Director/Senior Director, Toxicology/DMPK

Location
Waltham, MA
Posted
Feb 28, 2019
Required Education
Doctorate/PHD/MD
Position Type
Full time

The Company:

Eloxx Pharmaceuticals, Inc. is a clinical-stage Rare Disease biopharmaceutical company focused on restoring production of essential proteins depleted due to genetic mutations. Our library of novel drug candidates enable read-through of premature stop codons and have shown dose dependent improvements in restoring essential protein functions across multiple disease areas. Our lead investigational product candidate, ELX-02 has been granted Orphan Disease designation and is advancing to Phase 2 in Cystic Fibrosis and Cystinosis. Our recently announced Inherited retinal disease program and our partnership with the Foundation Fighting Blindness has created an opportunity to advance additional library compounds into clinical development. We anticipate continuing our rapid growth as the Company advances in clinical development, enters additional therapeutic areas and expands our pipeline.

Eloxx Pharmaceuticals (ELOX) is a Nasdaq listed biotechnology company headquartered in Boston MA with regional operations in New Jersey, Pennsylvania and Tel Aviv Israel.

The Role:

The Director (Sn Dir) Toxicology/DMPK is accountable for timely and effective drug safety support for programs from preclinical through marketed products. The incumbent is expected to demonstrate competency in interpreting toxicology/DMPK data, development and implementation of strategic plans for nonclinical development, as well as providing expertise and guidance in Regulatory Toxicology/DMPK to project/program teams. This individual will be highly analytical, decisive, goal-oriented, and timeline sensitive while maintaining the highest of scientific and ethical standards. The Director (Sn Dir) Toxicology/DMPK will actively participate on project/program/product teams, as well as collaborate with Discovery leadership on initiatives and assisting senior leadership in the identification and review of new business initiatives and in-licensing opportunities. The incumbent will adhere to established processes,

Responsibilities:

  • Represent Toxicology/DMPK: Provide high-level advice to project/program/product teams and senior management, including evaluation of conclusions and potential impact of study results on program and clinical/regulatory strategy.
  • Review and approve Toxicology/DMPK study protocols, reports, associated data
  • Nonclinical summaries, Regulatory submission sections and associated documentation.
  • Design, manage, analyze, review, summarize, interpret and report results of Toxicology, Safety Pharmacology and DMPK studies.
  • Maintain up-to-date Toxicology/DMPK plans (linked to overall program plans) for all projects/programs/products, including listings of studies, timelines, status and costs; update and refine as necessary.
  • Provide scientific/technical due diligence support for Business Development activities as required.
  • Prepare for and participate in regulatory agency interactions.

Qualifications:

  • Demonstrated knowledge of global regulatory requirements and expectations for nonclinical safety assessment packages to support first in human, clinical development, and product registration, including thorough knowledge of GLP, GCP, ICH and other applicable global guidelines.
  • Extensive experience in the outsourcing and external oversight of nonclinical Toxicology/DMPK studies conducted by qualified suppliers.
  • Hands-on experience in all aspects of Toxicology and DMPK study conduct including general, genetic, developmental and reproductive toxicology, carcinogenicity, toxicokinetics, ADME and safety pharmacology.
  • Experience representing function to global regulatory agencies in support of submissions at all stages of development, ie, IND/CTA, CTD, IMPD, MAA/NDA/BLA/JNDA.

Competencies Include

  • Ability to define problems, design experiments, analyze and interpret results.
  • Ability to prioritize responsibilities and meet deadlines.
  • Ability to self-motivate and work independently
  • Strong attention to detail, experience in monitoring work to assure quality, accuracy and thoroughness.
  • Excellent analytical and problem-solving skills
  • Demonstrated ability to work on complex problems and business processes in which the analysis of situations and/or data frequently requires an in-depth evaluation of multiple, interdependent factors and professional judgment.
  • Excellent communication skills with an ability to communicate across a variety of audiences including team members, cross-functional project teams, leaders, customers, and senior management.
  • Ability to work at the strategic and tactical level and comfortable shifting back and forth.
  • Enthusiastic positive upbeat “can do” attitude to the office; doesn’t take themselves too seriously, has a sense of humor
  • The ability to work well in a fast paced, innovative and performance driven environment.

Education:

  • PhD in a related subject, with DABT certification preferred, but not required.

Experience:

  • 10+ years industry-related experience in regulatory Toxicology and DMPK working within Biotech and pharmaceutical industry.
  • Experience within small and large Biotech organizations
  • Experience with both small and macromolecular/biologic drugs is highly desirable.
  • Experience in providing formal scientific/technical due diligence support for Business Development.
  • Experience in Investigative Toxicology and preclinical development of ophthalmology, pulmonary or Gene Therapy drugs is highly desirable.

In addition to offering competitive salaries, Eloxx Pharmaceuticals offers a full benefit package including healthcare, dental, vision, short and long-term disability, life insurance, 401(k) retirement saving plan, and paid holiday and vacation days.

Eloxx Pharmaceuticals is an Equal Opportunity Employer and does not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class.