Head of Global Clinical Compliance & Continuous Improvement

Location
Princeton, NJ, USA
Salary
Competitive
Posted
Nov 09, 2017
Closes
Dec 20, 2017
Ref
2146210781
Contract Type
Full Time
Head of Global Clinical Compliance & Continuous Improvement

The Head of Global Clinical Compliance and Continuous Improvement is an executive level role considered essential to the sustainability and success of the BMS R&D pipeline. This role reports to the Head of Global Clinical Operations (GCO) and is a key member of the GCO Leadership Team.

Specifically, the Head of Global Clinical Compliance and Continuous Improvement is accountable for:

Providing strategic and operational leadership of the global clinical compliance and continuous improvement function within Global Clinical Operations (GCO). Responsible for assuring quality by design across the BMS R&D portfolio of clinical trials globally to enable the organization to be inspection and audit ready at all times. The team supports the development of the Risk Assessment & Categorization Tool developed by the clinical operations teams in support of Risk Based Monitoring (RBM).

Developing and implementing a culture of continuous improvement, ensuring that comprehensive corrective action preventative action plans (CAPA) are developed, root cause analysis is captured, trended and adaptations to process to support of a quality mindset to each audit or health authority inspection.

Leading the development of the GCO quality plan, evaluating risk parameters to assure clinical research associate (CRA), Contract Research Organization (CRO) and clinical site oversight.

Chairing the GCO issue management & compliance committee and leads the quality management system activities & processes to assure that staff understand and apply GCP, ICH quality guidelines and federal regulations.

Partnering with BMS Quality function is the key contact for any global health authority inspections - site or sponsor related activities.

Leveraging core risks and root causes identifying needs, directing development and continuous improvement of processes, systems and global strategies to support evolution of GCO business operating model with a particular focus on Good Clinical Practices (GCP).

Identifying, building and maintaining technical training program for the staff of GCO. This includes on boarding and core curriculum requirements, by role in accordance with Standard Operating Procedures (SOPs) globally.

Enabling end to end clinical trial execution through providing centralized, efficient delivery of core documentation and reporting associated with clinical trial delivery such as Clinical Trial Submissions packages, informed consent, and clinical trial transparency.

Leading a multi-national team of clinical compliance professionals, who are experts in clinical trial SOPs and GCP subject matter experts, that contribute significantly to BMS portfolio of clinical trials. 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.

Providing overall leadership and guidance across the portfolio that shapes the direction of GCO strategy to assure optimized geographic allocation of resources, focused attention to site dynamics and needs to assure GCO becomes a favored site partner.

Ensuring adaptive management of a global team through the effective deployment of resources and streamlined processes, ensuring productivity targets, validity and quality of the data gathered in support of the evolving portfolio of BMS products.

Representing the Company in key interactions with key external partners as part of any compliance committee or industry group.

Serving as a leader across R&D, and developing strong and productive working relationships with key stakeholders throughout BMS with the ability to think strategically across a broad portfolio and effectively express his/her views to senior management.

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

Engages and energizes employees through communication of goals, priorities and other business critical information as well as focus on employee value proposition, development and retention activities.

Developing and promoting a work place culture that values diversity of thought, promotes integrity and creates an atmosphere that supports coaching and fosters accountability.

Experience and expertise required:

Expert in ICH/GCP principles as it relates to clinical trial execution and impact to the business supporting clinical trial execution.

Extensive interaction with health authorities in support of inspections globally - sponsor and site.

Significant global clinical trial expertise and a successful track record of leading through influence, working across complex, global organizational matrices.

Bachelor's degree required with an advanced degree preferred. At least 10 years of relevant industry experience, with substantial experience of managing staff in a global setting.

A strong understanding of the drug development process with proven expertise in clinical trial execution and management in a global arena.

Demonstrated partnership across various collaborative forums, CROs, SMOs and/or local site networks.

Diverse and sufficient technical expertise to be a credible interface to all global development and business partners (medical, development, commercial, regulatory & quality etc.)

Broad intelligence of the clinical trial environment across key regions, and anticipation of future trends and impact.

Strong influential leadership and communication capabilities with a proven ability to engage, manage, develop and inspire a large, geographically diverse team.

We're creating innovative medicines for patients fighting serious diseases. We're also nurturing our own diverse team with inspiring work and challenging career options. No matter the role, each one of us makes a contribution. And that makes all the difference.