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entradatherapeutics
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Associate Director, Clinical Biomarkers

Оценка ИИ

Отличная вакансия в стабильной биотехнологической компании на стадии клинических испытаний с прозрачной вилкой зарплаты и сильным социальным пакетом. Позиция предлагает высокий уровень ответственности и возможность напрямую влиять на разработку лекарств от редких заболеваний.


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Сложность вакансии

ЛегкоСложно
Оценка ИИ

Высокий уровень сложности обусловлен требованием ученой степени (Ph.D.), глубокой экспертизы в специфических методах анализа (ligand binding, molecular assays) и опыта работы в строго регулируемых средах GLP/GCP. Роль предполагает как научное лидерство, так и операционное управление внешними подрядчиками (CRO).

Анализ зарплаты

Медиана190 000 $
Рынок165 000 $ – 215 000 $
Оценка ИИ

Предлагаемая зарплата ($173k - $206k) полностью соответствует рыночным стандартам Бостона для позиции Associate Director в биотехнологическом секторе, где медиана составляет около $190k. Верхняя граница диапазона даже несколько превышает средние показатели для аналогичных ролей.

Сопроводительное письмо

I am writing to express my strong interest in the Associate Director, Clinical Biomarkers position at Entrada Therapeutics. With over [Number] years of experience in clinical biomarker strategy and a deep background in developing fit-for-purpose assays, I am impressed by Entrada’s commitment to targeting previously inaccessible intracellular targets. My expertise in managing CROs and overseeing GLP/GCP-compliant validations for oligonucleotide programs aligns perfectly with your current clinical-stage DMD and DM1 franchises.

Throughout my career, I have successfully led the transition of biomarker assays from discovery to clinical implementation, utilizing platforms such as MSD, qPCR, and Western Blot. I am particularly drawn to Entrada’s collaborative culture and the "catalyst-rich" period ahead in 2026. I am confident that my technical guidance and experience in regulatory submissions (FDA/EMA) will contribute significantly to the timely delivery of your clinical readouts and the growth of your internal biomarker team.

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Откликнитесь в entradatherapeutics уже сейчас

Присоединяйтесь к Entrada Therapeutics, чтобы возглавить разработку биомаркеров для инновационных генетических лекарств и изменить жизнь пациентов с редкими заболеваниями.

Описание вакансии

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. Through proprietary and versatile approaches, Entrada is advancing a robust development portfolio of genetic medicines for the potential treatment of neuromuscular and inherited retinal diseases, among others. Our lead oligonucleotide programs are in development for the potential treatment of people living with Duchenne muscular dystrophy (DMD) who are exon 44, 45, 50 and 51 skipping amenable. Entrada has partnered with Vertex Pharmaceuticals to develop a clinical-stage program, VX-670, for myotonic dystrophy type 1 (DM1).

2026 represents a catalyst-rich period for Entrada. We expect multiple clinical data readouts as we advance several DMD programs across the U.K., EU, and U.S. By year-end 2026, we anticipate four clinical-stage programs in our DMD franchise (ENTR-601-44, ENTR-601-45, ENTR-601-50, and ENTR-601-51). These programs are complemented by the ongoing clinical progress of our DM1 collaboration with Vertex (VX-670).

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 lead clinical biomarker development and strategy at Entrada. You enjoy a fast-paced environment and juggling competing priorities. You bring an in-depth knowledge of biomarker development and strategy, as well as a broad understanding of regulatory expectations supporting assay performance across various stages of clinical development. You follow up and follow through, efficiently connecting problems with solutions. You work successfully in a team environment, with strong people skills to effectively build working relationships inside and outside of the company.

The Opportunity

The Associate Director, Clinical Biomarkers, will lead scientific efforts to develop and execute biomarker strategies in support of ongoing and future clinical trials. This individual will oversee biomarker activities across external CROs and specialty laboratories, while also conducting technical and strategic evaluations of emerging and innovative biomarker platforms to support Entrada’s drug development pipeline.

In addition, this role will provide leadership and mentorship to the internal biomarker team, supporting the growth and development of team members across varying levels of experience and expertise. The ideal candidate will demonstrate strong project management capabilities and effectively communicate progress, risks, and timelines to ensure the successful and timely delivery of biomarker assays in support of clinical programs.

Responsibilities

  • Lead internal clinical biomarker initiatives in the development, transfer, and execution of stage-appropriate biomarker assays for clinical development.
  • Effectively manage on-going activities for biomarker testing and identify technology solutions to support ongoing and planned clinical trials.
  • Demonstrate an established depth and/or breadth of expertise in biomarker assays and provide strong technical guidance; managing the assay development/transfer and oversee fit-for-purpose validation at selected vendors.
  • Contribute to biomarker-related sections of clinical study protocols and health authority submission document, where applicable.
  • Operationalize biomarker tests and ensure results are delivered and archived per clinical development needs.
  • Collaborate with Program Team Leaders, Regulatory, and Medical Directors in the review of clinical protocols, investigator training documents, lab manuals, clinical sample analysis, and regulatory submission activities for clinical development.
  • Partner with Discovery and Non-clinical Development teams in the evaluation and development of clinical biomarker assays and vendor selection for early projects.
  • Manage, identify, and communicate risks to stakeholders in a clear and timely fashion.
  • Manage and guide junior level staff for successful assay development and execution within the biomarker function.
  • Actively engage with industry professionals via attendance and delivery of presentations in conferences, workshops, focus groups, and literature/publications to guide best practices for biomarker development and clinical implementation.

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. with 6 + years of relevant experience or Master's in a scientific discipline with 8+ years relevant experience.
  • Previous experience defining and executing “fit-for-purpose” clinical biomarker assays to address key scientific and clinical questions.
  • Broad understanding of FDA and EMA requirements for biomarker regulatory sections.
  • Extensive understanding in developing, performing, and optimizing ligand binding assay technologies (e.g. ELISA, MSD) and molecular assays (e.g. qPCR, ddPCR, western blot) and related software for data analysis.
  • Experience in outsourcing and managing activities at CROs (e.g. managing timelines and technical troubleshooting) and overseeing development and validation of clinical biomarker assays in a GLP and GCP(GXP) environment.
  • Strong verbal and written communication and presentation skills.
  • Strong interpersonal skills and knowledge of intercultural differences; adept at working across multiple functions to drive decision making.
  • Experience working in a fast-paced, cross-functional environment with multiple competing priorities.
  • This role follows a hybrid working model, with in office attendance 2-3 days per week minimum 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 $173,000 - $206,000. 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-Hybrid

Equal Opportunity Employer

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 hereto understand how and when your data is being used.

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Навыки

  • Biomarkers
  • Clinical Trials
  • Assay Development
  • ELISA
  • qPCR
  • ddPCR
  • Western Blot
  • GLP
  • GCP
  • Project Management
  • FDA Compliance
  • EMA Compliance
  • CRO Management

Возможные вопросы на собеседовании

Проверка понимания концепции 'fit-for-purpose' в контексте клинических испытаний.

Опишите ваш подход к разработке и валидации биомаркерных тестов по принципу 'fit-for-purpose' для различных фаз клинических исследований.

Оценка навыков управления внешними партнерами, что критично для данной роли.

Расскажите о случае, когда возникли технические проблемы при передаче метода в CRO. Как вы их решили и обеспечили соблюдение сроков?

Проверка знаний регуляторных требований FDA и EMA.

Какие ключевые элементы вы считаете наиболее важными при подготовке разделов по биомаркерам для подачи документов в регуляторные органы (IND/NDA)?

Оценка технической экспертизы в методах, упомянутых в вакансии.

Каков ваш опыт работы с количественным анализом белков (например, Western Blot или MSD) в условиях GCP для оценки эффективности терапии?

Оценка лидерских качеств и умения работать в кросс-функциональной команде.

Как вы балансируете между научными целями команды по биомаркерам и операционными приоритетами клинической программы при ограниченных ресурсах?

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entradatherapeutics
Страна
США
Зарплата
173 000 $ – 206 000 $