Associate Director, Clinical Operations

Location
Waltham, MA
Posted
Mar 12, 2018
Hotbed
Genetown
Required Education
Bachelors Degree
Position Type
Full time

Company Overview

Eloxx Pharmaceuticals, Inc.  (http://www.eloxxpharma.com/ ) is a clinical-stage biopharmaceutical company developing novel small molecule medicines to treat many rare and ultra-rare genetic diseases caused by nonsense mutations. Nonsense mutations are a class of genetic defects that result in premature termination of protein synthesis. These nonsense mutations have been identified in over 2,000 rare and ultra-rare diseases.  As a consequence, patients with a genetic disease caused by nonsense mutations have absent or truncated nonfunctional proteins, accounting for some of the most severe phenotypes in these genetic diseases. Eloxx’s lead product candidate, ELX-02, is an investigational, novel translational read-through inducing drug designed to restore synthesis of full-length functional proteins. ELX-02 is an investigational agent undergoing clinical trials and has not been approved by any global regulatory body. Eloxx was founded in 2013 and is headquartered in Waltham, MA. with R&D operations in Rehovot, Israel.

This is an opportunity to join a growing and energetic team, build a high performing company, gain personal development and transform patient lives.

Job Summary

The associate director is responsible for the managing appropriate planning and rigorous execution of protocols with all vendors, implementation of across functional groups, during all stages of the clinical study from protocol design to final CSR, in order to achieve corporate goals on time and on budget.

Essential Job Responsibilities

  • Ensures that clinical trial projects are properly resourced, managed and executed within budget and in accordance with established timelines and quality standards.
  • Prepares program planning with multiple clinical trials for the specific therapeutic indication. This includes a clinical plan, budget preparation and program milestone projections.
  • Lead manager of cystinosis program; oversees the preparation of protocols, amendments, CRFs, informed consent forms, operations and other documentation required for conduct of a clinical trial.
  • Maintains and manages internal clinical trial files and documents.
  • Assists with preparation of required regulatory submission documents, such as initial clinical trial applications, routine submissions, annual reports, updating of the IB, and final study reports for assigned protocols.
  • Manages the day-to-day clinical operations, including management of vendors (e.g., CRO), monitoring clinical trial recruitment rate, and coordination of activities.
  • Plans and participates in investigator meetings.
  • Coordinates and plans for the availability of clinical and non-clinical supplies necessary to meet study requirements.
  • Travel to meetings and sites when necessary.
  • Maintains multidisciplinary communications with other intracompany departments to ensure good working relationships.

Qualifications/Experience

  • The associate director should have a minimum of 10 years’ experience in the pharmaceutical industry, with minimum 7 years’ direct experience in planning and managing clinical trials.
  • The candidate must have solid understanding of pharmaceutical clinical development processes and have experience with clinical monitoring.
  • The candidate should have significant experience with responsible roles in the conduct or management of Phase I and II clinical trials.
  • The candidate must have a minimum of B.Sc. degree or equivalent biologic science degree is preferred.
  • The candidate must have a good working knowledge of medical terminology, physiology and pharmacology and an excellent knowledge of applicable U.S. and international regulations and guidelines.

Interested candidates can click "Apply now"