Job description
Category Clinician (MD)
ROLE SUMMARY
The Category Clinician supports the Global Clinical Lead (GCL) in the development and execution of the Clinical Development Plan (CDP). 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.
ROLE RESPONSIBILITIES
- Support development of CDP including pediatric plans (PIP/PSP) and associated protocol design documents (PDD’s) working closely with CD&O clinicians to ensure study feasibility and optimized operational execution.
- Lead initiatives and teams in support of delivering on CDP objectives.
- Develop medicine specific clinical development enabling strategies including digital / innovation and patient engagement approaches.
- Support GCL in leading engagement points for CDP with governance.
- Partner with CD&O clinician on governance reviews for assigned clinical studies with GCL support.
- Provides category clinical development strategy input and insights to Clinical Development and Operations (CD&O) clinicians for assigned clinical studies.
- Provides therapy area / indication expertise in support of CD&O clinical review of clinical data – including CRF design, assistance in signal interpretation, contextualizing adverse events etc. as required.
- Provides specialized medical monitoring support for study team if required
- Key contributor to and reviewer of study level statistical analysis plan, tables listings and figures (TLFs), blinded data review BDRs in partnership with statistics and programing
- Support GCL on submission level deliverables (IAP, IARP and submission TLFs). Key clinical contributor for submission deliverables including summaries of clinical efficacy and safety (SCE, SCS) and Clinical Overview.
- 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 product/program specific input for target product profile(s), clinical due diligence activities on potential inlicensing, or partnership opportunities as delegated by the GCL
- Engage key external stakeholders with GCL e.g advisory boards, Steering Committees, Data Monitoring Committee (DMC), Adjudication Committees, patients and patient advocates and other external stakeholders, to drive strategic insight generation to support clinical development strategy and PDD development.
- Provides regulatory submission support (incl investigator brochure, DSUR, PBRER) in partnership with the GCL, submission disclosure deliverables and product defense.
- Review investigator sponsored research (ISR) proposals (in partnership with GCL)
BASIC QUALIFICATIONS
Education
- MD (or equivalent )
PREFERRED QUALIFICATIONS
Experience
- 10 years of experience 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
- Regulatory filing experience preferred
Competency Requirements
- Medical / Scientific credibility/Excellence - Record ofachievement 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 work in a highly complex matrixed environment and able to influence cross-functional teams.
- Leadership - Persuasive and effective leader of colleagues in a matrix environment
- 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.
PHYSICAL/MENTAL REQUIREMENTS
Ability to perform complex data analysis.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Global travel required.
#LI-PFE
Relocation assistance may be available based on business needs and/or eligibility.
Pfizer 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
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.
EEO & Employment Eligibility
Pfizer 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. Pfizer 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. Pfizer is an E-Verify employer.
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