Associate Director, Clinical Outsourcing

Entrada Therapeutics•Boston, MA

13d•$173,000 - $203,000•Remote

About The Position

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. You are a seasoned leader in the pharmaceutical industry who is eager to shape and implement clinical outsourcing strategies for clinical trials. You are well organized and collaborative, able to work seamlessly with teams to drive our clinical activities. You thrive in a fast-paced environment, juggling priorities, and stepping in wherever needed. With a proven track record in scaling operations within biotech or pharmaceutical settings, you are a results-driven problem solver who efficiently connects problems with solutions. Your strong interpersonal skills enable you to build effective relationships inside and outside the company. The Associate Director, Clinical Outsourcing, will be responsible for development and execution of Entrada’s clinical outsourcing strategy and will manage vendor outsourcing, negotiation, and contracting for Entrada clinical studies. The successful candidate for this role will demonstrate an in-depth knowledge of outsourcing models and strategies, negotiations and contracting, study financials, and cost-effective best practices, as well as a thorough understanding of clinical operations, clinical trial services, and clinical technologies.

Requirements

Bachelor’s degree in life sciences, business, or a related field; advanced degree preferred.
10+ years of progressive leadership experience in clinical operations or related areas, with at least eight years of clinical operations or outsourcing experience.
Expert in outsourcing and contracting best practices for all phases of clinical research with an in-depth understanding of the drug development process and cross-functional responsibilities, including clinical trial design, study start-up and execution, monitoring, and site management, safety reporting, data management, and biometrics.
In-depth experience soliciting and critically evaluating CRO and service provider proposals, negotiating contractual terms, and growing and fostering long-term, healthy vendor relationships.
Strong attention to detail, analytical, negotiation, and business communication skills.
Ability to interact and influence effectively with multi-functional teams at all internal and external organization levels.
Forward-thinking and creative with high ethical standards.
Ability to work in a fast-paced professional environment with changing priorities and business needs.
Strong problem-solving and multi-tasking skills.
Well-organized and self-directed.

Responsibilities

Develop Entrada’s long-term Outsourcing strategy in support of the DMD and Ocular Franchises, inclusive of full-service CROs, functional service providers, bioanalytical laboratories, ancillary services and technology service providers.
Independently lead and be accountable for the vendor selection and onboarding process, including preparing RFPs, leading the review of proposal responses, conducting complex budget analysis comparisons and negotiations, and coordinating vendor qualification with QA.
Identify opportunities to reduce costs, increase efficiency, and mitigate risk related to outsourced services across the portfolio.
Lead and manage large, complex contract and financial negotiations with external service providers (including detailed scopes of work, exhibits, payment terms, budgets, and change orders) to ensure favorable terms and risk mitigations.
Manage review and negotiation of contract business terms and partner with internal stakeholders, Legal, and Finance as needed to finalize terms and obtain approvals.
Support development and negotiation of MSAs, quality agreements, and vendor oversight plans.