Job Description Summary
LOCATION: London or Dublin
ROLE TYPE: Hybrid Working, #LI-Hybrid
The Vendor Program Strategy Director (VPSD) acts as the Business Partner for all vendor activities with the Clinical Operational Program Head (COPH). The VPSD, in collaboration with the COPH, Portfolio Innovation Director (PID), the External Relationship Management Teams (ERMT) and Procurement defines the program vendor strategy end-to-end. The VPSD is accountable at program level for the vendor delivery across the clinical study lifecycle from study start-up, recruitment, maintenance and closeout in accordance with Good Clinical Practice (GCP), International Council for Harmonisation of Technical Requirements of Pharmaceuticals for Human Use (ICH), Standard Operating Procedures (SOP’s), and regulations.
Job Description
Major accountabilities:
* End-to-end accountability for all supplier related activities at a program level across Global Drug Development (GDD) Portfolio
* Manages a program view of supplier performance relative to the defined strategy
* Defines and aligns program strategies in close collaboration with Alliance Lead, ERMT, PID and Procurement
* In collaboration with Vendor Alliance Leads, reviews geographic scope of global vendors and drives local vendor service delivery discussions with country representatives in case of gaps
* Understands upcoming portfolio demand within Program through COPH role (new trials, new program, Business Development and Licensing (BD&L), research collaboration) and pushes information to Vendor organization
* Understands and translates new service needs, in advance, and engages with Vendor Alliance Lead for vendors to be identified, qualified, and contracted to support future Programs/Trials
* Support activities for Health Authority (HA) inspections/Audit readiness
* Enables early engagement with suppliers during protocol development & feasibility stage and serves as single point of contact for Trial Vendor Management Team representative for program level strategies
Key performance indicators:
End-to-end Supplier Service Delivery at the Program and Trial Level - Accountable for all external clinical activities for defined program strategies.
* Lead supplier decision making sessions with other key internal and external partners.
* Provide program pipeline visibility
* In collaboration with the ERMT, proactive vendor risk management, assessing trends, quality issues, and contract issues, driving suppliers quality improvement at program level
* Trial and Program timelines through supplier related start-up, recruitment, maintenance and closeout activities
Minimum Requirements:
* 10+ years relevant industry experience, including expertise in clinical operations leadership of multidisciplinary teams, experience management outsourced trial activities at an operational and strategic level
* Advanced degree in science or business with equivalent experience
* Demonstrated executive leadership in developing and managing external and internal strategic relationships
* Experience with clinical processes and associated supplier services, with excellent understanding of trial management, trial monitoring and overall integration of clinical data system and processes
* Strong technical and problem solving skills Excellent understanding of clinical trial methodology, GCP and medical terminology
* Excellent understanding of clinical development, quality & regulatory standards and policies relevant to defined services
* Provide thought-leading insights to the competitive environment and internal partner interfaces
* Outstanding skills to facilitate/optimize contribution of team members as individuals and members of cohesive team
Why Novartis:
Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here:
https://www.novartis.com/about/strategy/people-and-culture
You’ll receive:
You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook.
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.
Join our Novartis Network:
If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Skills Desired
Clinical Research, Clinical Trials, People Management, Program Management, Regulatory Compliance, Resource Management (Organizational), Risk Management #J-18808-Ljbffr