Amgen

Global Early Clinical Development Manager - Early Development

Employer
Amgen
Location
Thousand Oaks, CA, US
Posted
Jul 22, 2019
Ref
R-73417
Required Education
High School or equivalent
Position Type
Full time
Few careers offer the chance to make a difference in people's lives. Take advantage of the opportunity at Amgen, the world's largest biotechnology company. With global manufacturing operations and clinical development sites on three continents, Amgen is focused and committed to making our products available to improve patients' lives through innovative science.

Amgen Early Clinical Development is looking for a Global Early Clinical Development Manager (GECDM) to be accountable for the execution, management and reporting of early development clinical trials. The GECDM is a member of one or more cross-functional clinical study teams and a core member of the Evidence Generating Team. These complex programs focus on the rapid development of emerging New Molecular Entities (NMEs) with limited clinical data, and as such, require implementation of novel and highly flexible global operational strategies to support exploratory hypotheses, patient populations including biomarkers and diagnostics. A GECDM collaborates amongst peers and Evidence Generating Team members.

The Global Early Clinical Development Manager will work in varying therapeutic areas including oncology, cardiovascular, inflammation, neuroscience and healthy volunteer.

Responsibilities:
  • Lead the Program level planning of the overall operational deliverables at the Evidence Generation Team meetings
  • Develop the strategic scenarios on the designs of the clinical development plan as part of the EGP development
  • Drive the Operational Strategy of the Molecule
  • Contribute to the development of the clinical protocol and are the authors of the protocol
  • Contribute to the writing and review of study related documentation, including safety and regulatory documents, Clinical Study Report and publications
  • Responsible for generating and overseeing the study budgets and timelines and updating systems to changes of the assumptions
  • Responsible for the ongoing evaluation of the feasibility of the program strategy and amending study timelines, as appropriate.
  • Identify, and perform feasibility for the selection of early phase clinical investigators
  • Help organize and assist in investigator and site meetings, initiating early engagement with key thought leaders
  • Responsible for ensuring all site and study team members receive adequate training to conduct early development studies
  • Drive the oversight of the preparation of site initiation regulatory documents, approve site visit report and provide overall management of study related activities
  • Lead the coordination of the Dose Level Review meetings, communicates


Basic Qualifications:

Doctorate Degree

OR

Master's Degree and 3 years of Clinical experience

OR

Bachelor's Degree and 5 years of Clinical experience

OR

Associate's degree and 10 years of Clinical experience

OR

High school diploma/GED and 12 years of Clinical experience

Preferred Qualifications:

MS, RN, or PharmD Degree

7+ years of experience in life sciences or medically related field

4+ years of bio-pharmaceutical clinical research experience obtained working on industry-sponsored or industry-partnered clinical trials at academic institutions or working on clinical trials in a biotech, pharmaceutical or CRO company

Management experience of direct reports

Experience in oversight of Functional Service Providers, outside vendors (CRO's, central labs, imaging vendors, etc)