Category Clinician (MD), CGRP Migraine Franchise (Senior Director)

Category Clinician (MD), CGRP Migraine Franchise (Senior Director)

ROLE SUMMARY

The Category Clinician supports the Global Clinical Lead (GCL) in the development and execution of the Clinical Development Plan and associated protocol design documents (PDDs). The primary responsibility of this Category Clinician role is to support the pediatric programs for the CGRP Migraine Franchise including rimegepant (Nurtec ODT/Vydura) and zavegepant (Zavzpret nasal spray). These programs consist of post-approval, potentially indication-seeking trials for acute treatment of migraine, episodic migraine prevention, and chronic migraine prevention in accordance with agreed the investigational pediatric study plans (iPSPs), pediatric investigational plans (PIPs), and pediatric written requests (PWRs). Key deliverables include the design of the global pediatric development program, oversight of pediatric program execution, and leading global regulatory interactions and eventual submissions for the pediatric indications for both assets, in collaboration with the GCL. The individual will work closely with the CGRP franchise GCL for the migraine program ensuring the CGRP assets can provide meaningful clinical benefit to patient care across the age spectrum impacted by migraine. This position reports directly to the Medicine Team Lead (MTL) for Business Development and E2E Planning and has a matrix reporting relationship to the MTL for the CGRP franchise.

For the pediatric migraine indications for the CGRP franchise, the individual will work collaboratively with the Clinical Development Team including but not limited to clinical, clinical pharmacology, statistics, safety and operations colleagues in the design, execution and interpretation of pediatric studies in support of worldwide regulatory submissions. The individual may lead a sub-team of the Clinical Development Team that is focused on clinical pediatric deliverables. Working with the GCL, the individual will be responsible for creating the Clinical Development Plan and associated protocol design documents in support of assigned indications.

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 medical 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 may provide 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 may support due diligence activities on potential in-licensing opportunities.

As a pediatric development expert, s/he may provide advice and guidance on other Pfizer pediatric clinical development programs, in collaboration with the Pediatric Center of Excellence.

ROLE RESPONSIBILITIES

• Partners effectively with the Medicine Team Lead and Global Clinical Lead for the CGRP migraine franchise to negotiate tradeoffs, milestones and ensure delivery of the clinical program in line with agreed timelines and budget.
  
• Supports development of the CDP with specific responsibility for all pediatric studies, pediatric study plans (PIP/PSP).
  
• Creates and obtains endorsement for the CDP in support of assigned indications and in collaboration with the GCL for the migraine program.
  
• Responsible for comprehensive clinical development plans to secure acceptance of the Nurtec/Vydura and Zavzpret pediatric development programs globally along with creating and/or updating the PIP/PSP/PPSRs and associated protocol design documents (PDD's) working closely with the Clinical Triad as well as CD&O clinicians to ensure study feasibility and optimized operational execution.
  
• Provides product/program specific input for target product profile(s)
  
• Willingness to bring innovative thinking and bold decision making across clinical development programs and individual studies.
  
• Develops specific clinical development enabling strategies including digital/ innovation and patient engagement approaches.
  
• Partners with CD&O clinician on governance reviews (incl Sci/Ops) for assigned clinical studies. Provides category clinical development strategy input and insights to 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 as required.
  
• Provides specialized medical monitoring support for study team, if required
  
• Key partner in study level SAP, TLFs, BDRs in partnership with statistics and programing
  
• Develops submission level deliverables (IAP, IARP and submission TLFs). Responsible for submission deliverables including SCE and SCS
  
• Support appropriate interpretation and communication of clinical trial data.
  
• Review and approve submission level safety narrative plan.
  
• Supports product label development and maintenance.
  
• Engage key external stakeholders e.g., Ad boards, Steering Committees, 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 (DSUR, PBRER) submission disclosure deliverables and product defense.
  
• Represents clinical development for health authority engagements or requests for information related to the CGRP pediatric development programs.
  
• Ensures compliance with internal SOPs and external regulatory standards.
  
• Review IIR proposals.
  

BASIC QUALIFICATIONS

• MD (or equivalent)
  

PREFERRED QUALIFICATIONS

Experience

• Pediatrician with drug development experience in pediatric clinical development. Experience with pediatric acute treatment of migraine and migraine prevention trials strongly preferred.
  
• 7+ years of relevant experience and track record of success in academia and/or the biopharmaceutical industry in clinical research and development.
  
• Extensive knowledge of pediatric clinical development, global and regional regulation, ICH/GCP, adverse event management and experience in global regulatory submissions
  
• 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 teams in clinical development.
  
• Demonstrated experience in designing and launching large teams preferred.
  

Competency Requirements

• 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 work in a highly complex matrixed environment and able to influence cross-functional teams.
  
• 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.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Global travel may be required.

#LI-PFE

#LI-REMOTE

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The annual base salary for this position ranges from $246,400.00 to $410,600.00. In addition, this position offers an annual bonus with a target of 25.0% of the base salary and eligibility to participate in our share based long term incentive program. Benefits offered include a retirement savings plan, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans. Salary range does not apply to the Tampa, FL location.

Relocation assistance may be available based on business needs and/or eligibility.

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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.

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EEO & Employment Eligibility

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