Senior Manager/Manager, Global Clinical Supply Chain Operations

Overview:

Be Seen and Heard at EyePoint

At EyePoint, leadership trusts our employees to get the job done. The patient-centric and award-winning approach we’re taking in business fuels our success for:

• preventing blindness through vision-saving medications
• delivering best-in-class proprietary pharmaceutical technologies
• transforming ocular drug delivery

• Your wellbeing
• Your professional worth
• Your future at EyePoint

EyePoint offers robust total rewards in a science-based entrepreneurial culture that empowers curiosity and innovation to help catapult your career. There’s space for every voice and perspective to be heard in our on-site and remote environments where a variety of strengths and diverse backgrounds are connected.

This role will also support and advise Clinical Operations, Regulatory, Quality and clinical sites on all aspects of CTM and comparator products as applicable. The individual will work very closely with multiple internal cross-functional partners and external vendors to ensure successful execution.

This position will be based in Watertown, MA. We offer a hybrid work schedule.

Responsibilities:

Primary responsibilities include, but are not limited to, the following:

• Responsible for implementation of global clinical supply plans, based on CMC and clinical development plans.
• Plans, establishes, manages and monitors forecast activities related to drug product, comparators and ancillary clinical supplies at the program and study level.
• Responsible for all levels of studies, ranging from simple and complex, requiring in-depth understanding of GMPs, project management, IXRS/IRT, medication management and/or use of advanced simulation tools.
• Responsible for label design, randomization, packaging, labelling and distribution of clinical supplies.
• Responsible for study budgets. Monitors spend to-date compared to the approved study budget. Accountable and responsible for amending budgets through defined management processes.
• Manages vendors to ensure timely delivery of CTM that meets study protocol, regulatory, and budgetary requirements. Ensures that key project milestones are met.
• Works with other internal functions and external partners to manage complex projects, negotiate and communicate supply plan timelines to internal and external customers and partners.
• Works with internal stakeholders to establish and ensure that regulatory, clinical, quality and CMC plans and interdependencies are thoughtfully laid out to ensure a unified approach for assurance of supply chain activities.
• Maintains and ensures compliance to all SOPs. Identifies gaps and makes appropriate mitigation recommendations to ensure global compliance. Develops new functional SOPs, as necessary, and provides training to staff.
• Manages material reconciliation and documentation to support end of study close-out.
• Maintains a continuous improvement mentality to enhance clinical supply chain processes.
• Works with internal stakeholders and vendors to create and maintain clinical supply documentation.

Qualifications:

Primary skills and knowledge required include, but are not limited to the following:

• Experience with developing risk-based clinical supply strategy for early to late-stage clinical development programs.
• Experience with supply distribution for global clinical trials.
• Excellent project management, organizational and communication skills.
• Must thrive in a fast-paced innovative environment while remaining flexible, proactive, resourceful and efficient.
• Experience managing clinical contract packaging, labeling, and procurement organizations.
• Experience with clinical trial start-up and customized IRT systems.
• Understanding of regulatory requirements for global clinical supply distribution and labeling.
• Understanding of cGMP, GCP, GDP and national/international transportation requirements for pharmaceutical materials.

Level of Education Required:

Bachelors degree.

Preferred Field of Study:

Life science, supply chain or other relevant field of study required.

Number of Years of Experience in the Function and in the Industry:

Minimum 5+ years of experience in a global Clinical Supply Chain Planning role in a Biotechnology or Pharmaceutical environment.

Envision Your Future

With the exciting energy of a winning culture and an exhilarating pace, we are an ophthalmology company committed to preventing blindness by developing and commercializing innovative therapeutics.

The collective power of our values influences everything we do, and everything we do for you.

Transformational Innovation

We exist to change our patients’ lives through the power of sight. We are forward looking, embrace challenges with curiosity, and continuously seek to improve our products and ourselves by learning, problem-solving and pushing the limits of science and technology.

Unwavering Integrity

We recognize our responsibility to our patients, employees, and our community, and value the trust they put in us. We set a high ethical bar and expect responsible leadership at every level to ensure we serve those who matter most to us.

Compassionate Excellence

We believe that fun and excellence can coexist. We foster a culture where enjoying the work we do and caring for each other are as important as delivering exceptional outcomes.

Inclusive Collaboration

We strive to see through the eyes of others and work as one team. We appreciate one another’s differences and perspectives, and ensure everyone feels valued, respected and encouraged to bring their ideas forward.

All applicants will be considered for employment without attention to age, race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or disability status.

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