Associate Director, Study Operations and Assessment Planning

Summary

The Associate Director, Study Operations and Assessment Planning is accountable for the functional line management of all Study Operations and Assessment Planners in the Clinical Trial and Operational Execution organization as well as providing business leadership for the development of all tools, processes and standards for the Study Operations and Assessment Planning function. Study Operations and Assessment Planners are responsible for aligning protocol assessment tables, assisting with clinical trial designs as it relates to the SOA, streamlining operations throughout multiple BMS internal groups, and managing study level SOAP operational needs for Phase I-IV clinical trials.

Specifically the Associate Director, Study Operations and Assessment Planning is accountable for:

Provides functional leadership for the current Study Operations and Assessment Planners by managing staff performance, development, training, project assignments and workload distribution and supporting issue resolution with direct reports.

Drives innovation through collaboration with Clinical Teams, BIA, Global Clinical Trial Planning & Alliance Management, and other stakeholders as the business owner for Study Operations and Assessment planning tools and related initiatives

Supports the development of study design metrics used to analyze complexity of BMS clinical trials

Demonstrates ability to analyze clinical trial designs as part of a strategy to provide guidance to Global Clinical Operations to optimize trial planning and support operational feasibility

Collaborates with the various functions to develop standards and ensure consistency and efficiency of the clinical protocols within an indication or program for study startup standards.

Assists with protocol designs to ensure study design alignment, assessment needs, and data collection needs. Remains critical to the protocol authorization development and review process to ensure the most efficient clinical trial design

Functions as a contact with Global Clinical Trial teams for study design analysis. .

Provides ongoing feedback, coaching, and career development, including engagement and retention support to staff in order to maximize their potential. Empowers and holds GCO management to high quality performance and delivery of the business.

May represent the company in interactions with external partners as part of any business related committee or industry group.

Develops strong and productive working relationships with key stakeholders, thinks strategically and effectively express his/her views to senior management.

Ensures GCO representation as needed in governance or strategic teams or committees (preparatory materials, direct participation, or representative).

Supervisory Responsibility

5+ Study Operations & Assessment Planners

Key Stakeholders/Contacts

Global Clinical Operational team, BIA; Clinical teams, Medical Writers, scientists (Biomarkers, PK/PD,...), Data Management, Outsourcing Managers, and Central Clinical Laboratories

Qualifications:

A minimum of a Bachelor's Degree is required. A degree in Life Sciences or equivalent is preferred. At least 8 years clinical trial operations experience is required.

Comprehensive understanding of clinical drug development process.

Strong analytical skills to facilitate detecting and resolving study design problems.

Project management experience and ability to manage multiple projects.

Previous line management experience highly desired.