Toxicologist - Associate Research Fellow - Groton, CT | Biospace
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Toxicologist - Associate Research Fellow

Pfizer Inc.

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Location:
Groton, CT
Posted Date:
1/21/2017
Position Type:
Full time
Job Code:
28132.59245
Salary:
Required Education:
Doctorate/PhD
Areas of Expertise Desired:

Job Description

About Pfizer
A career at Pfizer offers opportunity, ownership and impact. All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.

Role Description
Toxicologist responsible for nonclinical regulatory strategy, and design and execution of nonclinical studies primarily in support of anti-infectives portfolio. Toxicologist will also be part of a global nonclinical team supporting generics, sterile injectables and biosimilars across multiple therapeutic areas.

Responsibilities
* Regulatory strategy: Prepare and review correspondence with worldwide regulatory agencies. Respond to nonclinical queries from regulatory agencies. Serve as an expert nonclinical safety consultant regarding current international regulatory guidelines
* Portfolio: Focus area will be design and execution of nonclinical strategy for support of anti-infectives portfolio. In addition, the toxicologist will work collaboratively with a small nonclinical team to support a diverse portfolio that includes generics/sterile injectables (to support ANDA and 505b2 submissions) and biosimilars across multiple therapeutic areas
* Contribute expert nonclinical safety sections to regulatory dossiers and oversee the integration of all nonclinical contributions (pharmacology/ADME/toxicology) * Participate in due diligence efforts - identify potential gaps and/or opportunities in nonclinical components of business development activities
* Demonstrate subject matter expertise in at least one of the following areas: impurity, excipient, and leachable/extractable safety qualifications, developmental and reproductive toxicology, genetic toxicology
* Work with other subject matter experts across the broader R&D organization as needed to address nonclinical needs of the portfolio
* External influence efforts will focus on development and implementation of strategies to influence the regulatory environment in support of streamlining registration processes

Requirements

Qualifications
* The incumbent must have a PhD, MD, or DVM in Toxicology with work experience (>10 years) in pharmaceutical industry with a thorough understanding in pharmaceutical drug development/discovery
* Experience in nonclinical aspects of pharmaceutical drug development, late-stage project strategy, and regulatory submissions and strategy
* Demonstrated communication skills both verbally and written and a demonstrated ability to collaborate as a part of a global matrix of multidisciplinary teams
* Experience level should be within the range of moderate experience and competency in late stage drug development submissions to extensive experience and skill in crafting expert integrated nonclinical risk assessments and working directly with regulatory agencies and industry consortia on the regulations governing nonclinical pharmaceutical development
* Expectations include a working knowledge of international regulatory guidelines and practices, demonstrated ability to author regulatory documents of high quality, appropriate decision making regarding drug candidate development and in effectively communicating a drug regulatory strategy, ability to communicate well across business lines, and effective participation in teams of diverse expertise NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS: Limited travel will be required, e.g., to attend meetings with global regulatory agencies, and occasional face-to-face meetings at different Pfizer sites.

EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.