Associate Director, Clinical Supply Chain

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Job description

The Organization

What's happening at Entrada Therapeutics? Entrada is a clinical-stage biopharmaceutical company aiming to transform the lives of patients by establishing a new class of medicines that engage intracellular targets that have long been considered inaccessible.

Our Endosomal Escape Vehicle (EEV )-therapeutics are designed to enable the efficient intracellular delivery of a wide range of therapeutics into a variety of organs and tissues, resulting in an improved therapeutic index. Through this proprietary, versatile and modular approach, Entrada is advancing a robust development portfolio of RNA-, antibody- and enzyme-based programs for the potential treatment of neuromuscular, ocular, metabolic and immunological diseases, among others.

Our lead oligonucleotide programs are in development for the potential treatment of people living with Duchenne who are exon 44, 45 and 50 skipping amenable. We have also partnered to develop a clinical-stage program, VX-670, for myotonic dystrophy type 1.

We are a tight-knit team of experts and leaders in both therapeutic development and rare diseases and are excited to grow and attract colleagues who are ready to join a high-energy, dedicated team that likes to get things done and dramatically improve the lives of patients and their families.

The Perfect Addition to Our Team

You are patient focused and excited about the opportunity to lead, establish, and execute the clinical supply functionality at Entrada. You enjoy a fast-paced environment and juggling competing priorities. You follow up and follow through, connecting problems with solutions efficiently. You work successfully in a team environment with strong interpersonal skills to effectively build working relationships inside and outside the company.

The Opportunity

We are seeking a Clinical Supply Chain leader who is experienced, highly energetic, and committed to helping develop and execute Entrada's supply strategy across all clinical programs. The individual's day-to-day will span across demand management, supply planning, and vendor forecast management, working cross-functionally internally and with external vendors to ensure delivery of an effective supply chain strategy.

Responsibilities

• Mange Entrada's end-to-end supply chain, including demand/supply/capacity planning, material sourcing, label text generation/approval (MELT), clinical labeling and re-labeling of vials (expiration date updates), packaging, inventory management, cold chain shipping, import and export, and global distribution.
• Work with cross-functional team to develop study-specific IRT specifications and requirements from an Investigational Product (IP) management perspective.
• Identify supply accountability tracking and ensure Master, Pharmacy, Subject Logs are appropriate.
• Ensure appropriate documentation of IP supply activities is provided to the Trial Master File.
• Develop and follow appropriate Supply Chain SOPs.
• Build and execute forecast models for ongoing and future clinical studies.
• Manage sourcing of ancillary supplies for IV infusion for clinical sites
• Support pharmacy manual and dose preparation generation.
• Work closely with CMC, Clinical Operations and clinical packaging sites to ensure clinical drug inventory levels are maintained in accordance with study plans.
• Identify and oversee third-party vendors to support Entrada's global clinical programs.
• Develop appropriate supply risk mitigation strategies and identify and communicate risks to clinical program timelines from manufacturing delays.
• Ensure adherence to applicable regulations, including FDA, EMA, ICH, GCP, GMP.

The Necessities

At 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.
• Extensive Knowledge and proficiency of IRT system use and development for open label and double-blind studies.
• Strong working knowledge of GMP, GCP regulations, labeling, packaging and distribution operations.
• Experience working with third-party P&L CMOs and managing supply chain vendors.
• Strong organizational and forecasting skills.
• Ability to strategically plan, proactively organize and manage multiple projects simultaneously.
• Experience managing temperature-controlled cold chain shipments globally.
• Proficiency in Microsoft applications and Inventory Management systems.
• 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.

The Perks

By becoming a team member here at Entrada, you'll have access to competitive health, dental, and vision coverage, as well as life insurance, and short term and long-term disability insurance. We value work life balance, you'll benefit from discretionary time off, paternity leave, and an excellent 401(k) package. We also offer a generous transportation stipend to commute as you wish. Our location in the vibrant and growing Seaport District is close to all the best that the city of Boston has to offer.

Entrada Therapeutics is an equal opportunity employer. Qualified candidates will receive consideration for employment without regard to race, color, religion, national origin, gender, sexual orientation, gender identity or expression, age, mental or physical disability, and genetic information, marital status, citizenship status, military status, protected veteran status or any other category protected by law.

Third Party Staffing Agencies

Entrada does not accept unsolicited resumes from any source other than directly from candidates. For the protection of all parties involved in the recruiting process, resumes will only be accepted from recruiters/agencies if a signed agreement is in place at the inception of the recruiting effort and authorized for a specified position. Unsolicited resumes sent to Entrada from recruiters/agencies do not constitute any type of relationship between the recruiter/agency and Entrada and do not obligate Entrada to pay fees if we hire from those resumes.

Privacy Statement

Entrada Therapeutics, Inc. (the "Entrada," "we," "us," or "our") respects your privacy and we want you to be familiar with how we collect, use, share, or otherwise process, your Personal Information. Please reference our privacy statement here to understand how and when your data is being used.

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