The OpportunityThe Senior Manager, Clinical Supply Chain is an integral part of successfully executing Entrada's clinical development strategy. This role ensures successful execution of clinical supply operations and partners cross-functionally to deliver uninterrupted clinical supplies for our global, multi-phase clinical trials.
Responsibilities- Lead Entrada's clinical supply chain activities, including label text generation, labeling and packaging operations, global distribution, inventory management, and IP reconciliation.
- Develop and maintain comprehensive supply plans aligned with clinical enrollment projections, dosing requirements, regulatory timelines, and clinical study milestones.
- Provide operational oversight of contract organizations involved in packaging, labeling, and distribution.
- Author, review, and approve clinical label text, multi-country clinical label designs, packaging batch records, pharmacy manuals, and clinical supply sections of study-related documents.
- Manage Investigational Product aspects of IRT systems including IRT specifications for study product, product availability and release status, shipment authorizations, and maintenance of study blind integrity.
- Develop appropriate supply risk mitigation strategies and proactively identify and manage risks related to study timelines, supply availability, expiry, inventory levels, and protocol updates.
- Partner with Quality and Clinical stakeholders to facilitate the timely review, approval, and execution of standard operating procedures, batch records, lot-release documentation, change controls, deviations, investigations, and corrective and preventive actions.
- Manage sourcing of ancillary supplies for IV infusion for clinical sites.
- Ensure adherence to applicable regulations, including FDA, EMA, ICH, GCP, GMP.
The NecessitiesAt Entrada, our passion for science, our devotion to patients and our values drives our behavior:
- Humanity - We genuinely care about patients and about one another.
- Tenacity - We are relentless and persistent in the pursuit of developing therapies for patients.
- Creativity - We are creative problem solvers.
- Collaboration - We are more than the sum of our parts.
- Curiosity - We have a growth mindset and push conventional thought and theory.
To thrive on our team, you will need to come with:
- Bachelor's degree in supply chain, scientific or related field required with 8+ years of Clinical Supply Chain management in the pharmaceutical or biotechnology industry.
- Demonstrated experience planning and executing clinical supply strategies for complex, global clinical studies.
- Demonstrated experience managing clinical supply activities, including labeling, packaging, distribution, inventory management, product reconciliation, and forecasting.
- Experience supporting injectable programs requiring cold-chain storage and distribution.
- Demonstrated experience managing import and export activities for global clinical studies with a focus on North America and Europe.
- Strong operational and project management skills, with experience managing multiple programs, vendors, and deliverables simultaneously.
- Demonstrated proficiency working with 3rd party IRT systems, including IP-related specification development.
- Experience overseeing Unblinded Clinical Supply activities, including management of site pharmacy inquiries and temperature excursions.
- Excellent communication (verbal and written) and interpersonal skills.
- Ability to exercise independent judgment with minimal supervision.
This is a US based remote position, with preference given to local New England based candidates. This role will require minimum quarterly travel to the Entrada Therapeutics Headquarters located in Boston, MA.
What We Offer: Meaningful Work, Fair Rewards, and Real SupportAt Entrada Therapeutics, we understand that compensation and total rewards are a major consideration when exploring a new opportunity. We believe in transparency and equity and are committed to sharing salary ranges for every position, along with insight into our compensation philosophy, in accordance with certain state requirements in the United States and fostering a fair and open environment at the onset.
But we also know it is more than just pay. When you join Entrada, you'll be part of a mission-driven team with access to comprehensive health, dental and vision coverage; life and disability insurance; with a 401(k) match. We pride ourselves on offering competitive benefits that empower our employees and reflect the value of their contributions - offering paid, gender-inclusive parental leave, holistic support for your health and well-being, education reimbursement, discretionary time off and commuting benefits aligned to your working model. If you find yourself working from our office in Boston's Seaport District, this puts you steps away from some of the best the city has to offer.
At Entrada, our approach to compensation is grounded in transparency, equity, and performance, recognizing the unique contributions each person brings. We believe meaningful work deserves meaningful reward, and view compensation as one way to show appreciation for the collaboration, curiosity, and commitment that drive our mission forward.
The salary for this opportunity ranges from $156,525 - $183,384. The final base compensation offered will depend on several considerations which include but may not be limited to a candidate's skills, competencies, experience and other job-related factors permitted by law. The final salary offered may fall outside of this range. #LI-JF1 #LI-Remote
Pay transparency
$156,525-$183,384 USD
