Clinical Supply Integrator
- Malvern, PA 19355, USA
Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies.
In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to over 47,000 staff across a network of more than 900 independent companies in over 50 countries and operating more than 800 laboratories. Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products, as well as providing innovative clinical diagnostic testing services, as one of the leading global emerging players in specialised clinical diagnostics testing.
In 2019, Eurofins generated total revenues of EUR € 4.56 billion, and has been among the best performing stocks in Europe over the past 20 years.
As Clinical Supply Leader you are responsible for the supply chain management of clinical supplies aligned per Therapeutic Area. You are assigned to oversee a dedicated team focused on end-to-end supply chain management process.
- Responsible for CSC planning, project budgets, coordination, and decisions related to clinical supply activities resulting in uninterrupted supply.
- Set direction for one or more complex/accelerated compounds, from New Molecular Entity to Life Cycle Management.
- Lead the Clinical Supplies sub team and orchestrate all clinical supply activities to successfully deliver a clinical program.
- Drive a global team in defining and driving change, challenge the status quo and problem solving and provide coaching to team members.
- Independently manage issue escalation and resolve compound issues with limited guidance.
- Lead the monthly cS&OP cycle and take leadership over the escalation and resolution of critical risks and issues, include communication to key stakeholders.
- Ensure there is a well-designed integrated demand and supply plan from API to Kit.
- Represent 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.
- Represent DPDS (Drug product Development and Supply) at the Clinical team, ensuring clinical strategy can be executed.
- Influence the clinical teams in the trial design and operational aspects thereby ensuring cost efficiency and customer satisfaction.
- Manage 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 coverage.
- Higher degree + min 8 years related experience.
- Clinical supply design expertise (e.g., influencing clinical protocols, designing patient kits, developing distribution strategy).
- Excellent knowledge of CMC drug development process and roles.
- Experience leading and supervising late stage compound teams or multiple early projects for process development, tech transfer and regulatory filings.
- Advanced understanding and management of the E2E clinical supply budget, GXP, estimates and reporting.
- 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.
Position is full-time, Monday - Friday 9:00am - 5:00pm. Candidates currently living within a commutable distance of Malvern, PA are encouraged to apply.
- Excellent full time benefits including comprehensive medical coverage, dental, and vision options
- Life and disability insurance
- 401(k) with company match
- Paid vacation and holidays
Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.