- Provide oversight and leadership of ocular clinical programs 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.
- 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.
- Physician preferred (MD/DO or equivalent)
- 6+ or more years of industry and/or clinical/clinical research experience.
- Experience with clinical development in Ophthalmologic 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.
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Medical Director, Clinical Development - Boston, United States - Entrada Therapeutics Inc.
Description
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-, antibody- and enzyme-based programs for the potential treatment of neuromuscular, ocular, metabolic and immune mediated diseases, among others.
Our lead oligonucleotide programs are in development for the potential treatment of people living with Duchenne who are exon 44, 45 and 50 skipping amenable.
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 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 Medical Director, reporting to the Vice President of Clinical Development, you will work in a cross-functional manner to drive the ocular development program, from candidate nomination 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.
ResponsibilitiesAt Entrada, our passion for science, our devotion to patients and our values drives our behavior:
By becoming a team member here at Entrada, you'll have access to competitive health, dental, and vision coverage, as well as life insurance, and short term and long-term disability insurance.
Our location in the vibrant and growing Seaport District is close to all the best that the city of Boston has to offer.
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 AgenciesEntrada 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 StatementEntrada 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.
