Band

Level 5

Job Description Summary

LOCATION: Dublin, London
ROLE TYPE: Hybrid Working, #LI-Hybrid

The Associate Director Clinical Compliance and Processes, in close collaboration with the Head Clinical Compliance & Processes, ensures that Clinical Development (CD) across Development Units (DU) operates according to Novartis quality standards and in line with Health Authority regulations. Guides CD Process SMEs in the development and implementation of cross-functional processes.
Assists the Head Clinical Compliance & Processes in supporting clinical associates as part of Clinical Trial Teams (CTT) for audits and Health Authority inspections and support the coordination of inspections for CD.

Job Description

Major accountabilities:

Represents CD at the Global Process and Governance Board (GPGB) reviewing change requests, endorsing SOP, WP, ATTs and ensuring CD subject matter experts (SMEs) are adequately involved in process reviews and updates.
Maintain SME database for CD. Function as GCP SME where needed and coaches the community of CD SMEs in process simplification in alignment with regulations
Defines the applicability of GxP training, develops adequate curriculums and oversees training compliance for CD roles and. Represent CD on training initiatives
Assists Head Clinical Compliance & Processes in overseeing the development & completion of Corrective Actions & Preventive Actions (CAPA), Quality Issues (QI), and driving the continuous assessment of CD quality and compliance risks; proposes and eventually leads corrective, preventive or improvement activities. Oversee QIs of CD in collaboration with Global Clinical Operations Compliance Manager to perform investigation and root cause analysis

Supports Head Clinical Compliance & Processes for inspection readiness of CTTs and provides support & guidance for on-time delivery of Health Authority pre-requests, responses during/after inspections and closing actions
Ensures that CD process SMEs have prepared aligned process storyboards, CD associates are trained to explain process evolution from study start to end and documents are up to date to support CD members for inspections
May deputize for Head Clinical Compliance & Processes in representing CD in the Inspection Center of Excellence and Inspection Compliance Committee as business lead contributing to the improvement of inspection-related processes, quality, and compliance across functions and units
Represent CD in routine Inspection calls and in inspection related discussions
As agreed with Head Business Solutions, represents CS & CD in cross-functional initiatives in Development
Oversee Risk-Based Quality Management activities for CD
In collaboration with quality system owners, process owners and CD Process SMEs, supports assessment of new regulations on clinical processes and oversight of required changes; supports review of draft Health Authority guidance
Supports Head Clinical Compliance & Processes, Process Owners and CD Process SMEs with integration of Quality Management System for BD&L and Merge & Acquisitions
Helps to drive a curious, inspired, and unbossed culture within and outside of CS & CD and is seen as a role model of collaboration for joint success

Education:

Advanced degree in life sciences/ healthcare (or clinically relevant degree) is required. Master, PharmD, or PhD strongly preferred

Experience:

≥5 year experience in life sciences/ healthcare/pharma industry
Experience in clinical trial leadership is a plus
Thorough knowledge of Good Clinical Practice, regulations, and Quality Management Systems
Experienced in designing effective and efficient end-to-end processes across functions and units
Excellent analytical and data driven mind-set
Action orientated mindset: make things happen
Strong skills in leading and managing cross-functional projects/teams with significant (visible) business impact
Demonstrated courage to assume personal accountability in challenging situations
Needs to be able to work independently
Excellent interpersonal and communication skills
Excellent influencing, negotiation and conflict resolution skills
Expertise in organization dynamics
Act as change agent and actively generate and foster creativity and innovation in CD
Strong project management skills
Leadership presence with the ability to present and interact with senior management

Commitment to Diversity and Inclusion:

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Skills Desired

Adaptive Strategy And Innovation, Clinical Research, Cross-Functional Teams, Drug Development, Financial Management, Interpersonal Communication Skills, Microsoft Project, Npd (New Product Development), Pmi (Project Management Institute), Pmp (Project Management Professional), Program Management, Project Delivery, Project Execution, Project Life Cycle, Project Planning, R&D (Research And Development), Resource Allocation, Risk Management, Senior Management, Stakeholder Management, Time Management Skills, Waterfall Model

Associate Director Clinical Compliance & Processes

Job Description