Senior Director, Clinical Pharmacology

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Job 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 immunological 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 have also 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 excited about the opportunity to develop and build the Clinical Pharmacology function at Entrada. You enjoy a fast-paced environment and juggling competing priorities. You follow up and follow through, efficiently connecting problems with solutions. You work successfully in a team environment, with strong people skills to effectively build working relationships inside and outside of the company.

The Opportunity

Reporting into the VP, Clinical Development, the ideal candidate will have a strong knowledge of best practices in Clinical Pharmacology and Pharmacometrics, extensive experience in designing and executing clinical pharmacology studies, and a demonstrated ability to make data-driven decisions based on preclinical and clinical information.

Responsibilities

• Responsible for strategic planning and execution of clinical pharmacology and modeling and simulation (M&S) activities as a core member of program teams, and leading collaborations with cross-functional teams as well as external partners as necessary.
• Drives the necessary PKPD, exposure response and translational modeling and quantitative pharmacology activities to achieve mechanistic understanding of novel drug candidates, and support optimal dose and dosing schedule decisions.
• Supervises, plans, designs, executes and reports program-specific clinical pharmacology studies (e.g. assessment of QT, ADME, DDI strategy, special populations, etc.) to support development and registration of Entrada products, by working cross-functionally with preclinical development team, clinical development, biomarkers, and other partners.
• Partners with research leads for the design and data analysis/interpretation of pharmacokinetic (PK), toxicokinetic and pharmacodynamics (PD) aspects of preclinical studies.
• Works in close collaboration with colleagues in discovery, nonclinical research, clinical development, clinical operations, and project management to author/contribute to IND/CTA submissions and other regulatory submissions, initiation of clinical development programs, late-stage development, and interactions with health authorities.
• Monitors work with CROs and other external vendors to ensure compliance with agreed protocols, quality standards and timelines.
• Accountable for adherence to agreed timelines and budgets to ensure execution of deliverables from Clinical Pharmacology studies and programs Collaborate cross functionally with all relevant areas to support corporate objectives.

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:

• Ph.D. in pharmaceutics, pharmacokinetics, pharmacology, pharmacometrics, or related discipline, or Pharm.D. or M.D. with relevant experience.
• Minimum 8 years of experience in the biotechnology or pharmaceutical industry including a strong understanding of early and late drug development process from IND/CTA through NDA/BLA.
• Direct experience in leading clinical pharmacology activities in drug development programs, from early exploratory studies to Phase 2/3 programs.
• Experience in translational research and/or pharmacometrics and its application to drug development, including PKPD, exposure response and translational modeling activities to support optimal dose and dosing schedule decisions.
• Strong fundamental or research background with interest in understanding PK and PK/PD data in the context of complex biology.
• Preferred scientific and clinical background in Neuromuscular and/or Neurology.
• Preferred experience with oligonucleotides.
• Proficient in using Phoenix WinNonlin, R, NONMEM, MATLAB or other pharmacokinetic and modeling software.
• Strong documentation and organizational skills, as well as proven ability to be self-motivated and able to work independently.
• Excellent communication and presentation skills to efficiently relay information to project teams and other key stakeholders.
• Understand cross-functional needs and ability to serve as a matrix leader or lead in a matrix environment.
• Ability to effectively recruit, guide, and train junior staff.

The Perks

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. We value work life balance, you'll benefit from discretionary time off, paternity leave, and an excellent 401(k) package. We also offer a generous transportation stipend to commute as you wish. 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 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

Entrada 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.

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