Senior Manager, Clinical Supply Chain f/m/d (Contract)
ATAI Life Sciences
Contract Duration: 12 months
Work Hours: 40 hours/week
Position Type: Fixed-term contract
Location: DE / UK
Senior Clinical Supply Chain Manager defines and executes an optimal clinical trial supply strategy for a clinical trial, including effective risk management to ensure patient supply continuity, while maintaining quality and compliance through all activities. They will have end-to-end operational responsibility for assigned activity and will oversee and manage all project and local network activities and participate in cross-functional teams. This role will report to the Head of Clinical Operations and be a member of the Research & Development Chapters.
atai’s Development Chapter designs and conducts clinical trials for the compounds that we are developing. They create and implement our global clinical development strategy, trial execution, and network with external partners.
Who we are:
atai Life Sciences is a biopharmaceutical company focused on developing novel treatments for mental health disorders so that everyone, everywhere, can live a more fulfilled life. To achieve this, we are developing psychedelic and non-psychedelic compounds and cutting-edge digital therapeutic tools, and we are excited about anything that might mean a true leap forward for our patients. We operate a hybrid virtual/in-person working model, with most of the team spending 2-3 days in the office, and our hubs are located in Berlin, New York City, and San Diego.
What you will achieve:
During your first 6 months, you will have assumed clinical trial supply responsibility for assigned studies across Phase 1 and Phase 2 programs, and you will have contributed to the planning and coordination of drug products to depots and clinical trial sites, globally. You will support the finalization of high-priority GxP SOPs (Standard Operating Procedures). In your first 6-9 months, you will have conducted gap analysis and risk assessment of all clinical supply activities and identified process improvements (internally and with vendors). By the end of the first year, you will have successfully embedded clinical trial supply processes into the day-to-day running of our trials – forging excellent working relationships across atai and its subsidiaries.
The specifics of your day-to-day will include:
- Designs and executes supply chain strategies that deliver on the R&D ambition while ensuring consistent on-time delivery of clinical trial supplies to participants with minimal waste.
- A member of the core squad who defines and advises the squad on the optimal clinical trial supply strategy in terms of packaging design, technical and timeline feasibility, efficiency, and risk management.
- Reviews overall clinical trial protocol and provides inputs to develop optimal packaging design, clinical trial supply design, and visit schedule.
- Creates and maintains complete and accurate clinical supply demand planning for assigned study in alignment with protocol requirements, key study parameters and milestones, patient projections, with appropriate safety stock and by using defined processes and systems.
- Creates and drives the finalization of the packaging design (Clinical Packaging Request) and a comprehensive label strategy for all participating countries in the clinical trial.
- Defines clinical supply parameters for IRT setup and initiates subsequent updates throughout the duration of the clinical trial
- Develops and executes a trial-level project plan together with all other relevant roles.
- Mitigates and manages supply chain risks, ensuring continuity and security of supply while working within the current regulatory environment.
- Collaborates with all relevant line function partners for country submission and approval timelines (including IND-IMPD amendment) to develop optimal supply strategy
- Generates optimal distribution plans for investigational medicinal products (IMPs), jointly with partner functions. Triggers and tracks shipments of IMPs from the central depot to regional hubs and local depots.
- Develops, maintains, and executes an optimal resupply strategy with proactive planning, appropriate lead-time, and replenishment quantities to ensure compliance and continuity of clinical supplies, including proactive expiry management of clinical supplies.
- Is responsible to consolidate, maintain, and track the clinical trial budget with key stakeholders for overall clinical trial supply external costs (e.g., labels, packaging, distribution, and comparators).
- Ensures adequate, proactive exchange of relevant knowledge & information between the CMC team and the study squad.
Qualifications / experience that we'd like to see:
- BS degree or higher in life sciences
- At least five years of experience in the pharmaceutical industry
- Experience in the management of clinical trial supplies including, but not limited to planning, forecasting, inventory management, clinical packaging, distribution, and IRT
- Experience managing controlled substances is a plus
- Able to work collaboratively on multi-disciplinary project teams and develop productive relationships with external vendors.
Who will be successful in this role:
Those who succeed at atai will be strongly aligned with our values:
- ❤️ Conscious Care: We take every action in service of our ultimate goal: to heal mental health disorders for all while caring for ourselves and our team.
- 🦸 Bold Entrepreneurship: We are “loosely coupled but tightly aligned” as we strive for excellence over perfection, fast and focused to accelerate innovation for patients.
- 🧑🤝🧑 Collaborative Innovation: individuals and teams work together with good humor and no drama, valuing different perspectives and diversity of thought, background, nationality, and style.
- ✋ Radical Responsibility: We take full responsibility for our circumstances. We grow and learn from failures, always looking to improve.
At atai, we value diversity of thought, background, and experience. We encourage applications from everyone everywhere – especially women, people of color, and members of the LGBTQIA+ community.
Research shows that members of minority groups are less likely to apply for a job unless they believe they meet all the requirements listed. Even if you feel that you do not meet 100% of the job criteria, we’d love to hear from you.
You might be a great fit for another position now, or in the future. We look forward to hearing from you!
Check out the video below to learn more about why we do what we do!