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Director/Senior Director, Clinical Development

Summary Sheet: Executive Positions

Advertiser NameEntrada TherapeuticsAdvertiser Type:Agency
Classification:Executive PositionsSubclassification:
Country:United StatesLocation:United States
Language:English - United Kingdom (en-GB) Contact Name:
Employment Type:PermanentWorkhours:Full Time

Position: Director/Senior Director, Clinical Development

Description: The Organization

What's happening at Entrada Therapeutics? Our mission is to transform the treatment of devastating diseases by establishing a new class of medicines to engage intracellular targets that have long been considered inaccessible and undruggable.

Our Endosomal Escape Vehicle (EEV )-therapeutics represent a fundamental advancement in the field of intracellular therapeutics. They 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 our EEV platform, we are building a diverse pipeline of RNA-, antibody- and enzyme-based programs for the potential treatment of neuromuscular, immunological, ocular and metabolic diseases, among others.

Our lead oligonucleotide programs include ENTR-601-44 and ENTR-601-45 for the potential treatment of people living with Duchenne who are exon 44 and 45 skipping amenable, respectively, as well as our partnered candidate ENTR-701 targeting myotonic dystrophy type 1 (DM1).

We are a tight-knit team of experts and leaders in both therapeutics 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 love to impart your clinical knowledge early into the drug development process to set the company up for success through subsequent phases. In doing so, you enjoy partnering with cross functional subject matter experts internally and externally. You have a strategic mindset but have no problem rolling up your sleeves to implement the work that needs to get done. You are a self-starter and an effective communicator. You take accountability for known project responsibilities, but you can also easily adapt and accommodate the unexpected. You thrive in a fast paced, highly collaborative, flexible working environment.

The Opportunity

The Director/Senior Director, Clinical Development is responsible for the design, planning, and medical oversight of clinical studies for all phases of development for neuromuscular programs from early (phase 1) clinical development through regulatory approval. She or he will report into the Executive, Medical Director. The Senior Director, Clinical Development will collaborate with Clinical Operations for study implementation and serve as medical monitor. The Senior Director, Clinical Development will also oversee interpretation and dissemination of study results, including clinical study reports and related publications.

The Director/Senior Director, Clinical Development will serve as a core member of the clinical development team and will contribute to the overall clinical development strategy and ensure all activities occur in compliance with the appropriate regulations. The opportunity includes providing support to translational medicine efforts within Entrada's neuromuscular programs, working closely with research to define strategy and grow the discovery pipeline.


  • Provide oversight and leadership of clinical programs including planning, execution, and completion of clinical trials according to all applicable regulations and guidance, ICH/GCP, and Entrada SOPs.

  • Partner with Clinical Operations to ensure all clinical study activities are completed in accordance with applicable regulations and guidance; ICH/GCP, and Entrada SOPs.

  • Review clinical data from all phases of development and assist in generating study reports and publications.

  • Develop and maintain relationships and serve as the main medical liaison with key opinion leaders and Principal Investigators.

  • Represent Entrada in interactions with regulatory agencies.

  • Provide management personnel with timely updates on progress and changes in scope, schedule, and resources as required.

  • Ensure compliance with all applicable regulatory standards related to global clinical trials and interactions with physicians.

  • Develop and maintain professional relationships with academic and community-based study sites involved in clinical development programs.

  • Collaborate closely with internal research team to integrate translational research into development and clinical strategies.

  • Lead internal and external team members, vendors, and consultants to develop regulatory submission packages, as well as review and evaluate pre-clinical safety data for regulatory submission.

  • Be responsible for the clinical content of all clinical and regulatory documents, including protocols, INDs, CTAs, investigator brochures, CRF's, annual IND reports, CSR's, ISS's, ISE's, and clinical expert reports.

  • Organize and present at relevant clinical advisory boards, data monitor committees and medical/scientific meetings, including collaboration in preparation of manuscripts, poster, and/or other scientific communications.

  • Travel nationally and internationally, as needed.

The Necessities

At Entrada, our passion for science, our devotion to patients and our values drive 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:

  • Physician preferred (MD/DO or equivalent)

  • 6+ or more years of industry and/or clinical/clincal research experience.

  • Experience with clinical development in Neurology/Neuromuscular disorders.

  • Strong scientific background.

  • Strong project planning, leadership, negotiation and presentation skills as well as an ability to contribute creative yet practical solutions to problems.

  • Experience with all aspects of management of clinical trials from inception to completion across all phases of development including study design.

  • Experience in communicating/presenting key/complex information to department/functional lead(s)/senior management.

  • Strong knowledge of FDA and ICH regulations.

  • Expert knowledge of Good Clinical Practice (CGP).

  • Ability to multi-task and manage several projects in parallel, paying attention to detail.

  • Ability to forge cross-functional working relationships with internal teams and external project partners, and work in a collaborative manner.

  • Ability to be proactive in identifying issues and hurdles that may hinder the effective implementation of the trial and resolve the issues in a timely fashion.

The Perks

As 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.

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