Career Category

Job Description

Title: Senior Associate Development Operations, 12-month contract

Reports to: Senior Manager, Development Operations

Location: Mississauga

Req#: R-90851

JOB SUMMARY

Internal candidates, please discuss your intent to apply with your current manager.  A concurrent external search is being conducted.

Amgen is one of the worlds’ leading biotechnology companies.  Amgen is a values-based organization, deeply rooted in science and innovation to transform new ideas and discoveries into medicines for patients with serious illnesses.

Our culture is what makes Amgen a special place to work. We respect one another, recognize contributions, and have embedded collaboration, trust, empowerment and inclusion in all that we do. Take a few minutes to hear what some of our current staff members are sharing about working at Amgen. Click HERE

Job Purpose:

Supports clinical site management activities by managing all site-related clinical contract and budget negotiations for Amgen Sponsored Trials (ASTs) and Non-Amgen Sponsored Clinical Research (NASCR).

Support the Amgen specific operational activities related to implementation support of Non-Amgen Sponsored Clinical Research (NASCR), which includes Investigator Sponsored Studies (ISS) and Expanded Access Program (EAP).

Key Job Functions:

• Manages the clinical site contracting process, including contract and amendment preparation, negotiation, escalation, tracking and execution for ASTs and NASCRs.

• Participates in appropriate clinical site/legal meetings as required to resolve contract issues.

• Leads the review of the site budget template with the Regional Clinical Trial Manager for country feedback on FMV (Fair Market Value).

• Negotiates site study budget from the base budget and payment milestones using appropriate guidelines.

• Escalates contract and budget issues to Legal, Pricing Group, and/or Regional Clinical Trial Manager as appropriate.

• Configures site contracts and study specific requirements into eClinical payment portal.
• Manages internal stakeholder needs and expectations through regular communication regarding progress and status of pending contract and payment requests.

• Actively contributes to results-oriented global and local departmental goals.

• Identifies opportunities and best practices with local and regional partners that will contribute to overall operational effectiveness.

• Ensures ISSs are supported in accordance with global SOP and other supporting documentation.

• Partners with TA/Medical staff to ensure timely and appropriate support of NASCR deliverables.

• Participates in set-up activities and sponsor support to the SOP.

• Partner with Global /Regional Operations representative regarding drug forecasting including ancillary supplies, clinical trial labeling activities, expiry dates/memos as appropriate.

• Support the collection of ISS Approval Package (ISSAP) documents and forward for signature approval.

• Enter data (including milestone tracking and enrollment status) into and maintain source systems.

• Track essential documentation and archive in EPIC.

Basic Qualifications

BS or MS degree

Preferred Qualifications

• 3+ years experience in contracting, finance administration, project management, or other experience in life sciences or medical field
• Work experience in clinical research obtained working on clinical trials in a biotech, pharmaceutical or CRO
• Knowledge of clinical site contracting processes

Competencies

• Ability to work independently with little supervision as well as in a team environment
• Strong Negotiation skills
• Strong analytical and presentation skills
• Excellent written and oral communication skills
• Attention to detail
• Persistent, tactful and persuasive
• Proficiency with computer/database systems
• Strong organizational skills with the ability to manage multiple priorities
• Knowledge of relevant therapeutic or product area

Amgen endeavors to make its recruitment process accessible to any and all users. Reasonable accommodations will be provided, upon request, to applicants with disabilities in order to facilitate equal opportunity throughout the recruitment and selection process. Please contact TalentAcquisitionInquiries@amgen.com to make a request and ensure you include the requisition number.

Reasonable accommodations are available, upon request, to facilitate the equal participation of candidates with disabilities, should you be selected for an interview.

Join Us

If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen.

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses.

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 but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients.