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The Submission Clinician will work within the Submissions Teams for one or more assets being developed in the company Biosimilars programs. This individual will work across multiple clinical disciplines. This role is considered that of a specialized GCL or Clinician at the company and under the direction of the GCL for Submissions and has the following responsibilities:
• Contributes to the clinical narrative and the clinical data in Module 2 in order to support the Totality of Evidence and extrapolation messages for Biosimilars working with regulatory, asset team, and functional leads (e.g. the PGS Co-Development Leads and non-clinical leads).
• Supports the regulatory and asset team in developing the messages on clinical aspects of the program, feeding in to the strategic totality of data story.
• Confirms all technical clinical trial data interpretation, working with the GCL and Clinical triad- Clinical Pharmacology, Statistician and Clinician, when defining the data analyses for the Clinical Study Report (CSR)
• Develops the scientific content for the development of the Clinical sections of the Risk Management Plan for the program working with the Global Clinical Lead (GCL) and the Safety Risk Lead (SRL)
• Shares accountability with regulatory for clinical aspects of scientific content for discussions with Regulators and for the resolution of queries from drug regulatory agencies / ethics committees; contributes to writing and reviewing responses to regulatory queries.
• Shares accountability with the GCL in obtaining endorsement, agreement and alignment of clinical interpretation of the results presented to governance, external consultants, KOLs, and Regulatory meetings as needed
• Accountable for governance alignment and agreement of the clinical package for Common Technical Document (CTD) submissions
• The Submission Clinician will report to GCL - Biosimilars Submissions and will work within and across the teams to support biosimilar asset(s)
• Responsible together with the Clinical GCL and the Lead Writer for the technical content, flow and documentation of the Clinical sections of the submissions for assets in the company Biosimilars programs
• Shares responsibility together with regulatory, medical writer, the GCL and all other relevant functional lines in providing the clinical contribution to the cross functional extrapolation strategy and final narrative
• Responsible for obtaining from the GCL and the asset team the key information required from all studies from Phase 1 through Phase 3 to support registration, working with each program's GCL and cross-functional Clinical study teams
• Responsible for the clinical data analyses and interpretation of clinical components for submission packages for all Regulatory agencies
• Responsible for obtaining governance agreement and alignment of the final interpretation of all clinical data from the clinical trials plus data from the innovator from publications and ad-hoc studies including meta-analyses in support of the registration of each asset
• Responsible for the identification of additional studies and data review, analysis and interpretation as needed (epidemiology, originator's meta-analyses, etc.) for the extrapolation arguments
• Responsible with Medical Writer for the clinical sections of the global submissions: background information, data analyses and interpretation and supportive clinical information for all regulatory agencies
• Ensures compliance with global and local training requirements and adherence to relevant global / local SOPs
Training, Education and Experience:
• Requires MD and previous experience as a clinical lead in drug development.
• Experience: 5+ years of experience in pharmaceutical industry as a clinician in drug development, 3+ years of experience in submission work of new drugs or biological agents required (preferably at the company)
• Experience in Biosimilars preferred
• Understanding of related disciplines (e.g. biostatistics, regulatory, pharmacology, pharmaceutical sciences, understanding of the eCTD guidance).
• Experience with global regulatory submissions, including clinical CTD components, briefing documents, query responses, interactions with regulatory agencies, etc
• Understanding of clinical submission requirements.
• Ability to work in new and multiple therapeutic areas.
• Proven scientific writing skills and good communication, and collaborative problem solving skills.
Other Information - Internal
Colleagues who are issued an Incident Final Warning (IFW) on or after January 1, 2016, are not eligible to post and compete for a position for a period of 12-months from the date an IFW is issued.
EEO & Employment Eligibility
the company 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. the company 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. the company is an E-Verify employer.
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