Manager, Investigator Initiated and Expanded Access Programs

BeiGene, Ltd.; United States; Remote; USD 130,000 - 170,000; Full time

Job summary

An innovative global oncology company is seeking an experienced Manager for Investigator Initiated and Expanded Access Programs. This remote role offers the chance to lead and manage critical programs that adhere to FDA regulations and Good Clinical Practice guidelines. The ideal candidate will possess strong project management skills and a collaborative spirit, working across multiple teams to ensure successful program implementation. Join a passionate team dedicated to improving access to life-saving cancer treatments and enjoy a comprehensive benefits package that supports your well-being and professional growth.

Benefits

Medical Insurance

Dental Insurance

Vision Insurance

401(k)

Paid Time Off

Wellness Programs

Equity Awards

Stock Purchase Plans

Qualifications

• 5+ years of experience in clinical research or pharmaceutical industry.
• Strong project management skills and ability to manage multiple projects.

Responsibilities

• Manage all aspects of expanded access programs and IITs.
• Coordinate with various departments for effective program management.

Skills

Project Management

Interpersonal Skills

Data Reporting

Microsoft Office Suite

IIT Tracking Software

Veeva Systems

Education

Bachelor’s Degree

Tools

Microsoft Office Suite

IIT Tracking Software

Veeva Systems

Job description

Manager, Investigator Initiated and Expanded Access Programs

Apply locations: Remote (US)

Time type: Full time

Posted on: Posted 2 Days Ago

Job requisition id: R29102

BeiGene, Ltd. has proposed to change its name to BeOne Medicines Ltd. The new name is subject to shareholder approval and, once approved, use of the name will be phased in over 2025. During this transition, “BeiGene” or “BeOne” may still be used to describe the company. BeOne continues to grow rapidly, offering challenging and exciting opportunities for experienced professionals. We seek scientific and business professionals who are highly motivated, collaborative, and share our passionate interest in fighting cancer.

General Description:

We have an exciting opportunity for an experienced Investigator-initiated (IIT), post-marketing clinical trials, and Expanded Access Program Manager or Sr. Manager. The candidate will manage all aspects of expanded access programs and IITs, including implementation across multiple institutions and research settings, adhering to FDA regulations and Good Clinical Practice guidelines. This role also involves program management, including using the BGNE contract system for contracts and report creation through the CG portal. This position is remote, with no direct reports.

Essential Functions:

• Support IIT and EAP operations, project management, cross-functional collaboration, process improvement, and vendor management, including tracking IIT KPIs.
• Maintain ongoing EA programs and lead new program implementations.
• Assist with monthly study status reports and update study information in the CG portal.
• Coordinate with the Accounting Department to manage POs, payments, and invoices.
• Collaborate with Quality and Clinical Supply Chain teams as needed.
• Monitor study progress, milestones, and payments.
• Develop strong interpersonal skills for effective communication and relationship building with internal and external stakeholders.
• Communicate complex medical and scientific information effectively.
• Provide operational support to field medical teams regarding trials and activities.
• Position level is commensurate with experience.

Education Required:

• Bachelor’s Degree required.

Qualifications:

• Bachelor’s Degree with 5+ years of overall experience and 1+ years in the pharmaceutical industry, clinical research, consulting, or CRO.
• Experience with Microsoft Office Suite, IIT tracking software, and Veeva systems.
• Ability to create data extracts and reports.
• Strong project management skills.
• Ability to plan, prioritize, and execute multiple projects independently and within multidisciplinary teams.

Travel:

• Approximately 5-10% work-related travel.

Global Competencies:

Our values of Patients First, Driving Excellence, Bold Ingenuity, and Collaborative Spirit are exemplified through twelve global competencies, including fostering teamwork, providing honest feedback, self-awareness, inclusion, initiative, entrepreneurial mindset, continuous learning, embracing change, results orientation, analytical thinking, financial excellence, and clear communication.

Salary Range: $130,000 - $170,000 annually

BeOne is committed to fair and equitable compensation practices. Actual packages depend on skills, experience, education, location, and other factors. Benefits include medical, dental, vision, 401(k), FSA/HSA, life insurance, paid time off, wellness programs, and participation in incentive plans. Employees may also own shares through equity awards and stock purchase plans.

We are an equal opportunity employer, committed to diversity and inclusion, and do not discriminate based on race, religion, gender, age, disability, or other protected categories.

About Us

BeiGene, Ltd. plans to rebrand as BeOne Medicines Ltd., pending shareholder approval, with the transition phased over 2025. During this period, both names may be used.

BeOne is a global oncology company developing affordable, innovative cancer treatments. With a diverse pipeline and collaborations, we aim to improve access to medicines worldwide. Our team of over 11,000 spans six continents. Learn more at www.beigene.com and follow us on LinkedIn, X, Facebook, and Instagram.

For Candidates in Mainland China

Visit the provided link for more information on opportunities in China Mainland.

Our Values

How we work is as important as the work we do, guided by our core values that influence our decisions and actions.