Senior Medical Director, Clinical Development

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. 

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 the Senior Medical Director, reporting directly to the Senior Vice President of Clinical Development, you will work in a cross-functional manner to drive the neuromuscular development programs, from early stages into and through clinical trials.  You will build strategic alliances with external stakeholders, such as KOLs, and support colleagues within Entrada by offering a clinical perspective.

Responsibilities

• Provide oversight and leadership of clinical program including planning, execution, and completion of clinical trials according to all applicable regulations and guidance, ICH/GCP, and Entrada SOPs.
• Collaborate closely with internal research team to integrate translational research into development and clinical strategies.
• 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.
• 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 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:

• Physician required (MD/DO or equivalent).
• 3+ or more years of industry and/or clinical/clinical 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.
• This is a US based remote position, with preference given to local New England based candidates. This role will require a minimum 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 $328,000 - $387,000. 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-Remote #LI-GG1

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

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