Ref #: 30718

Employment type: Permanent - Full-Time

Location: Belgium

Posted: 16-Sep-2021

Description

Key Responsibilities:

* Services include providing end-to-end supply chain management of clinical supplies. Through the Clinical Supply Chain Sub-Team develops supply strategies matching needs of clinical programs and trials to ensure on time delivery and optimal supply coverage for API, DP and Packaged materials.
* Manages budgets at a compound level and influences key stakeholders (Clinical Team, CMC Team) on the right trial design and its operational impact with a high degree of autonomy.
* Responsible for overseeing a group focused on end-to- end supply chain management.
* Services rendered will adhere to applicable SOPs, WIs, policies, local regulatory requirements, ICH-GCP, etc.
* Sets direction as the clinical supply chain project and team leader for one or more compounds, from NME to Life Cycle Management. Leads the Clinical Supplies sub team, and through the team orchestrates all clinical supply activities to successfully deliver a clinical program.
* Drives a global team in defining and driving change, challenging the status quo and problem solving and provides coaching to team members. Independently manages issue escalation and resolves compound issues with limited guidance.
* For each compound, leads the monthly cS&OP cycle and takes leadership over the escalation and (as appropriate) resolution of critical risks and issues, include communication to key stakeholders. Ensures there is a well-designed integrated demand and supply plan from API to Kit. Leads cS&OP escalation topics.
* Represents the Clinical Supply Chain at the CMC team and the Clinical team leading the product strategy. Communicates and executes the strategy and development plan with high level of autonomy and accountability. Accountability for CSC planning, project budgets, coordination, and decisions related to clinical supply activities resulting in uninterrupted supply.
* Represents DPDS at the Clinical team, ensuring clinical strategy can be executed. Influences the clinical teams in the trial design and operational aspects thereby ensuring cost efficiency and customer satisfaction, and coordinates escalation & communication to the clinical team.
* Manages the compound activities required to meet key CSC/CMC/CT milestones. This includes long range demand forecasting prior to transition to TSM, selection of formulation and comparators used in clinical trials, and developing supply strategies to meet clinical plans while optimizing drug overage.
* CMC Drug Product Development - Demonstrates in-depth knowledge of E2E CSC activities and the broader development process/organization in order to support the development G&O’s with impact on departmental strategy.
* E2E CSC accountability for portfolio projects at the CMC and clinical teams, managing internal and external stakeholders.
* Matrix Team leader- Leads the CSC sub-team applying innovative approaches and out of the box thinking while providing coaching to help develop the team members.
* Quality- Ensures Project Activity, which is safe, effective and otherwise compliant with global health authority expectations.
* Problem Solving / Decision Making - Creates a culture and empowers others in the analysis of strategic problems and issues; identifies and manages the impact across the business.
* Project Management - Leads multi-dimensional projects across the business; manages inter-relationships among projects for optimal outcomes, processes, and people.



Required experience and qualifications:

* University degree (Life sciences or supply chain) Bachelor’s degree plus 8-12 years of related experience or master’s degree plus 6+ years. Technical degree and/or experience is a plus.
* Proficient in speaking and writing the English language. (Dutch and/or French are a strong plus)
* Clinical supply design expertise (e.g., influencing clinical protocols, designing patient kits, developing distribution strategy) or equivalent (manufacturing, planning, supply chain, drug product development experience is a plus).
* Project management experience or certification are a strong plus.
* Knowledge of CMC drug development process and roles or equivalent experience.
* Experience communicating and executing strategy / product development plan with high level of autonomy and accountability.
* Experience leading and supervising late stage compound teams or multiple early projects for process development, tech transfer and regulatory filings.
* Experience interfacing directly with CMC/Tech team members, internal operations, Regulatory, SC, external service providers and internal DPDS customers such as GCO and TA with limited or no guidance.
* Advanced understanding and management of the E2E clinical supply budget, GXP, estimates and reporting.






Working at ICON is more than a job, it’s a calling for people who care and are passionate about improving patients’ lives. At ICON, we care about our people and your passion, you are key to our success. We aim to provide an open and friendly work environment where we empower our people and provide them with opportunities to develop their long-term career.
It takes courage to move from one job to another, the process involves careful consideration. Reach out having the conversation that would change your life and the lives of our patients. Our team of recruitment experts will provide the information you need in making the right decision.
At ICON you will have the opportunity to work with one of the global top 20 pharmaceutical companies, working on novel therapies that deliver real impact. If you want a career with a difference, ICON is the place for you.