Senior Director - MD Breast Cancer Clinician - Pfizer - La Jolla

Job description
Role Description
Serves as a single point of accountability for design, clinical aspects of execution and
monitoring of oncology clinical protocols
* Accountable for design, clinical aspects of execution and safety monitoring of
individual studies
Responsible for:
* Driving scientific and technical excellence in the protocol team
* Collaborating as appropriate with other groups (e.g. Statistics, Clinical Pharmacology,
Health Outcomes, Safety and Risk Management, Regulatory Affairs, Project
Management, Pharmaceutical Science, Alliance Partners, Commercial)
* Responsible for ensuring input of global and local regulatory/medical standards into
clinical protocol.
* Assuring that the protocol(s) fits within the overall Clinical Plan for the asset and that it
clearly defines development milestones.

* Accountable for development of clinical documents (e.g., protocol, clinical study report,
clinical components of regulatory submissions.
Acquiring knowledge of competitor products and clinical plans.
* Assuring adequate medical oversight of studies, in particular for safety reviews, and
assessment of overall risk/benefit.
* Potentially supporting technical review of licensing opportunities, including due
diligence activities

Responsibilities
General
* Motivating and engaging colleagues in an understanding of disease understudy and
driving commitment and excitement around an indication and/or mechanism.
* Contributing to development strategy and updating of the Clinical Plan; contributing to
development of biomarker strategy in collaboration with Translation Oncology Lead (and
to Clinicians, if applicable); ensuring development of and adherence to, Safety Reporting
Plan.
Coaching and mentoring less experienced Clinicians as assigned.
* Maintaining and enhancing knowledge of relevant therapeutic or technical areas and of
global guidelines/regulations.
* Interfacing with other Pfizer colleagues and other functions to share best practices, as
appropriate.
* Providing clinical strategy/input to commercial matrix team to support marketing,
product enhancement/differentiation and launch planning, as needed.
* Supporting licensing initiatives, as appropriate, and as such may review/design
protocols or development plans as a member of a licensing team.
Contributing to regulatory documents (e.g., IB, IND Annual Report).
* Potentially organizing expert panels or consultant or advisory board meetings to provide
input into development plans, protocols or data analyses.
* Overseeing or conducting clinical biomarker validation activities, when relevant
* Potentially presenting to Asset Team management, governance committees or external
audiences on the clinical aspects of asset development, including milestones, strategies
and data, as appropriate.
Study Planning and Facilitation
* Accountable (with appropriate support) for design of the clinical study protocol
* Providing clinical input to protocol/study team for monitoring guidelines and analysis
plans, as needed (providing clinical leadership to the work of protocol/study team) .
* Collaborating with study management staff to identify, evaluate and select clinical sties
and investigators with appropriate technologies, models, biomarkers and/or health
outcome measures to improve characterization of drug candidates.
* Managing and/or initiating external collaborations to develop new methodologies and to
investigate mechanisms relevant to the therapeutic area.
* Collaborating with Alliance Partner for study enrollment and to support agreed
timelines for study deliverables.
Study Conduct and Monitoring
* Working with study team to identify and resolve medical problems.
* In close collaboration with Safety Risk Lead, tracking emerging efficacy and safety
profile of the asset. Keeping Asset Development Team informed of changes in the
efficacy/safety and/or risk/benefit profile as they occur
* Working with study team to ensure high quality of data, e.g. appropriate patient population, adequacy of clinical assessments etc., as study is ongoing.
* Must be fully knowledgeable about the safety profile of asset on which studies are being
conducted.
* Potentially serving as principal contact for Alliance Partners, study managers/monitors
and external collaborators and study sites on scientific and medical issues during conduct
of the trial
* Potentially initiating protocol amendments, as necessary, to address safety, efficacy or
recruitment issues
* Responsible for keeping Asset Clinical Lead informed of any critical clinical or
development issues, as appropriate
Study Analysis and Reporting
* Working with statistics and other clinical development staff (e.g.,Clinical
Pharmacology, Safety and Risk Management, Translational Oncology) in the review and
interpretation of data; accountable for overall quality and timeliness of analysis and
reporting
* Responsible for medical and scientific validity of Clinical Study Report, especially
conclusions regarding efficacy and safety. Responsible for disclosure of appropriate
safety and efficacy data and conclusions in PhRMA/ClinTrials.gov results database.
* Driving clinical interpretation of study data
* Leading or assisting in the development of publications (abstracts, manuscripts, slides,
etc) designated in the Publications Plan
Regulatory Interactions/Development of Regulatory Documents:
* Leading or assisting in the preparations of the clinical content of regulatory
submissions/documents (e.g. NDA, MAA, IND, sNDA, IB, AR)
* Leading or assisting in discussions with and resolution of queries from Regulatory
Agencies; leading or contributing to writing and review of responses to Regulatory
Agency queries.

Qualifications
MD Required
Five years of clinical development experience preferred.
Demonstrated technical, administrative, and project management capabilities are
required, as well as effective verbal and written communication skills and ability to relate
well to colleagues and associates both inside and outside the company

Preferred:
Prior oncology pharma experience
Postgraduate training/certification/fellowship in medical oncology and/or hematology
(both qualifications are an asset)
Demonstrated scientific productivity (e.g. publications, research reports, etc.)
Thorough understanding of local and international regulations applicable to clinical
development
Practical experience in clinical trial strategies, methods and processes
Track record of designing and interpreting excellent, focused development plans and
clinical studies
Experience with regulatory submissions is an asset

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