Entrada Therapeutics
Senior Medical Director, Clinical Development
Entrada Therapeutics, Memphis, Tennessee, us, 37544
Overview
Senior Medical Director, Clinical Development at Entrada Therapeutics. Entrada is a clinical-stage biopharmaceutical company aiming to transform the lives of patients by engaging intracellular targets that have long been considered inaccessible. Our Endosomal Escape Vehicle (EEV)-therapeutics are designed to enable efficient intracellular delivery of a wide range of therapeutics into a variety of organs and tissues, resulting in an improved therapeutic index. Our lead oligonucleotide programs are in development for Duchenne muscular dystrophy with exon skipping amenable to exons 44, 45, 50 and 51. 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 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. This is a US-based remote position, with preference given to local New England-based candidates. The role will require quarterly travel to the Entrada Therapeutics Headquarters in Boston, MA. Responsibilities Provide oversight and leadership of clinical programs including planning, execution, and completion of clinical trials according to applicable regulations and guidance (ICH/GCP) and Entrada SOPs. Collaborate with internal research teams 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 with timely updates on progress and changes in scope, schedule, and resources as required. Ensure compliance with 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, and review and evaluate pre-clinical safety data for regulatory submission. Be responsible for the clinical content of all clinical and regulatory documents (protocols, INDs, CTAs, investigator brochures, CRFs, annual IND reports, CSR, ISS, ISE, and clinical expert reports). Organize and present at relevant clinical advisory boards, data monitoring committees, and medical/scientific meetings, including collaboration in preparation of manuscripts, posters, and other scientific communications. Travel nationally and internationally, as needed.
Qualifications
Physician required (MD/DO or equivalent). 3+ 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, with ability to contribute creative yet practical solutions. Experience with all aspects of management of clinical trials from inception to completion across all phases of development including study design. Experience in communicating and presenting key/complex information to department/functional leads and senior management. Strong knowledge of FDA and ICH regulations. Expert knowledge of Good Clinical Practice (GCP). Ability to multi-task and manage several projects in parallel with attention to detail. Ability to forge cross-functional working relationships with internal teams and external project partners, and to work collaboratively. Proactive in identifying issues and resolving them in a timely fashion. This is a US-based remote position, with preference for local New England-based candidates. Travel to the Entrada Therapeutics Headquarters in Boston, MA is required.
What We Offer
Meaningful work, fair rewards, and real support. Entrada believes in compensation transparency and equity and will share salary ranges and compensation philosophy in line with state requirements in the United States. In addition, Entrada provides comprehensive benefits including health, dental and vision coverage; life and disability insurance; a 401(k) match; paid parental leave and education reimbursement; discretionary time off; and commuting benefits. If you work from our Boston office, youll be steps from the citys offerings. 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 collaboration, curiosity and commitment that drive our mission forward. Kerry Robert, SVP of People Salary range: $328,000 - $387,000. The final base compensation offered will depend on skills, competencies, experience and other factors permitted by law. The final salary offered may fall outside this range. Equal Opportunity Employer
Entrada Therapeutics is an equal opportunity employer. Qualified candidates will receive consideration without regard to race, color, religion, national origin, gender, sexual orientation, gender identity or expression, age, mental or physical disability, 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. Resumes will be accepted only if there is a signed agreement with the recruiter/agency for a specified position. Privacy Statement
Entrada respects your privacy. Please reference our privacy statement to understand how and when your data is used. #J-18808-Ljbffr
Senior Medical Director, Clinical Development at Entrada Therapeutics. Entrada is a clinical-stage biopharmaceutical company aiming to transform the lives of patients by engaging intracellular targets that have long been considered inaccessible. Our Endosomal Escape Vehicle (EEV)-therapeutics are designed to enable efficient intracellular delivery of a wide range of therapeutics into a variety of organs and tissues, resulting in an improved therapeutic index. Our lead oligonucleotide programs are in development for Duchenne muscular dystrophy with exon skipping amenable to exons 44, 45, 50 and 51. 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 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. This is a US-based remote position, with preference given to local New England-based candidates. The role will require quarterly travel to the Entrada Therapeutics Headquarters in Boston, MA. Responsibilities Provide oversight and leadership of clinical programs including planning, execution, and completion of clinical trials according to applicable regulations and guidance (ICH/GCP) and Entrada SOPs. Collaborate with internal research teams 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 with timely updates on progress and changes in scope, schedule, and resources as required. Ensure compliance with 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, and review and evaluate pre-clinical safety data for regulatory submission. Be responsible for the clinical content of all clinical and regulatory documents (protocols, INDs, CTAs, investigator brochures, CRFs, annual IND reports, CSR, ISS, ISE, and clinical expert reports). Organize and present at relevant clinical advisory boards, data monitoring committees, and medical/scientific meetings, including collaboration in preparation of manuscripts, posters, and other scientific communications. Travel nationally and internationally, as needed.
Qualifications
Physician required (MD/DO or equivalent). 3+ 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, with ability to contribute creative yet practical solutions. Experience with all aspects of management of clinical trials from inception to completion across all phases of development including study design. Experience in communicating and presenting key/complex information to department/functional leads and senior management. Strong knowledge of FDA and ICH regulations. Expert knowledge of Good Clinical Practice (GCP). Ability to multi-task and manage several projects in parallel with attention to detail. Ability to forge cross-functional working relationships with internal teams and external project partners, and to work collaboratively. Proactive in identifying issues and resolving them in a timely fashion. This is a US-based remote position, with preference for local New England-based candidates. Travel to the Entrada Therapeutics Headquarters in Boston, MA is required.
What We Offer
Meaningful work, fair rewards, and real support. Entrada believes in compensation transparency and equity and will share salary ranges and compensation philosophy in line with state requirements in the United States. In addition, Entrada provides comprehensive benefits including health, dental and vision coverage; life and disability insurance; a 401(k) match; paid parental leave and education reimbursement; discretionary time off; and commuting benefits. If you work from our Boston office, youll be steps from the citys offerings. 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 collaboration, curiosity and commitment that drive our mission forward. Kerry Robert, SVP of People Salary range: $328,000 - $387,000. The final base compensation offered will depend on skills, competencies, experience and other factors permitted by law. The final salary offered may fall outside this range. Equal Opportunity Employer
Entrada Therapeutics is an equal opportunity employer. Qualified candidates will receive consideration without regard to race, color, religion, national origin, gender, sexual orientation, gender identity or expression, age, mental or physical disability, 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. Resumes will be accepted only if there is a signed agreement with the recruiter/agency for a specified position. Privacy Statement
Entrada respects your privacy. Please reference our privacy statement to understand how and when your data is used. #J-18808-Ljbffr