Director, Clinical Development, Medical Monitoring Lead

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, 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.

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:

• 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.

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 280,000 – 320,000. 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