Associate Director, Clinical Outsourcing

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profile Job Location:

Boston, NH - USA

profile Monthly Salary: $ 173000 - 203000
Posted on: 2 days ago
Vacancies: 1 Vacancy

Job Summary

The Organization

Whats 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 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. If youre passionate about making a difference and driving results we want to hear from you!

The Opportunity

The Associate Director Clinical Outsourcing will be responsible for development and execution of Entradas clinical outsourcing strategy and will manage vendor outsourcing negotiation and contracting for Entrada clinical studies. This role reports to the Executive Director Clinical Business Operations and sits within the Clinical and Business Operations and Biometrics department. 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.

Responsibilities

  • Develop Entradas 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.

The Necessities

At Entrada our passion for science our devotion to patients and our values drives ourbehavior:

  • Humanity - We genuinely care about patients and about one another.
  • Tenacity - We are relentless and persistent in the pursuit of developing therapiesfor 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:

  • Bachelors 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.
  • This is a US based remote position with preference given to local New England based candidates. This role will require minimum monthly or 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 youll 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 Bostons 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 $173000-$203000. The final base compensation offered will depend on several considerations which include but may not be limited to a candidates skills competencies experience and other job-related factors permitted by law. The final salary offered may fall outside of this range. #LI-JF1 #LI-Remote

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

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.


Required Experience:

Director

The OrganizationWhats 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 ...
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Key Skills

  • Program assessment
  • FDA Regulations
  • Manufacturing & Controls
  • Program Evaluation
  • budget forecast
  • Research Experience
  • Operations Management
  • Research & Development
  • Strategic Planning
  • Contract Management
  • Leadership Experience
  • negotiation

About Company

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Overcoming the challenge of intracellular target access to transform the treatment of devastating diseases.

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