The Category Clinician supports the Global Clinical Lead in the development of the Clinical Development Plan and associated protocol design documents. S/He partners closely with colleagues in other lines to ensure program feasibility and optimized operational execution and supports organization of expert panels and advisory board meetings to provide input into clinical plans, study design or data analysis.
The Category Clinician acts a key partner for other clinical and clinical operations colleagues through the study lifecycle. S/He provides therapeutic area expertise to the development of the final protocol and associated deliverables. During study execution and reporting the Category Clinician provides ongoing support to other clinical colleagues in support of data review and signal interpretation. S/He may provide specialized monitoring support if required.
S/He will support the GCL on regulatory submissions and is a key clinical contributor for submission deliverables including the SCE, SCS and clinical overview.
In addition the Category Clinician provides input for target product profile(s), due diligence activities on potential in-licensing opportunities and regulatory activities including product labels, core data sheets, Investigator Brochures, Development Safety Update Reports, Periodic Benefit-Risk Evaluation Reports.
S/He will help identify potential business development opportunities in his/her area of expertise and will support due diligence activities on potential in-licensing opportunities: S/He may lead the technical team activities in collaboration with Business Development.ROLE RESPONSIBILITIES
BASIC QUALIFICATIONS EducationPREFERRED QUALIFICATIONS
- Supports development of CDP including PIP / PSP and associated protocol design documents (PDD's) working closely with CD&O clinicians to ensure study feasibility and optimized operational execution.
- Develops medicine specific clinical development enabling strategies including digital / innovation.
- Support GCL in leading engagement points for CDP with governance.
- Partners with CD&O clinician on governance reviews (incl Sci/Ops) for assigned clinical studies with GCL support.Provides category clinical development strategy input and insights to CD&O clinicians for assigned clinical studies.
- Provides therapy area / indication expertise in support ofCD&O clinical review of clinical data - including CRF design, assistance in signal interpretation, contextualizingadverse events etc as required.
- Provides specialized medical monitoring support for study team if required
- Key partner instudy level SAP, TLFs, BDRsin partnership with statistics and programing
- Supports GCL on submission level deliverables (IAP, IARP and submission TLFs). Key clinical contributor for submission deliverables including SCE and SCS
- Support appropriate interpretation and communication of clinical trial data.
- Review and approve submission level safety narrative plan (in partnership with GCL)
- Supports product label development and maintenance
- Provides pproduct/program specific input for targetproduct profile(s), clinical due diligence activities on potential in- licensing, or partnership opportunitiesas delegated by the GCL
- Engage key external stakeholderswith GCL e.g. Ad boards, Steering Committees, DMC, Adjudication Committees, patients and patientadvocates and other external stakeholders, todrivestrategicinsightgeneration to support clinical development strategy and PDD development.
- Provides regulatory submission support (inclIB, DSUR, PBRER) in partnership with the GCL, submission disclosure deliverables andproduct defense.
- Review IIR proposals (in partnership with GCL)
- 10 years of experience and track record of success in biopharmaceutical industry in clinical research and development
- Extensive knowledge of clinical development, global and regional regulation, ICH/GCP, adverse event management
- Demonstrated clinical/medical, administrative, and project management capabilities, as well as effective verbal and written communication skills in relating to individuals both inside and outside Pfizer
- Demonstrated experience managing and training large teams in clinical development
- Demonstrated experience in designing and launching large teams preferred
- Medical / Scientific credibility/Excellence - Track record of achievement in pharmaceutical development, able to coordinate and execute clinical development or lifecycle strategy. Demonstrated understanding of the complexities and recent developments in the principal disease areas; confident discussing scientific / mechanistic aspects of drug development, also comfortable in discussing commercial and regulatory issues
- Management experience - Able to set priorities and manage cross-functional teams and complex projects to deliver milestones according to set budgets; sets priorities; able to define and manage appropriate resource requirements (budgets and FTEs) both in-house and vendors / contractors
- Leadership - Persuasive and effective leader of staff
- Influencing - Able to manage and motivate internal teams in clinical trials
- Conflict Management - Able to act as mentor / coach to others to improve conflict management skills; steps up to conflicts, seeing them as opportunities; reads situations quickly; can hammer out tough agreements and settle disputes equitably; prepared to take responsibility for a decision made and support this, even though it may be unpopular
- Team Building - Shares wins and success; fosters open dialogue; lets people finish and be responsible for their work; defines success in terms of the whole team; creates strong morale and spirit in his/her team; creates a feeling of belonging to the team
- Accountability - Take personal responsibility for results, pushing self and others to exceed goals and deliver results
- Change agile - Able to demonstrate perspective and poise in the face of uncertainty and effectively get things done amidst organizational change
- Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
Flexibility in working with other timezones.
#LI-RemotePfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.Sunshine Act
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