Senior Scientist Regulatory Toxicology Job
Job Code - 297
Job First Active on: Tuesday, April 10, 2012
Senior Scientist, Regulatory Toxicology
Senior Scientist I, Regulatory Toxicology in the Nonclinical Development Department will be responsible for designing and overseeing the nonclinical safety testing programs for assigned IND/CTA and clinical stage candidates in development. Specific responsibilities will include:
* Collaborate with Discovery Research and Discovery Nonclinical Development (NCD) in the screening and selection of candidate compounds for progression to nonclinical testing in support of IND/CTA filings
* Design safety testing programs (including safety pharmacology and toxicology testing) for assigned IND and clinical stage candidates
* Contract research laboratory (CRO) selection/study director interactions/monitoring, study result interpretation, and report finalization
* Serve as lead Nonclinical representative on select project Core teams and/or subteams and Discovery teams
* Prepare all relevant nonclinical regulatory documents (written and tabulated study summaries in Common Technical Document format, Annual Reports, Investigator Brochures, and integrated summaries for regulatory submissions) and respond to queries from Regulatory Authorities
* Determine qualified levels of impurities to set drug substance/product specifications at all stages of clinical development.
* Participate in regulatory meetings/interactions.
* Aid in the evaluation of select in-licensing candidates
* Assess mechanism(s) of toxicity to determine clinical relevance and ways to minimize clinical impact
* Provide perspective on safety concerns prior to and during clinical trials
* Prepare nonclinical CTD summaries for NDA filing and respond to regulatory review comments.
This position regularly interacts with all levels of the organization, including Discovery NCD, NCD DMPK, Regulatory, Analytical Research, Clinical Research, Clinical PK, Quality Assurance, as well as Process Chemistry/Development and Manufacturing groups.
Minimum Basic Qualifications
Successful candidates will have a Ph.D. with 6 years post-graduate experience as a toxicologist within the pharmaceutical industry. Candidates must be familiar with the worldwide nonclinical testing guidelines to support clinical development and registrational filings. Experience in developing IND and NDA/MAA nonclinical testing programs is critical. Travel will be required of this position and is anticipated at a maximum of 20%.
* Ph.D. with 6 to 8 years as a toxicologist within the pharmaceutical industry.
* Post-doc experience preferred in toxicology or pharmaceutical development.
* Knowledge of pharmacokinetics or toxicology specialization is desirable.
* Strong computer skills with familiarity with Microsoft Word, Project, and Excel is beneficial.
* Lead experience in drafting nonclinical CTD sections for IND and NDA regulatory submissions.
* Some managerial/supervisory experience.
Desired Competencies and Qualifications:
The successful candidate will possess the following capabilities; an ability to work effectively within teams and in a fast paced and changing environment; an ability to respond enthusiastically and positively to organizational changes as well as changes in job demands; the ability to communicate clearly, concisely, and effectively to express information in both written and oral context; the ability to make sound scientific decisions by evaluating all factors and using judgment; the ability to utilize effective planning to facilitate goal achievement; the ability to pursue tasks and work towards achievement of goals with energy, drive, and initiative, even in the face of adversity and setbacks; an ability to drive issues to closure and get the job done in ways that are professional and are reflective of the Cubist code of conduct; the ability to work effectively and co-operatively with others in a team environment towards the achievement of the teams and organizations goals.
* The candidate will mainly work in an office environment and will deal mostly with the generation and review of electronic and paper files, protocols, reports etc.
* Depending upon their credentials, previous experience, and training the candidate may also assist in selected in-house testing.
* Minimal; the candidate will mainly work in an office environment and will deal mostly with the generation and review of electronic files, protocols, reports etc. Some travel (10 to 20% of time) will be required to visit and monitor toxicology work conducted by CROs on behalf of Cubist.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily within the context of the representative work environment and physical demands described above. Likewise, qualifications listed are representative of the knowledge, skills, and abilities required to perform the position’s essential functions. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
REQUIREMENTS - QUALIFICATIONS: Senior Scientist, Regulatory Toxicology
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