Associate Director, Patient Operations Logistics (Hybrid / Remote)

Gaithersburg, US; Cambridge, US; New Jersey, US   |   full time   |   Job ID: 8640 

 

 

Responsibilities

The purpose of this role is to define and lead initiatives of all Patient Scheduling & Logistics activities in global Phase I-III clinical trials for individualized therapies.

• Manage a team of managers and specialists who are responsible for coordinating patient scheduling and logistics activities with clinical trial sites in alignment with manufacturing capacity availability.

• Ensure the development of processes and procedures to support the end-to-end individualized therapy treatment journey.

• Ensure alignment with Clinical, Commercial, Manufacturing, Quality, and other internal teams regarding the individualized therapy treatment journey.

• Lead cross-functional continuous improvement initiatives to enhance the robustness and efficiency of the individualized therapy treatment journey, including the implementation and development of state-of-the-art processes and new technology solutions. This includes making critical decisions in alignment with internal and external stakeholders.

• Contribute to the cross-functional prioritization of site slot allocation and coordinate with Product Supply, Manufacturing, and Clinical Operations on related manufacturing capacity.

• Support cross-functional scheduling and coordination meetings to ensure timely execution and product delivery to patients.

• Partner with Clinical Operations and Commercial teams to enhance patient supply in the clinical setting and support developing the future commercial patient journey operating model.

• Monitor trends and identify improvement opportunities for the Patient Operations team.

• Provide operational support as a process expert for patient operations activities.

• Represent Clinical Trial Supply Management in internal and external project and trial teams.

• Lead recruiting, coaching, performance management, and training of team members to acquire all theoretical and practical knowledge to guarantee functional management of the Patient Operations activities

 

Qualifications

 

Education

• Degree in pharmacy, chemistry, biotechnology, biochemistry, Engineering Supply Chain Management, Logistics or related discipline

 

Experience

• Relevant professional experience (usually +5 years) in Pharmaceutical or Biotech or any other equivalent industry setting (e.g. healthcare)

• Experience supporting individualized therapies, such as CAR-T Therapy or Individualized Vaccines.

• Knowledge in patient scheduling, order management, slot allocation, and logistics coordination for individualized therapies.

• Profound skills with electronic systems supporting Patient Operations Scheduling & Logistics processes, Chain of Identity process controls, and standard office software (e.g., MS Office).

• Experience in a customer service or support role is essential.

• Effective stakeholder management, both in cross-functional internal and external matrix team environment

• Demonstrated excellent leadership, communication, and presentation skills.

• Proven track record of creativity and problem solving in a regulated environment.

• Experience in writing regulatory documents and GMP procedures

• Project Management experience.

• Demonstrated quality management experience.

• Documented experience in handling deviations, changes, and CAPA

 

 

 

Your Benefits:

 

BioNTech is committed to the wellbeing of our team members and offers a variety of benefits in support of our diverse employee base. We offer competitive remuneration packages which is determined by the specific role, location of employment and also the selected candidate’s qualifications and ex