The Category Clinician supports the Global Clinical Lead in the development of the Clinical Development Plan and associated protocol design documents (PDDs). S/He partners closely with colleagues in other lines to ensure program feasibility and optimized operational planning 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 advanced scientific knowledge and 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 as needed, including support of protocol interpretation, data review and signal analysis/evaluation. S/He may provide specialized monitoring support if required. S/He will support the GCL on regulatory submissions and is a key clinical contributor/author for submission deliverables including the SCE, SCS and clinical overview. The Category Clinician will support various regulatory activities including product labels, core data sheets, Investigator Brochures, Development Safety Update Reports, Periodic Benefit-Risk Evaluation Reports, and will provide clinical input to Label as Driver deliverables. In addition, the Category Clinician provides input for target product profile(s), and other critical deliverables used in decision making and aligning CDP to Commercial and Access/Reimbursement goals. 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 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.Education
- 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 and patient engagement approaches.
- Support GCL in leading preparation for engagement points for CDP with governance and incorporation of feedback from such interactions into final deliverables.
- 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.
- Partners with Safety Risk Lead to contribute to benefit-risk analysis though participation in core safety working groups and benefit risk committees, as required
- Key partner instudy level SAP, TLFs, BDRsin partnership with statistics and programing
- May support GCL on submission level deliverables (IAP, IARP and submission TLFs). Key clinical contributor for submission deliverables including SCE, ISE, ISS, and SCS
- As a key contributor to the CSR and external presentations and/or manuscripts, supports 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, including clinical input to Label as Driver deliverables
- Provides product/program specific input for targetproduct profile(s), medicine differentiation indicator, and other Robust Decision Making deliverables
- Supports 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 ISR proposals (in partnership with GCL)
- Advanced degree or professional certification in a health care related, scientific or technical discipline required
- 10 years of experience and track record of success in biopharmaceutical industry in clinical research and development, to include Phase 2b/3 development experience
- 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 guiding large cross-functional teams in clinical development
- Demonstrated experience in organizing and launching large teams preferred
- Demonstrated experience with global regulatory submissions (e.g., NDA, BLA, MAA) preferred
Other Job Details:
- 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 pertinent to clinical development planning and execution
- Management experience -Able to work in a highly complex matrixed environment and able to influence cross-functional teams
- Leadership -Persuasive and effective leader of staff in a matrixed team setting
- 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
- Recognizing and Developing Talent -Good judge of talent; can articulate strengths and limitations of people; provides challenging tasks and assignments, holds frequent development discussions; is aware of each person's career goals and constructs compelling development plans; is a people builder.
- 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
- Eligible for a Relocation Package
- Eligible for Employee Referral Bonus
- Additional Location Information: United States-Pennsylvania-Collegeville, United States-New York-New York, United States-Connecticut-Groton, United States-Massachusetts-Cambridge, Milan-Italy; Virtual location, Any Pfizer Site
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