Careers

Title: Associate Director, Clinical Trial Manager

Location: Waltham, MA

Entasis Therapeutics is a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of novel antibacterial products to treat urgent and serious infections as prioritized by the CDC and WHO.  The innovative and robust pipeline include two late-stage programs against highest-priority pathogens - sulbactam-durlobactam (SUL-DUR) (targeting A. baumannii infections), which has completed phase III and zoliflodacin (targeting Neisseria gonorrhoeae) that is nearing phase III completion.  Three additional programs in early-stage development include ETX0462 against Pseudomonas aeruginosa, ETX0282CPDP against MDR cUTIs, and NBP2 for Gram (-) infections.

Associate Director, Clinical Trial Manager:

This position will report to the Head of Regulatory and will be responsible for the operational management, planning, oversight and execution of all ongoing clinical trials.

  • Lead aspects of assigned clinical trials, including development of clinical operational plan and timelines based on program Clinical Development Plan
  • Ensure consistency in processes and drive Clinical Operations performance
  • Responsible for oversight of Contract Research Organizations (CROs)/study vendors, including evaluation, selection and management of CROs/vendors to ensure successful clinical trial implementation and execution and ensure proactive management of CRO performance
  • Oversee the development of and adherence to clinical trial project timelines
  • Coordinate relevant and timely exchange of information / materials (e.g., subject enrollment, site selection/feasibility, and data collection)
  • Coordinate with CMC team regarding drug forecasting and supply of drug products to sites and contribute to design and packaging of supplies for clinical programs and trials
  • Ensure monitoring plans are in place and by participating in data review
  • Adhere to clinical trial budgeting process
  • Collaborate with internal and external team members to ensure the successful conduct of clinical trials in accordance with state/federal regulations, GCP, ICH and internal SOPs
  • Represent Clinical Operations on cross-functional program teams for all assigned programs
  • Develop and implement processes across operations functions to ensure proactive inspection readiness
  • Contribute to authoring/co-ordination of clinical study protocols, informed consent forms (ICFs), clinical study reports (CSRs), sections of regulatory documents such as Investigators' Brochures, briefing books, safety updates, IND submission documents, responses to Health Authorities' questions

Qualifications:

  • BS/MS or higher in the life sciences; Clinically/scientifically savvy
  • Minimum of 3 years of progressive experience in clinical operations within biotech, pharmaceutical, or CRO industry
  • Experience with management and oversight of a CRO
  • Strong project management and communication skills
  • Experience across all phases of clinical development
  • Excellent interpersonal, communication, negotiation and influencing skills
  • Thorough understanding of country-specific, FDA (and equivalent), ICH and GCP guidelines as well as cross-functional clinical processes including data management, pharmacovigilance, biostatistics, medical writing, and regulatory affairs

Entasis is proud to be named one of the BEST workplaces in HealthCare and Biopharma by the Great Place to Work Institute and Fortune Magazine! https://www.greatplacetowork.com/certified-company/7022538

Entasis offers a comprehensive benefits package to all eligible employees including health, dental, vision, 401(k), Health Savings Account, Employee Assistance Program, Short/Long Term Disability Insurance, and Paid Time Off. 

Entasis is an equal opportunity workplace and participates in E-Verify.  We welcome diversity and are committed to creating an inclusive environment for all employees.   All employment is decided on the basis of qualifications, merit, and business need.  All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, protected veteran status or any other status protected by law.

Entasis considers the health and safety of it’s employees and community a top priority.  To be employed by Entasis you will be required to be fully vaccinated or to have met the legal criteria for a reasonable accommodation.  If you have any questions or concerns, please discuss them with your recruiter during the application/interview process.

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