Senior Manager - Research & Development Operations (Biospecimen Strategy and Operations)

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

Career Category

Project Management

Job Description

Responsibilities

·Provide leadership across Data Ops, Quality, Logistics, Project Coordination and supporting teams in India.·Manage and develop staff and their teams of analysts and specialists in collaboration with US-based strategic leaders·Align with global hubs for 24-hour operational coverage.·Monitor SLA performance, portfolio delivery, and audit readiness.·Drive process standardization, automation, and efficiency.·Oversee staffing, career development, and capacity planning.·Act as primary escalation point for operational or compliance issues.·Oversee daily work guided by operational objectives and management influence such as:•Oversight and management of suppliers, including business continuity•Oversight of results management and provision 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

ŸDoctorate degree and 2 years of industry related experience

OR

ŸMaster’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..

Experience Level

Senior Level