Director, Clinical Development, Medical Monitoring Lead

The Organization

Whats 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- and protein-based programs for the potential treatment of neuromuscular and ocular diseases among others.

Our lead oligonucleotide programs are in development for the potential treatment of people living with Duchenne who are exon 44 45 50 and 51 skipping amenable. Entrada has 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 a versatile self-motivated team player who looks forward to rolling up your sleeves to drive efficient clinical development and delivery of drugs for devastating diseases. You thrive in a fast-paced collaborative environment and can manage multiple projects concurrently. You excel at building relationships and trust with your key stakeholders in particular across nonclinical and clinical functions as well as externally. You know when to step in and lead something and when to offer your support

The Opportunity

As a Medical Monitoring Lead reporting to the Sr. Vice President of Clinical Development you will work in a cross-functional manner to drive the neuromuscular development programs and other pipeline programs as assigned from early stages into and through clinical trials and ensure patient safety throughout clinical trials. You will build strategic alliances with external stakeholders such as KOLs and support colleagues within Entrada by offering a clinical perspective.

Responsibilities

• Lead medical monitoring / reporting and safety activities in partnership with clinical sites and CROs.
• Acts as the medical contact at the company for clinical / medical issues for ongoing studies.
• Interpret and report on results of clinical studies in partnership with other internal study stakeholders for all phases of development.
• Participate or lead in safety review meetings and provide clinical input into adverse event evaluation and reporting.
• Support or when needed lead clinical program design activities 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.
• Develop and maintain relationships with key opinion leaders and Principal Investigators.
• 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.
• Support clinical content of all clinical and regulatory documents including protocols INDs CTAs investigator brochures CRFs annual IND reports CSRs ISSs ISEs and clinical expert reports.
• Support relevant clinical advisory boards data monitoring 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 drives ourbehavior :

To thrive on our team you will need to come with :

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 youll 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 Bostons 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. The final base compensation offered will depend on several considerations which include but may not be limited to a candidates 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

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 here to understand how and when your data is being used.

Required Experience :

Director

Key Skills

EMR Systems,Post Residency Experience,Occupational Health Experience,Clinical Research,Managed Care,Primary Care Experience,Medical Management,Utilization Management,Clinical Development,Clinical Trials,Leadership Experience,Medicare

Employment Type : Full Time

Experience : years

Vacancy : 1

Monthly Salary Salary : 50 - 51