Senior Manager, Preclinical Development - Cambridge, MA
Sarepta Therapeutics is currently seeking an experienced toxicologist/pharmacologist to oversee external preclinical study collaborations. This position will oversee the design and implementation of formal (e.g., GLP) non-clinical studies to be conducted by commercial laboratories to support product development.
Primary responsibilities include:
For all non-clinical programs:
- Point of contact for collaborations/CROs in support of development teams and clinical and regulatory affairs
- Implement appropriate Preclinical Development Plans
- Preclinical toxicology support to Clinical Development and Regulatory teams (including budgeting, timing and reporting of all preclinical studies)
- Ensure all completed reports are of high quality and on time
- Ensure appropriate data interpretations
- Prepare and submit abstracts and support development of manuscripts
- Evaluation of facilities and methods to ensure suitability
- Analysis and interpretation of the results
- Present data via publications
Education and Skills Requirements:
- Ph.D. or M.D. /Ph.D. (or M.S. with 5+ years' experience), preferably in Toxicology/Pharmacology or Veterinary Medicine.
- A minimum of three years in preclinical development with emphasis in toxicology. Experience with design, conduct and interpretation of toxicity studies. Experience in NDA & IND applications. Experience in a research field related to Preclinical Development, Toxicology, and Preclinical Pharmacology.
- 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. Experience on the design, conduct, analysis and interpretation of non-clinical studies. 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 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.