Director, Clinical Development, Medical Monitoring Lead

Entrada Therapeutics Inc.•Boston, MA

70d•Remote

About The Position

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- 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. 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 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.

Requirements

MD/DO or equivalent with board certification preferred.
2+ or more years of industry and/or clinical/clinical research experience.
Direct experience serving as a medical monitor within rare disease clinical studies.
Strong scientific background.
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.
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.

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, CRF's, annual IND reports, CSR's, ISS's, ISE's, 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.