Clinical Supply Chain Manager – Clinical Trials (Pharma/Biotech)

Job Description:

Duration: 1 year

Location: Gaithersburg MD 3X a week onsite

Working Hours: normal business hours 8-5

Onsite role ; Non Local need to relocate at own expense if position is offered ; no relocation assistance offered

Interview Process: 1 virtual interview (45-1 hour)

Title: Supply Chain Manager for Clinical Trial medications

The arena:

Would you like to utilize your planning and supply chain knowledge to lead clinical supplies for your portfolio of global clinical studies? With constant new products and launches, there has never been a better time to join Global Clinical Supply Chain and shape our future with a significant contribution to life-changing medicines.

We have an exciting opportunity for talented Supply Chain Managers to join our Clinical Study Supply Chain team in Gaithersburg, Maryland. This is a key role within our Clinical Manufacturing and Supply teams, and we make sure clinical trial medications are available at the right quality, in the right quantity at the right time for every patient taking part in trials all over the world. Our goal is to never miss a patient.

In Pharmaceutical Technology and Development (PT&D) we are the bridge which turns forward-thinking science into actual medicines that help millions of people around the world. We work across the entire value chain, crafting and delivering active ingredients, formulations and devices required to support new medicines – from supplies for use in early toxicology studies and clinical trials to developing the technology to ensure drugs can be scaled up for commercial manufacture.

Tasks and responsibilities/The role:

In this role you will project manage the design, plan, and set-up of the study supply chain to ensure on time delivery of clinical supplies. You will also lead a cross-functional team enabling continuous dialogue with both internal and external partners on study design requirements and associated changes which may impact the supply chain elements of the study.

To be successful in this role you need to be a fast learner, self-driven and comfortable working in a high pace R&D environment. You need to be a collaborative team player, flexible and have strong communication, planning and problem-solving skills.

Your main responsibilities will include:

• Project manage the delivery of clinical supplies effectively and consistently, and input to the balance of costs and any risks to supply.

• Ensure effective communication with project teams and key partners across a global network.

• Support risk management of individual studies with proactive mitigation of risks that potentially impact the quality or delivery of supplies.

• Take ownership for Inventory management including any rework and recalls, extensions of shelf life and expiry date management, or stock destruction.

• Manage the Interactive Response Technology (IRT) system to execute demand and supply planning.

• Work within GMP Quality Management Systems ensuring that you actively handle any deviations, complaints and change controls.

Essential requirements:

• Bachelor’s Degree in a scientific or supply chain subject area – equivalent experience will be considered.

• Experience within a supply chain management environment with a holistic knowledge of end-to-end supply chain activities

• Experience of demand planning and forecasting and risk identification and management

• Experience in running projects and influencing customer demands.

• Excellent English written and verbal communication skills.

• Proficient IT skills with an ability to adapt and operate in bespoke multiple systems.

Desirables:

• Awareness of GMP (Good Manufacturing Practise) and GCP (Good Clinical Practice)

• Knowledge of clinical development processes relevant to the supply of clinical materials

• Lean knowledge and understanding

• Experienced in handling Quality Events (Deviations, Change Controls, Complaints)

Soft skills:

• Strong influencing, negotiating and problem-solving skills, across geographical and cultural boundaries

• Ability to adapt and operate in bespoke multiple systems.