Posted:
10/10/2024, 11:11:34 AM
Location(s):
Connecticut, United States ⋅ Louisiana, United States ⋅ New York, United States ⋅ Massachusetts, United States ⋅ California, United States ⋅ San Francisco, California, United States ⋅ Collegeville, Pennsylvania, United States ⋅ Washington, United States ⋅ New York, New York, United States ⋅ Pennsylvania, United States ⋅ Bothell, Washington, United States ⋅ Cambridge, Massachusetts, United States
Experience Level(s):
Senior
Field(s):
Medical, Clinical & Veterinary
ROLE SUMMARY:
The Global Development Lead is responsible for defining and executing on the development strategy of a drug or molecule. The Global Development Lead works across the organization and on the cross-functional Global Development Team to lead, develop and execute the clinical development plan of CDK4.
ROLE RESPONSIBILITIES:
• Lead product specific Global Development Team
• Serves as the subject matter expert on clinical issues
• Work across the organization and on the cross-functional Global Development Team to lead, develop and execute the clinical development plan of a drug or molecule in alignment with the Lifecycle Management Plan and Integrated Product Plan
• Endorses clinical decisions in advance of GPT, senior management reviews or governance bodies
• Provide oversight and management responsibilities of medical director(s)
• Accountable for the clinical development strategy, trial design, execution, and delivery of trial results
• Accountable for integrating regulatory, statistical and other internal and external stakeholder input into study designs
• Serves as primary interface with Development Review Committee
• Oversee the development and management of clinical protocols and amendments, investigator brochures, and clinical study reports
• Oversee the evaluation, interpretation, reporting and presentation of study data
• Accountable with safety for clinical evaluations and safety decisions
• Accountable with clinical pharmacology for defining and identifying optimal dose and schedule selection
• Accountable with regulatory for health authority interactions
QUALIFICATIONS:
Medical degree or advanced degree with relevant clinical/industry experience (typically 4+ years).
• 7+ years industry experience
• 5+ years of experience leading diverse teams
• Prior management responsibilities of medical directors or clinical scientists
• Board certified/eligible in oncology or equivalent preferred
• Experience across multiple phases of clinical development and across drug classes in oncology
• Experience in leading NDA, BLA or MAA
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. This position requires permanent work authorization in the United States.
Website: https://www.pfizer.com/
Headquarter Location: New York, New York, United States
Employee Count: 10001+
Year Founded: 1849
IPO Status: Public
Last Funding Type: Post-IPO Debt
Industries: Biotechnology ⋅ Health Care ⋅ Medical ⋅ Pharmaceutical ⋅ Precision Medicine