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Drug Safety R&D, Therapeutic Area Lead

Pfizer


Location:
Cambridge Kendall Sq. 700 Main, MA
Date:
09/19/2017
2017-09-192017-10-18
Job Code:
1610694
Pfizer
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Job Details

Job Title Drug Safety R&D, Therapeutic Area Lead

JobID 1610694

Location: Cambridge Kendall Sq. 700 Main, MA

Description The DSRD TAL is accountable for development and implementation of the safety and risk management strategy for within-TA (note: TA is used synonymously with RU in this document) projects from Idea to Loss of Exclusivity (LoE), ensuring that strategy is aligned with the overall objectives of the TA, and enabling those TA goals to be met. In addition, as a member of TA-specific governance bodies, the TAL is expected to fully engage such that they contribute expertise to all aspects of programs within the TA. The TAL ensures provision of DSRD expertise within TA for assessment of potential licensing or acquisition deals, including where necessary, identification of resources to participate on due-diligence teams. Through a matrix or hard-line reporting relationship, the TAL will provide ongoing guidance and mentorship to within-TA drug safety team leads from Idea to LOE.



Through active external surveillance, consultation with external key opinion leaders, and collaboration with internal subject matter experts, TAL drives organizational and regulatory acceptance of innovative scientific approaches, biomarker strategies and regulatory packages to accelerate portfolio deliverables.



Major Responsibilities



+ Perform all regulatory responsibilities in compliance with applicable regulatory standards

+ Management of Drug Safety Team Leads (DSTLs) and/or other DSRD portfolio staff such as Licensing and Acquisition leads. These may be hard-line (direct reports) or dotted-line (matrix) management relationships. .

+ Drives organizational and regulatory acceptance of innovative scientific approaches, biomarker strategies and regulatory packages to accelerate portfolio deliverables in close collaboration with the Research, Regulatory, and Clinical Lines.

+ Assures that expedited packages are achieved through active external surveillance, consultation with external key opinion leaders, and collaboration with internal subject matter experts.

+ As the Drug Safety representative to the TA specific bodies (such as TA-Technical Review Committee), provides strategic direction, scientific expertise, and resource prioritization and is accountable for delivery of the Drug Safety component of the TA from Idea to LoE.

+ Point of accountability for the development and delivery of comprehensive programmatic safety strategies developed by Drug Safety Team Leads to ensure rapid progression through Research and Development.

+ Oversees development, and approve implementation of biomarker and risk management strategies developed by Drug Safety Team Leads to ensure progression of compounds and programs within TA.

+ Review and endorse Issues Management Plans in consultation with Global Portfolio Safety Review Committee (GPSRC).

+ Ensures that the DSRD strategy specific to that TA is aligned with Program objectives and priorities.

+ Matrix or hard-line management of Drug Safety Team Leads (DSTLs).

+ Responsible for within-TA prioritization of projects and/or project related activities, to guide resourcing decisions within DSRD.

+ Provides or ensures provision of DSRD expertise within TA for assessment of potential licensing or acquisition deals, including participation on assessment teams as required.

+ Accountable for DSRD line activities and resources supporting safety strategies in TA from Idea to LoE, including line review and technical quality of toxicology deliverables.

+ Oversees the review and approval of toxicology plans, and endorse any needed exceptions to standard protocols.

+ Reviews and endorses DSRD components of stage gate documentation, including CAN documents, Nonclinical Overviews (NCOs), Investigator Brochures (IBs), etc... through global registration.

+ Ensures that study reports and regulatory submission documents are consistent in their interpretation and are aligned with risk management strategies.

+ Review and endorsement of regulatory responses and participation in Regulatory Agency interactions, as required.

+ Final approval of the use of within-TA compounds in studies which employ toxicologically-relevant doses and/or are intended to assess safety.



Qualifications -



+ Ph.D.,or D.V.M., or M.D., and equivalent experience

+ Demonstrated expertise in drug discovery and development.

+ Demonstrated ability to work collaboratively, lead, and manage in a matrixed, multi-line environment.



**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.



**Sunshine Act**

Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.



**Additional Offer Details:**



+ **Last Date to Apply for Job:** October 15, 2017

+ **This job is (Pfizer) (Exempt) (US/PR)** Grade: 018

+ Eligible for Relocation Package: yesEligible for Employee Referral Bonus: yes



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 bio-pharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.



Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.


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