory requirements.
Review and analyze study data, and ensure accurate and timely reporting.
Act as a point of contact for study-related inquiries and provide support to study team members.
Stay up-to-date with industry developments and regulatory requirements related to biosimilar development.
Mentor and provide guidance to junior study team members.
Contribute to the development and improvement of biosimilar development processes and procedures.
Represent Amgen at scientific conferences and meetings, as needed.
Demonstrate a strong commitment to ethical conduct and compliance with company policies and procedures.

Where is this job?

This job is located at Thousand Oaks, CA, USA

Job Qualifications

Bachelor's Degree In A Relevant Scientific Field, Such As Biology, Biochemistry, Or Pharmaceutical Sciences.
Minimum Of 5 Years Experience In Clinical Research, Preferably In The Biotechnology Or Pharmaceutical Industry.
Strong Understanding Of The Regulatory Landscape And Requirements For Biosimilar Development.
Demonstrated Project Management Skills, With Experience Leading Cross-Functional Teams And Managing Timelines And Budgets.
Excellent Communication And Interpersonal Skills, With The Ability To Effectively Collaborate With Internal And External Stakeholders.

Required Skills

Risk Management
Project Management
Data Analysis
Communication
Budget management
Quality Control
Team Leadership
Regulatory compliance
Stakeholder management
Clinical Trials
Protocol Development
Pharmaceutical Industry

Soft Skills

Communication
Conflict Resolution
Emotional Intelligence
Leadership
Time management
creativity
Teamwork
Adaptability
Problem-Solving
Decision-making

Compensation

According to JobzMall, the average salary range for a Biosimilar Study Manager in Thousand Oaks, CA, USA is $100,000 - $120,000 per year.

Additional Information

Amgen is an Equal Opportunity Employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We do not discriminate based upon race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.

Required LanguagesEnglish

Job PostedDecember 19th, 2023

Apply BeforeAugust 19th, 2025

This job posting is from a verified source.

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