Director, Clinical Operations - Boston, United States - Entrada Therapeutics Inc.

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 immune mediated 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 excited about the opportunity to build and develop the clinical operation function at Entrada.

You are well-organized and like to share best practices in clinical operations that you've gleaned over the years to guide the clinical team.

You also enjoy a fast-paced environment and juggling competing priorities and are willing to jump in and help, wherever it is needed.

You follow up and follow through, efficiently connecting problems with solutions.

You work successfully in a team environment and with strong interpersonal skills in order to effectively build working relationships inside and outside of the company.

The Opportunity

We are seeking a motivated Director of Clinical Operations to join and grow our evolving team here at Entrada Therapeutics.

The Director of Clinical Operations will report into the Senior Vice President, Clinical Operations and Data Management, and oversee the strategic and tactical planning and execution of the DMD portfolio of clinical assets.

This includes the oversight of all operational aspects of our clinical trials.

You will be responsible for planning all activities related to global and/or regional clinical trials, from initial planning & study start-up through close out activities.

You will be able to build out and manage a small team of clinical professionals to help support the goals of the organization.

The ideal candidate will provide strategic direction and oversight, in partnership with the extended Clinical Development team.

Responsibilities

• Accountable for the oversight and operational delivery of complex rare disease clinical trial programs in collaboration with other key functional areas, external vendors, and advisors.
• Provide leadership, line management, and professional development to a small team of clinical professionals to support the DMD & rare disease portfolio.
• Accountable for ensuring operational excellence against established operational standards, approved budgets, and timelines.
• In collaboration with the Medical Director, contribute to protocol development and study design. Oversee the protocol feasibility, site feasibility, and site selection process.
• Lead the development of the clinical study program, including critical path activities, enrollment projections, interdependencies, and milestones, and ensure accurate tracking and reporting of study metrics and timelines.
• Promote effective partnerships among internal and external stakeholders and provide day-to-day direction for the program and study team. Lead problem-solving and resolution efforts. Provide dedicated and creative recommendations on how to meet goals and handle identified risks.
• Responsible for the oversight, performance, and management of clinical CROs, vendors, labs, and consultants involved in the day-to-day study management activities.
• Oversight of the development of clinical program plans and study manuals and documents.
• Responsible for managing program and study budgets, contract negotiation, payments, and forecasting study spending. Accountable for providing monthly/quarterly and yearly updates.
• Ensure trial adherence to International Conference on Harmonization (ICH) Good Clinical Practice (GCP), appropriate Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines.
• Communicate project status, including risk identification and escalation of ongoing issues, to senior leadership to ensure timely decision-making and overall risk mitigation.
• Ensure quality clinical data review and data integrity for assigned clinical trial(s).
• Participate in and respond to Quality Assurance and/or regulatory authority inspections as needed.
• Assume a leadership role in developing Clinical Operations infrastructure, functions, standards, processes, and IT systems to optimize all aspects of clinical trial operations in compliance with global regulatory standards (e.g., SOP development, training, etc.).

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 health sciences or related field, or equivalent.
• Minimum of 12+ years of experience in clinical research with at least 8 years of experience in clinical study management, CRO, and vendor oversight.
• Experience working on rare disease, neuromuscular, or muscular dystrophy clinical trials strongly preferred.
• Experience across Phase 1 through 3 clinical trial execution with a strong preference for regulatory filing and inspection experience, globally
• Extensive and comprehensive knowledge of Good Clinical Practice (GCP), Federal Regulations, and International Regulations (International Harmonization Committee-ICH Regulations).
• Excellent organizational, communication, interpersonal, and decision-making skills. Demonstrates innovation. Possesses drive, energy, and enthusiasm to deliver the program objectives.
• Ability to problem solve and use clear judgment in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical programs.
• Ability to effectively communicate and interact with co-workers at all levels and to work independently and in teams.
• Minimum of 4 years of direct people management experience with demonstrated ability to build, coach, and develop high-performing teams, excellent delegation, and conflict resolution skills.
• Strong computer literacy and skills.
• Fluent in English (oral and written).
• Moderate travel (domestic and international), up to 25% may be required.
• Travel to headquarters in Boston; cadence to be defined.

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.