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Associate Director Clinician (Neuro, Cardio/Metabo)

Pfizer


Location:
Cambridge, MA
Date:
12/02/2017
2017-12-022018-01-02
Pfizer
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Job Details

**ROLE SUMMARY**







+ The Clinician will be responsible for working collaboratively with the Clinical Lead and research project lead, physicians (medically qualified individual) and members of the research development team to plan and execute the clinical development plan for one or more compounds from lead development in discovery, through first in man (FIH), proof of mechanism (POM), early signals of efficacy (ESOE) and proof of concept (POC) studies (Phase 1-2 clinical trials).



+ The Clinician will actively participate in defining the key components for study design and writing clinical protocols, with input from team members from partner lines (statistics, clinical pharmacology, biology, operations, pharmaceutical sciences,...)



+ The Clinician will participate as an individual contributor on study teams with Clinical Operations and project team, to meet enrollment and study delivery timelines.



+ The Clinician will support the Clinical Lead on key strategic activities linked to Regulatory document updates







This role does not require the candidate be medically qualified.







**ROLE RESPONSIBILITIES**







+ Will contribute to or independently design protocols, amendments and conduct data review, analysis and interpretation.



+ Supports preparation of critical documents, including but not limited to clinical protocol, clinical development plan, investigator brochure, statistical analysis plan and regulatory documents.



+ Performs and documents regular review of individual subject safety data and performs review of cumulative safety data with safety risk lead or medically qualified individual.



+ Serves as a resource for clinical issues raised by internal and external collaborators, investigators, consultants and contractors



+ Supports and assists in the development of publications, abstracts, and presentations



+ Will author or QC clinical sections of regulatory documents (Investigator Brochure, Annual safety Reports/DSUR, IND sections, regulatory packages). Must have excellent scientific writing skills and communication skills.



+ Maintain up-to-date knowledge of scientific and clinical published literature in relevant therapeutic areas including the key clinical development issues.







**QUALIFICATIONS**







+ Graduate degree (PhD, PharmD, MSc equiv.) in life sciences and breadth of knowledge and experience in clinical research in the academic, or industry setting



+ Experience in Cardiovascular/Metabolic and/or Neurosciences preferred



+ 5 or more years of experience in Clinical Research



+ Familiarity with related disciplines (e.g. biostatistics, regulatory, pre-clinical pharmacology, pharmaceutical sciences).



+ Ability to analyze and interpret complex datasets.



+ Demonstrated writing and oral skills (regulatory documents, publications, presentation, etc.)



+ Strong interpersonal skills and expert team player with demonstrated ability to build consensus and drive change



+ Experience with clinician role preferred







Ability to operate with a sense of pace and urgency in matrixed project teams.







**ORGANIZATIONAL RELATIONSHIPS**







Collaborates with the study team(s) and partner lines by maintaining open communications between the two groups and ensuring successful program completion



Develop effective collaborations with key partner in the Internal Medicine Research Unit (IMRU), Early Clinical Development (ECD) organization, Clinical Operations, and other partner line in Worldwide Research & Development (WRD) organization.



Develop effective collaborations with project leads and projects team members, including ECD, statistics, regulatory affairs, clinical pharmacology and development operations.







**SUPERVISION**







Individual contributor no direct supervisory role.







**OTHER INFORMATION**



Relocation eligible



Eligible for employee referral bonus







**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.







**Other Job Details:**







+ Eligible for Relocation Package







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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