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Pfizer Inc. Colorectal Cancer Melanoma Global Clinical Lead in Denver, Colorado

Role SummaryThis position will be responsible for vision strategy in colorectalcancer/melanoma and will lead agents within Oncology Clinical Developmentproviding strategic and technical guidance, as well as coordination andsupport to Medical Monitors and non-MD clinicians in CDandO.Provides therapeutic area clinical expertise to a project(s) and maintainsstate of the art knowledge in Therapeutic Area.Provides oncology expertise to the project team to enable clinicalinterpretation of study data.Role ResponsibilitiesProvide Clinical Development Leadership to Asset Teams:Technical:Scientific Expertise and Recognition: high impact publications, keyexternal presentations, recognized as subject matter expert internally andsought out for advice.Contribution to Projects:Accountable to deliver 2 or 3 large studies - related to execution and abilityto bring in time lines.Single point of contact for Clinical Development to Medicine Team Leader forone or more indications or assetChairs the Clinical Sub-Team.Leads design, implementation, and interpretation of part of the globalclinical program (one or more indications) for a drug candidate to delivera successful regulatory submission worldwide, working closely with theClinical Development Leader.Ensures alignment of regional clinical development strategy with globalstrategies for the indications he or she is responsible for.Contributes to development strategy, by creating and updating the clinicaldevelopment plan which should integrate well-designed studies with the mostefficient use of budget and resources, and risk and quality assessment.Leads the preparations of the clinical content of regulatorysubmissions/documents (e.g. NDA, MAA, IND, sNDA, IB,AR/DSRU, label changes, Core Data Sheet, Package Insert) undersupervision of the Clinical Development Leader.Signs off clinical documents as required by internal Guidances/SOPs.Leads discussions with regulators and with the resolution of clinical queriesfrom drug regulatory agencies; leads or contributes to writing and reviewresponses to regulatory queries.Provides clinical input in the preparation and execution of meetings withhealth authorities.Maintains and enhances knowledge in relevant therapeutic or technical areasand in global regulations/guidelines.Provides clinical strategy/input to product teams to support marketing andproduct enhancement/ differentiations efforts, as needed.Maintains state of the art knowledge in the tumor-specific therapeutic area.Creates and maintains a network with key opinion leaders.May organize expert panel, consultant or advisory board meetings to provideinput to clinical plans.May be an active member of an alliance partnership team.May present to senior management, governance committees and externalaudiences on the clinical aspects of compound development, includingmilestones, strategies and data, as appropriate.Supports licensing initiatives, as appropriate, and as such maydesign/conduct/review protocols as a member of licensing team.Represents the Clinical line on the Publication Sub-Committee and contributesto designing the publication strategy for the asset(s).Represents the clinical line on project-related teams and cross-divisionalcommittees.Reviews ISR proposals.Interfaces with other Pfizer sites, other TAs and other functions to sharebest practices, as appropriate.Management:Mainly matrix management responsibilities.Involvement in business and teaching others around due diligence.Leadership attributes:Mentorship: track record of developing others; sought out by more juniorcolleagues as a mentor.Excellence in leadership within the GMT, leading the CMT and consistent withPfizer values.Leads cross- department initiatives(e.g., Research, Safety Sciences,CDandO, Commercial) to support development efforts as needed.Presentations to the TRIAD and GPDLT.Career maturity and growth supervisory role, role in business development.Significant degree of independence, willing to take on special projects;unique stud

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