The Perfect Addition to Our Team

You are interested in working at the intersection of life sciences and business. You want to join a high growth biotech company in a business strategy role to help support the team by synthesizing and communicating strategic insights from market and competitor developments. You bring to the table the combination of an inquisitive spirit, critical thinking, and analytical skills. You love following innovative science, performing data-driven analyses and contributing strategic insights. You thrive in figuring out the details and understanding the nuances while still making connections to the bigger picture. You look forward to working with and learning from cross-functional leaders across the organization while helping shape long-term strategy

The Opportunity

This individual will lead and support many different aspects of competitive and market intelligence to support new product planning. Example workstreams include competitive monitoring and tracking, conference coverage, and strategy development. The ideal candidate will conduct primary and secondary research to gather market insights and data and use them to inform analysis and planning implications. This individual will be expected to lead the Competitive Intelligence workstream and distill market insights and data in a timely manner to create concise summaries for internal communications. They will also support various strategic workstreams by conducting focused evaluations of market trends and supporting commercial assessments to help drive recommendations.

Responsibilities

Competitive Landscape

• Lead competitive intelligence activities, including tracking, analyzing, synthesizing, and communicating competitor and industry activity across key stakeholders (Strategy, Regulatory Affairs, Medical Affairs, Clinical Development, Clinical Operations, and Business Development).
• Monitor industry activity and emerging trends through conference coverage and external intelligence to inform internal decision-making.

Market Insights

• Gather, analyze, and synthesize market data to support data-driven insights and timely communication to internal stakeholders.
• Design and execute cross-functional primary market research, partnering with internal teams to define objectives, methodologies, and select vendors (HCPs, KOLs, patients, payers, and advanced analytics partners).
• Translate market research, claims analysis, and payer insights into early go-to-market strategy and commercialization readiness.

New Product Planning

• Monitor and routinely update competitor pipeline and strategic direction to inform forward-looking internal program strategy, positioning, and planning.
• Identify gaps and opportunities within the evolving landscape to support early commercial strategy development, including treatment positioning, segmentation, pricing scenarios, and foundational launch assumptions.
• Routinely present insights and strategic recommendations to senior leadership and cross-functional leadership teams to inform decision-making.
• Develop investor- and Board-facing slide decks that articulate competitive differentiation and strategic positioning.

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 of Science or Arts degree in life sciences (biology, biochemistry, chemistry, etc.) required; advanced degree preferred (PhD, MS, or equivalent).
• 4+ years of experience in biotech/pharma in roles such as competitive intelligence, market insights, or management consulting with a life sciences focus.
• Strong scientific literacy with the ability to interpret clinical and preclinical data.
• Direct experience synthesizing and communicating accurate, timely competitive insights on drug development / corporate strategy.
• Experience in designing and conducting interviews with external experts or KOLs is strongly preferred.
• Excellent communication skills, with the ability to synthesize complex information into clear recommendations and present insights effectively using Microsoft PowerPoint and Excel.
• Ability to work independently in a fast-paced, innovative, and collaborative environment, with a strong team-oriented mindset, can-do attitude, and flexibility to adapt based on new insights and team input.
• This position is a US remote-based position requiring a minimum of 1-2 days per week onsite at the Entrada Therapeutics Headquarters in Boston, MA.

What We Offer: Meaningful Work, Fair Rewards, and Real Support

At 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.

“Our approach to compensation is grounded in transparency, equity and performance for the unique contributions each person brings. At Entrada, we know that meaningful work deserves meaningful reward — and we view compensation as one way we show appreciation for the collaboration, curiosity and commitment that drive our mission forward.”

— Kerry Robert, SVP of People

The salary for this opportunity ranges from$127,000-$166,000. 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-Remote #LI-GG1

The Perfect Addition to Our Team

We are looking for someone who is enthusiastic about modeling and the big picture of drug development. You are passionate about joining a growing organization where your knowledge and experience are highly valued. You thrive in a collaborative environment, working with others to enhance infrastructure throughout the organization. You follow up and follow through, efficiently connecting problems with solutions

The Opportunity

We are seeking a dynamic and motivated Senior Pharmacometrician with deep quantitative pharmacology expertise who will report to the Head of Clinical Pharmacology and partner closely across functions within a growing organization. The ideal candidate will have a strong background in the applications of model-based drug development within the biotechnology or pharmaceutical industry. The ideal candidate is passionate about translating science into approved and accessible medicines

Responsibilities

• Use modeling approaches to advance clinical and translational research at Entrada Therapeutics.
• Lead cross-functional teams with scientific acumen to develop and execute pharmacometrics for programs across all phases of drug development.
• Support the development of diverse modeling strategies and execution, in collaboration with the Head of Clinical Pharmacology, to bring value to the Entrada portfolio.
• Work collaboratively with functional partners, including Clinical Development, Biostatistics, Non-Clinical Product Development, Clinical Operations, and Regulatory to deliver on both project team and corporate objectives.
• Author regulatory documents including analysis plans, study reports, population PK reports, exposure-response analyses reports and other similar documents.
• Execute pharmacometrics analyses independently to support internal and external decision making and address key drug development questions.
• Integrate pharmacometrics insights into core deliverables supporting drug development milestones and governance or decision boards.
• Monitor work with CROs and other external vendors to ensure compliance with agreed protocols, quality standards, and timelines.

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:

• Ph.D. in pharmaceutical sciences, pharmacology, pharmacometrics, pharmacokinetics, or related discipline or Pharm.D. or M.D. with relevant experience. 
• 3+ years’ experience with a background in the application of mathematical, pharmacokinetics, and statistical methods within pharma/biotech industries or drug development.
• Experience using Phoenix WinNonlin, R, NONMEM, MATLAB, or other pharmacokinetic and modeling software.
• Strong mathematical model development and analytical skills.
• Proficient documentation and organizational skills, as well as proven ability to be self-motivated and able to work independently.
• Excellent communication and presentation skills to efficiently relay information to project teams and other key stakeholders.
• This is a US based remote position, with preference given to local New England based candidates. This role will require minimum monthly or quarterly travel to the Entrada Therapeutics Headquarters located in Boston, MA.

What We Offer: Meaningful Work, Fair Rewards, and Real Support

At 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.

“Our approach to compensation is grounded in transparency, equity and performance for the unique contributions each person brings. At Entrada, we know that meaningful work deserves meaningful reward — and we view compensation as one way we show appreciation for the collaboration, curiosity and commitment that drive our mission forward.”

— Kerry Robert, SVP of People

The salary for this opportunity ranges from $180,000-$236,000. 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 

The Perfect Addition to Our Team

You are passionate and dedicated to your work, with a commitment to overcome challenges and deliver on our potential to develop transformative therapies for patients and their caregivers. You bring energy and enthusiasm to your role, while recognizing that a steady and consistent effort is required to successfully develop novel medicines.

The Opportunity

The Regulatory Affairs team at Entrada is a dynamic, growing team. The Associate Director will support global regulatory activities for Entrada’s pipeline, with a focus on clinical-stage assets. Reporting to the Senior Vice President, Regulatory Affairs, the ideal candidate will collaborate with cross-functional teams to efficiently advance the global development of genetic medicines for rare and serious unmet medical needs. This high-impact role will be critical to the success of the Regulatory department and Entrada’s mission to discover, develop and commercialize life-changing medicines that are safe, effective and accessible to those who need them.

Responsibilities

• Support the global regulatory strategy for multiple clinical stage programs.
• Partner on the development, preparation, and timely completion of health authority submissions, including the authoring, submission, and archiving for IND, CTA, and EU-CTR submissions.
• Develop strong working relationships with Regulatory colleagues and cross-functional project teams to support achievement of timelines and portfolio deliverables.
• Maintain strong relationships and communication with external stakeholders, including regulatory agencies, CROs, CDMOs, consulting groups, and other third parties.
• Collaborate with various departments including Nonclinical, Quality, Manufacturing, and Clinical to maximize opportunities while ensuring alignment with regulatory requirements.
• Lead or contribute to the development and review of procedures and work instructions aligned with GxPs, Guidance, industry standards, and corporate objectives.
• Participate in study team meetings, providing updates and addressing questions.
• Proactively identify opportunities and risks within our Regulatory department and the development programs, and support approaches to mitigate and resolve risks.

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:

• BS or MS with at least 6+ years of increasing responsibility in Regulatory Affairs; an advanced degree, RAC, or education in a scientific field preferred.
• A demonstrated record of accomplishment, including support and execution of both US and global regulatory strategies (ie, with IND, CTA, CTR, NDA, BLA, and/or MAA activities).
• Knowledge of the drug development process, GxP regulations, ICH, and FDA Guidance.
• Experience with rare diseases, pediatrics, genetic medicines, or leveraging expedited development pathways (eg, accelerated approval) is strongly preferred; experience with neuromuscular or ocular therapeutic areas is a plus.
• A strong work ethic, excellent verbal and written communication skills, and a desire to work collaboratively with matrixed project teams.
• Excellent organizational skills and the ability to work on multiple projects with tight timelines.
• A motivated and driven attitude, with a proactive work style and a results-oriented mindset.
• Integrity, a desire to learn and grow, and a commitment to excellence.
• 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 Support

At 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.

“Our approach to compensation is grounded in transparency, equity and performance for the unique contributions each person brings. At Entrada, we know that meaningful work deserves meaningful reward — and we view compensation as one way we show appreciation for the collaboration, curiosity and commitment that drive our mission forward.”

— Kerry Robert, SVP of People

The salary for this opportunity ranges from $171,000-$204,000. 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-GG1 #LI-Remote

The Perfect Addition to Our Team

You are excited about the opportunity to contribute to the growth of the program management function here at Entrada. You live in the details and enjoy connecting the dots of complicated development plans, but you are also interested in the strategy and science those details support. You welcome the opportunity to wear many hats and deepen your knowledge across functions. You work successfully in a fast-paced team environment and have strong interpersonal skills. You are a proactive communicator and are always willing to assist your team members in their shared goal of transforming the lives of patients.

The Opportunity

The Manager, Program Manager (PM) will provide comprehensive program management support across multiple clinical development programs, ensuring alignment with cross‑functional strategic and operational objectives. Success requires exceptional attention to detail, strong forward‑planning and organizational capabilities, and the ability to effectively engage, influence, and manage stakeholders across diverse teams.

Responsibilities

• Provide program management support to multiple clinical development project/program teams.
• Develop and maintain detailed end-to-end integrated program timelines; track and monitor key interdependencies and milestones.
• Support development of program meeting agendas and outcomes; document and track actions and decisions.
• Collaborate with cross-functional teams to ensure alignment with company and program objectives.
• Identify and track program risks, issues, and dependencies; ensure communication and awareness across key stakeholders.
• Apply PM best practices and methodologies to contribute to the growth and development of the Program Management Team.

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:

• BA/BS degree required, with 8+ years in clinical and drug development within the biotech/pharmaceutical industry, with 3+ years in clinical-stage project/program management.
• Strong understanding of drug development and how various functions integrate.
• Proficiency in project management software (MS Project) and experience with timeline visualization software (e.g. OnePager).
• Excellent organizational skills and attention to detail.
• The ability to work effectively across functions.
• Ability to manage multiple priorities in a fast-paced, dynamic environment.
• Excellent verbal and written communication skills.
• Desire to work in an innovative and collaborative environment.
• PMP preferred but not required.
• This is a US based remote position, with preference given to local New England based candidates. This role will require regular on-site presence at the Entrada Therapeutics Headquarters located in Boston, MA

What We Offer: Meaningful Work, Fair Rewards, and Real Support

At 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.

“Our approach to compensation is grounded in transparency, equity and performance for the unique contributions each person brings. At Entrada, we know that meaningful work deserves meaningful reward — and we view compensation as one way we show appreciation for the collaboration, curiosity and commitment that drive our mission forward.”

— Kerry Robert, SVP of People

The salary for this opportunity ranges from $127,000-$159,000. 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 

The Perfect Addition to Our Team

You are intellectually curious and can bring new ideas and perspectives to lead the development, implementation, and management of our investor relations function. You follow up and follow through, efficiently connecting problems with solutions. You work successfully in a fast-paced team environment and have strong interpersonal skills, effectively building working relationships with leaders across the Company and with outside parties.

The Opportunity

The Executive Director, Investor Relations will be responsible for developing and executing a comprehensive investor relations strategy that enhances Entrada’s visibility, credibility, and positioning within the financial community and broader stakeholder landscape. Reporting to the Chief Financial Officer, the ideal candidate will combine deep investor relations and financial expertise with strong scientific and clinical fluency to build investor confidence, drive awareness, and support long-term shareholder value creation for a NASDAQ-listed biotechnology company with an expanding portfolio of clinical-stage programs.

Responsibilities

• Drive the strategic direction, planning, and execution of the investor relations function, including financial communications, while building and continuously strengthening a best-in-class investor relations program.
• Serve as a trusted advisor to senior leadership by providing insight and guidance on investor messaging, communications effectiveness, market dynamics, and investor sentiment.
• Act as the primary point of contact to the investment community, responding to external inquiries in an accurate, appropriate, and timely manner; establish and maintain strong relationships with biotechnology-focused buy-side and sell-side analysts and institutional investors.
• Develop and maintain proactive engagement with investors and analysts to clearly communicate the Company’s long-term vision, clinical and platform strategy, differentiation, opportunity, risk factors, and key milestones.
• Lead the development and coordination of financial and investor communications—including earnings releases, investor webcasts, investor presentations, Company corporate presentations and investor relations section of the Company website
• Coordinate cross-functionally with Finance and Legal to support the timely and compliant execution of external financial disclosures and investor communications including periodic reports (Form 10-K and Form 10-Q), annual proxy statements and other reports.
• Lead the Company’s participation in investment community events, including investor conferences, non-deal roadshows, analyst days, and targeted investor meetings.
• Develop, track, and report key investor relations metrics in our Irwin investor relations system to assess program effectiveness and inform continuous improvement.
• Monitor published research analyst reports covering the Company and analyze biopharmaceutical industry trends, investor perceptions, and competitor communications to inform strategic positioning and messaging.
• Support capital markets activities, including potential financings and strategic transactions, in close partnership with the CFO and senior leadership.
• Partner closely with the Chief Corporate Affairs Officer to ensure alignment with the broader corporate communications strategy and Entrada brand.
• Manage external agencies and vendors, as needed, ensuring high-quality deliverables and disciplined management of external spend.
• Ensure all investor communications and activities fully comply with SEC regulations and disclosure requirements, including Regulation FD and NASDAQ listing standards.

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 required; advanced degree (PhD, MD, MBA, or MS in life sciences, biotechnology, or finance-related discipline) preferred.
• 10+ years of progressive experience in investor relations within the biotechnology or pharmaceutical industry.
• Experience supporting investor relations for a publicly traded biotechnology or pharmaceutical company, preferably NASDAQ-listed.
• Experience in a clinical-stage or pre-commercial biotechnology environment strongly preferred.
• Established relationships within the biotechnology buy-side and sell-side community strongly preferred.
• Proven ability to develop and execute investor relations strategies that effectively reach and influence target audiences.
• Strong financial acumen and financial modeling familiarity, with the ability to clearly communicate complex financial and clinical information to diverse external stakeholders.
• Develop clear and compelling PowerPoint presentations for earnings calls, investor meetings, and board discussions that translate complex financial and strategic information into concise, visually compelling narratives.
• Demonstrated experience supporting equity offerings, capital markets transactions, or other strategic financings preferred.
• Demonstrated ability to lead the use of investor relations software solutions to support investor engagement, shareholder monitoring and analytics, Irwin experience preferred.
• Excellent written and verbal communication skills, with exceptional attention to detail.
• Highly self-directed with exceptional project management and organizational skills, and the ability to prioritize multiple high-impact workstreams and deadlines.
• Experience building, managing, and scaling investor relations capabilities across internal teams and external partners (e.g., agencies, vendors, consultants).
• Demonstrated ability to work collaboratively and influence across functions and with senior executives to support the achievement of business objectives.
• Deep understanding of the drug development lifecycle and the regulatory and disclosure environment for biopharmaceutical companies, including SEC and Regulation FD requirements.
• Experience preparing senior executives and Board members for investor engagement and earnings communications preferred.
• Ability to travel approximately 25% as required to support investor engagement and key industry events.
• This is a US based remote position, with preference given to local New England based candidates who can be in office 1 day per week to the Entrada Therapeutics Headquarters located in Boston, MA.

What We Offer: Meaningful Work, Fair Rewards, and Real Support

At 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.

“Our approach to compensation is grounded in transparency, equity and performance for the unique contributions each person brings. At Entrada, we know that meaningful work deserves meaningful reward — and we view compensation as one way we show appreciation for the collaboration, curiosity and commitment that drive our mission forward.”

— Kerry Robert, SVP of People

The salary for this opportunity ranges from $292,000-$335,000. 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-GG1 #LI-Remote 

The Perfect Addition to Our Team

You are a motivated, resourceful, and enthusiastic Drug Substance Development & Manufacturing expert excited to support the company at a critical stage in its growth trajectory. You excel at peptide and/or oligonucleotide late-stage process development, GMP manufacturing and supply chain of drug substances. You thrive when performing these activities with minimal supervision in a collaborative matrix environment. At Entrada, you will not be siloed, but rather expected to interact across different functional groups, including Chemistry, Analytical, Drug Product, Quality, and CDMOs. Your ability and desire to thrive in a nimble, fast-paced results-driven environment will set you up for success.

The Opportunity

The Associate Director of Drug Substance Development and Manufacturing will lead and manage late-stage drug substance development for Entrada’s novel pipeline programs. This role will be instrumental in supporting development activities for clinical and commercial batches and ensuring validation parameters for manufacturing batches.

Responsibilities

• Facilitate timely execution, disposition, and release of intermediate/drug substance batches through detailed technical review of master batch records, executed batch records and other cGMP documentation.
• Partner with internal and external Quality Assurance, Quality Control and Technical Operations teams to execute late-stage development activities such as Process Characterization and Process Performance Qualifications.
• Act as a person-in-plant for smooth execution of critical manufacturing activities for clinical and commercial batches.
• Conduct risk assessments and develop mitigation strategies for manufacturing-related issues.
• Identify and resolve manufacturing issues and escalate appropriately to internal and/or joint governance if required.
• Implement and manage the Continuous Process Verification (CPV) program to ensure manufacturing process remain in a constant state of control and meet validated parameters.
• Author/review change controls to introduce process improvements through the lifecycle of programs from Phase 1 through Phase 3/validation and commercialization
• Work closely with other internal functions including chemistry, analytical, quality control, quality assurance, DP, and regulatory affairs to ensure programs are effectively supported and high-quality standard maintained.
• Partner with Entrada team for CDMO due diligence during new CDMO selection to vet capabilities, risks and investments required.
• Author/review related sections in regulatory filing documents (IND, IMPD, NDA, BLA, MAA, etc.).
• Other tasks as assigned or as required for a given program.

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:

• Master’s or suitable advanced degree in organic chemistry or other scientific or engineering discipline with 8+ years of related experience in pharmaceutical industry.
• Demonstrated proficiency in process development, tech transfer, scale-up, GMP manufacturing DS for clinical, and commercial supplies.
• Proficient in managing activities and resolving manufacturing challenges at CDMOs during routine cGMP manufacturing and process validations.
• Experienced in onboarding/managing/collaborating with CDMOs, raw material suppliers, testing partners, and other production partners.
• Hands-on experience in SPPS/SPOS, downstream purification and lyophilization is highly preferred.
• Demonstrated ability to develop and maintain production timelines and budgets.
• Up-to-date with industry practices and regulations (e.g. GxP, ISO, ICH, etc.) across multiple health authorities (e.g. FDA and EMA).
• Ability to interpret and relate Quality standards for implementation and review.
• Strong project management, interpersonal, communication, and problem-solving skills preferable.
• Ability to communicate clearly and professionally both in writing and verbally.
• Ability to travel up to 20% (domestic and international).
• This is a US based remote position with preference given to local New England based candidates. This role will require minimum monthly or quarterly travel to the Entrada Therapeutics Headquarters located in Boston, MA.

What We Offer: Meaningful Work, Fair Rewards, and Real Support

At 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.

“Our approach to compensation is grounded in transparency, equity and performance for the unique contributions each person brings. At Entrada, we know that meaningful work deserves meaningful reward — and we view compensation as one way we show appreciation for the collaboration, curiosity and commitment that drive our mission forward.”

— Kerry Robert, SVP of People

The salary for this opportunity ranges from $172,000-$202,000 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 

The Perfect Addition to Our Team

You are passionate about clinical trial research and driven to advance drug development through rigorous analytics. With a strong foundation in statistics and clinical methodologies, you combine classical techniques with cutting-edge innovations. You thrive in fast-paced settings, handle competing priorities with ease, and eagerly step in where needed. You are results-oriented and collaborative, and you thrive when build strong relationships across teams to deliver impactful solutions.

The Opportunity

Reporting to the Senior Director, Biometrics, this individual will contribute to daily statistical activities and support the development of statistical approaches for clinical trials. Working closely with internal and external stakeholders, you will help manage a growing portfolio of trials.  This role also offers the opportunity to support the continued growth of the biostatistics function at Entrada and gain valuable experience in a collaborative, fast-paced environment. 

Responsibilities

• Support statistical strategy for assigned drug programs, including input to clinical development plans, clinical study concepts and protocols design, SAPs, clinical study reports, regulatory documentation and associated publications.
• Accountable for oversight of the production of biostatistics deliverables (TFLs, including planned, post-hoc, and/or exploratory analyses) as performed by external resources.
• Provide statistical strategy support and input in protocols, CSRs, and scientific presentations and manuscripts.
• Review the randomization procedures and oversight of the production of randomization lists.
• Review study Case Report Forms, data management plan and other data management related documentation to ensure that specific statistical requirements defined in the study protocol are met.
• Oversee outsourced statistical CRO activities and deliverables, ensuring high quality and timely delivery.
• Produce innovative tools and methodologies for statistical analysis through literature review.
• Participate in the development of department strategies and cross functional initiatives on standards, infrastructure, and processes.

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:

• Ph.D. in Statistics or a related field, with 6 + years of experience in statistical analysis within the biotech/pharmaceutical industry.
• Experience with a broad array of statistical approaches and experience in proposing novel approaches to support acceleration of clinical programs. Knowledge in the latest developments in the analytical world including machine learning and artificial intelligence is a plus.
• Solid understanding of regulatory guidelines on drug development, regulatory submissions, and statistical practice.
• Strong statistical programming skills (R, SAS, Python).
• Understanding of regulatory guidelines related to submission of datasets using CDISC, development of SDTM and ADaM specifications.
• Previous vendor management experience is preferred.
• Previous experience in Neuromuscular, Ophthalmology or related TA is preferred.
• Excellent verbal and written communication skills with a strong attention for detail.
• This is a US based remote position, with preference given to local New England based candidates. This role will require a minimum quarterly travel to the Entrada Therapeutics Headquarters located in Boston, MA.LI-JF1 #LI-Remote 

What We Offer: Meaningful Work, Fair Rewards, and Real Support

At 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.

“Our approach to compensation is grounded in transparency, equity and performance for the unique contributions each person brings. At Entrada, we know that meaningful work deserves meaningful reward — and we view compensation as one way we show appreciation for the collaboration, curiosity and commitment that drive our mission forward.”

— Kerry Robert, SVP of People

The salary for this opportunity ranges from $190,000-$231,000. 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 

The Perfect Addition to Our Team

You are a seasoned leader in the pharmaceutical industry who is eager to shape and implement clinical outsourcing strategies for clinical trials. You are well organized and collaborative, able to work seamlessly with teams to drive our clinical activities. You thrive in a fast-paced environment, juggling priorities, and stepping in wherever needed. With a proven track record in scaling operations within biotech or pharmaceutical settings, you are a results-driven problem solver who efficiently connects problems with solutions. Your strong interpersonal skills enable you to build effective relationships inside and outside the company. If you're passionate about making a difference and driving results, we want to hear from you!

The Opportunity

The Associate Director, Clinical Outsourcing, will be responsible for development and execution of Entrada’s clinical outsourcing strategy and will manage vendor outsourcing, negotiation, and contracting for Entrada clinical studies. This role reports to the Executive Director, Clinical Business Operations, and sits within the Clinical and Business Operations and Biometrics department.  The successful candidate for this role will demonstrate an in-depth knowledge of outsourcing models and strategies, negotiations and contracting, study financials, and cost-effective best practices, as well as a thorough understanding of clinical operations, clinical trial services, and clinical technologies.

Responsibilities

• Develop Entrada’s long-term Outsourcing strategy in support of the DMD and Ocular Franchises, inclusive of full-service CROs, functional service providers, bioanalytical laboratories, ancillary services and technology service providers.
• Independently lead and be accountable for the vendor selection and onboarding process, including preparing RFPs, leading the review of proposal responses, conducting complex budget analysis comparisons and negotiations, and coordinating vendor qualification with QA.
• Identify opportunities to reduce costs, increase efficiency, and mitigate risk related to outsourced services across the portfolio.
• Lead and manage large, complex contract and financial negotiations with external service providers (including detailed scopes of work, exhibits, payment terms, budgets, and change orders) to ensure favorable terms and risk mitigations.
• Manage review and negotiation of contract business terms and partner with internal stakeholders, Legal, and Finance as needed to finalize terms and obtain approvals.
• Support development and negotiation of MSAs, quality agreements, and vendor oversight plans.

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 life sciences, business, or a related field; advanced degree preferred.
• 10+ years of progressive leadership experience in clinical operations or related areas, with at least eight years of clinical operations or outsourcing experience.
• Expert in outsourcing and contracting best practices for all phases of clinical research with an in-depth understanding of the drug development process and cross-functional responsibilities, including clinical trial design, study start-up and execution, monitoring, and site management, safety reporting, data management, and biometrics.
• In-depth experience soliciting and critically evaluating CRO and service provider proposals, negotiating contractual terms, and growing and fostering long-term, healthy vendor relationships.
• Strong attention to detail, analytical, negotiation, and business communication skills.
• Ability to interact and influence effectively with multi-functional teams at all internal and external organization levels.
• Forward-thinking and creative with high ethical standards.
• Ability to work in a fast-paced professional environment with changing priorities and business needs.
• Strong problem-solving and multi-tasking skills.
• Well-organized and self-directed.
• This is a US based remote position with preference given to local New England based candidates. This role will require minimum monthly or quarterly travel to the Entrada Therapeutics Headquarters located in Boston, MA.

What We Offer: Meaningful Work, Fair Rewards, and Real Support

At 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.

“Our approach to compensation is grounded in transparency, equity and performance for the unique contributions each person brings. At Entrada, we know that meaningful work deserves meaningful reward — and we view compensation as one way we show appreciation for the collaboration, curiosity and commitment that drive our mission forward.”

— Kerry Robert, SVP of People

The salary for this opportunity ranges from $173,000-$203,000. 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