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Director, Study Clinician (Non

Pfizer


Location:
San Diego, CA
Date:
11/02/2017
2017-11-022017-12-03
Pfizer
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Job Details

+ The Clinician is responsible for working collaboratively with the members of the development team (including a medically qualified individual) to establish the clinical development plan(s) for one or more compounds from lead development in discovery to Phase I-II clinical trials, and for designing/executing and reporting protocols for studies included in the development plan.



+ This job role does not require individual to be medically qualified.



+ Depending on experience, may contribute to or be primarily responsible for formulation of clinical development plans. Contributes to or may independently design protocols, amendments and conduct data review, analysis and interpretation.



+ Consistent with Safety Review Plan, performs and documents regular review of individual subject safety data and performs review of cumulative safety data with the Safety Risk Lead or medically qualified individual. The specific components of safety data review are detailed in the Safety Data Review Guide - for Clinicians and SAF09 SOP (pharmacovigilance).



+ May contribute to or be primarily responsible for Go-No recommendations for the compound, including recommendation to advance to FIH after review of the preclinical package and involvement with transition and preparation to Phase III.



+ In conjunction with members of the development team may prepare strategy presentations, present and discuss data at relevant team, governance, external consultants, KOLs and potentially regulatory meetings as well as author clinical sections of regulatory documents (IB, Annual Reports, IND sections, CSR). Must have proven scientific writing skills and good communication skills.



+ Interface with discovery, safety sciences, statistics, PK/PD, marketing, regulatory, outcomes research, development operations, other members of the extended project team(s), internal governance, external experts and regulators.



+ In conjunction with study team is responsible for the on-time and within-budget execution of protocols.



+ May have functional responsibility for other clinicians assigned to the project and may supervise and develop other colleagues.



+ May act as clinical representative in in-licensing activities such as due diligence reviews and reports.



+ May transition early development clinical programs into late stage development.



+ Demonstrated experience with GCP and the ability to apply Pfizer policies and SOPs







+ Advanced scientific degree preferred (PhD, PharmD, MA); Degree in Life Sciences preferred. demonstrated experience in oncology drug development, early development preferred; familiarity with related disciplines (biostatistics, regulatory, pre-clinical pharmacology, pharmaceutical sciences); demonstrated scientific writing skills and good communication skills



+ 10+ years in clinical development



+ Some travel may be required







**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:**







+ **This job is (Pfizer) (Exempt) (US) Grade:** 16



+ Eligible for Relocation Package - YesEligible for Employee Referral Bonus - Yes







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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