Sr. Manager, R&D Operations - Biospecimen Strategy and Operations

vision to data management

• Oversight and process improvement of receiving, storing and tracking clinical and preclinical samples for Amgen's worldwide trials

• Supplier governance activities

• Audit and inspection activities

• Oversight of deviation and compliance remediation

• Providing resources for problem solving and issue resolution

• Oversee facilitation of discrepancy resolution of sample metadata and visit codes

• Provide input as expert/liaison for clinical operations capabilities, e.g. trial experience

• Serve as escalation point and issue remediation for personnel performance expectations.

Ensure appropriate escalation for issues outside of individual performance expectations

Qualifications

The knowledge and skills necessary to perform the duties of this position are typically acquired through the following combination of education, experience and knowledge, or the equivalent.

Minimum Requirements

Doctorate degree and 2 years of industry related experience

OR

Master's degree & 6 years of management related experience

OR

• Bachelor's degree & 8 years of management related experience

AND

• Strong project management experieice

• Scientific technical expertise of specific function and/or business process/category

Preferred Requirements

• 9+ years work experience in life sciences field, including 6 years of biopharmaceutical R&D experience

• Knowledge and functional expertise in R&D, with strong experience in at least one of the following areas: data management, biospecimen management, global logistics, project management, regulatory submission requirements and inspection management

• Knowledge of GLP, GCP and global guidelines for nonclinical studies and regulatory document requirements for Investigational New Drug (IND) filings

• Evidence of strong project management skills

• Exceptional verbal and written communication skills, including scientific technical writing

• Exceptional knowledge of document management applications and study planning tools (eg.Planisware, SmartSheet, Tableau, Veeva platform, etc)

• Excellent interpersonal, organizational, and critical thinking skills

Competencies

• Scientific technical expertise in Research and Clinical trials specialty area

• Process expert

• Project and people management

• Process management and planning skills

• Leadership and strategy

• Conflict management

• Visionary people leadership and mentoring ability.

• Strong stakeholder influence across geographies.

• Critical thinking

• Learning agility

• Financial acumen

• Knowledge of R&D thru commercialization

• Capable of creative problem solving

• Ability to envision and implement business process solutions

• Excellent organization skills

• Excellent written and verbal communication skills

• Strong presentation skills

• Collaborates, negotiates and persuades others, both internally and externally; with attention to managing across time zones

• Demonstrates a strong customer focus in all activities

• Analyses complex problems; integrates disciplinary and business strategy knowledge to develop recommendations

• Openly promotes cooperation across the organization

• Project and issue management skills

• Drives for results; delivers processes and outcomes of the highest quality

• Consistently communicates in a manner that is appropriate to the situation

• High accountability, adaptability, and integrity.

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