• Job Description

  Req#: 4889431

  ROLE SUMMARY

  The Oncology Clinical Lead 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 Oncology Clinical Lead acts as 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 Oncology Clinical Lead 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 Oncology Clinical Lead 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

  • 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 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 partner in study level SAP, TLFs, BDRs in 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 product/program specific input for target product profile(s), clinical due diligence activities on potential in- licensing, or partnership opportunities as delegated by the GCL.
  • Engage key external stakeholders with GCL 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 (incl IB, DSUR, PBRER) in partnership with the GCL, submission disclosure deliverables and product defense.
  • Review IIR proposals (in partnership with GCL).

  BASIC QUALIFICATIONS

  Education

  • MD (or equivalent)

  PREFERRED QUALIFICATIONS

  Experience

  • 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.

  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 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.

  #LI-PFE

  #LI-Remote

  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. Pfizer compensation structures and benefit packages are aligned locally, the US Salary range provided does not apply to the Tampa, FL or any EXUS locations.

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

  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.

  Medical

• About the company

  At Pfizer we know that great things happen anywhere people come together with one shared goal. And the greatest rewards are sometimes where you least expect them. The future of medicine is happening at Pfizer.

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