Scientist II, Nonclinical Safety

Other jobs >> General

Negotiable

Permanent

Description

The Position:

The Scientist will serve as a primary source of scientific expertise for the design, analysis, reporting and presentation of data from nonclinical studies conducted to support research and development. This position will focus on nonclinical development of gene therapies. The individual will be responsible for the implementation of formal (e.g., GLP) nonclinical studies to be conducted by contract research organizations (CROs) and will oversee external collaborations with CROs and academic institutions.

Primary responsibilities Include:

- Point of contact for collaborations/CROs in support of development teams and clinical and regulatory affairs

- Execute appropriate nonclinical development plans

- Support early discovery efforts as directed

- Support investigative/mechanistic research efforts

- Nonclinical study support to Clinical Development and Regulatory teams (including budgeting, timing, and reporting of all nonclinical studies and assuring compliance with all appropriate regulatory guidance)

- Prepare nonclinical sections of all regulatory submissions for assigned development projects and interact with regulatory agencies, as needed

- Ensure appropriate data interpretations of the results from nonclinical studies

- Prepare and submit abstracts and support development of manuscripts for publication

- Evaluation of CROs and academic facilities and methods to ensure suitability

- Train on all required SOPs and WIs for inspection readiness (GLP compliance) purposes

Education and Skills Requirements:

- Ph.D. degree in Toxicology or related field with at least 3-5 years relevant experience

- Board certification preferred (American Board of Toxicology)

- Experience in nonclinical development of gene therapies. Ability to design, conduct, analyze, and interpret nonclinical studies.

- Experience in preparing NDA & IND applications.

- Familiarity with GLP requirements and ICH guidelines, experienced in management of external academic collaborations and CROs. Proficient in scientific documentation supporting submissions to regulatory agencies. Training in Animal Use Protocols as PI, or sponsor

- An excellent scientific/clinical background as demonstrated through publications in basic medical science journals. Experience with designing, conducting, analyzing and interpreting non-clinical studies

- Proficient in various computer programs such as GraphPad Prism, Word, PowerPoint, and Excel. Win-Nonlin a plus

- Able to manage/advance programs: 1) alone, as a team member or leader; 2) with consultants, and outside collaborators; 3) CROs with demonstrated success

- Proven ability to build productive relationships within internal or external teams

Candidates must be authorized to work in the U.S.

Sarepta Therapeutics offers a competitive compensation and benefit package.

Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.
  • 1
  • Negotiable
  • None
  • None
  • Re-182540
  • Permanent
  • 0

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