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Senior Medical Director, Prostate Cancer

2 months ago


Cambridge, United States Pfizer Full time

The Senior Medical Director provides Clinical Development leadership and expertise on clinical trials directly and/or supervises other (associate) medical directors, including overseeing study design, conduct, and analysis. The senior medical director works closely with other functions such as clinical operations, biostatistics, pharmacovigilance, regulatory affairs, and medical affairs to ensure that the clinical development program meets scientific, ethical, and regulatory standards. The senior medical director also provides medical expertise and guidance to the clinical operations team, the investigators, and the external stakeholders such as health authorities, ethics committees, steering committees, independent data monitoring committees, and patient advocacy groups. This position will focus on the talazoparib development program in prostate cancer.

JOB RESPONSIBILITIES

Clinical Development Leadership on Study Teams and Development Subteams

  • Leads and contributes to development and maintenance of clinical trial and regulatory documents (e.g. protocol, amendments, case report forms, informed consent forms, investigator brochures, safety updates), in collaboration with the Clinical Scientist and the cross-functional team.

  • Assists in site selection as needed

  • Conducts medical monitoring activities including eligibility assessment, response to site queries, safety monitoring, and data review.

  • Leads peer-to-peer interactions with investigators.

  • Serves as the point of contact for clinical issues between the study team, investigators, ethics committees, steering committees, and regulatory authorities.

  • Provides clinical development leadership across several study teams as needed.

  • Serves as the Clinical Development Lead on subteams, including for Marketing Authorization Applications.

  • Contributes to abstracts, posters and manuscripts for publications.

Strategic Guidance, Clinical Insights & Interpretation

  • Collaborates with the Global Development Team to create and refine development strategies.

  • Represents the company in external engagements, including but not limited to joint collaborations.

  • Collaborates with the Clinical Scientist, Statistician, Statistical Programmer, and Data Manager to review and interpret clinical data, identify key findings and implications, and communicate to internal and external stakeholders.

  • Maintains a high level of clinical expertise and professional competence by staying abreast of the latest developments, literature, and guidelines to advise on and drive current and future clinical development plans.

  • 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.

QUALIFICATIONS / SKILLS

  • Medical degree (MD or DO)

  • 5+ years industry experience

  • Board certified/eligible in oncology or equivalent preferred

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Up to 10%

Work Location Assignment:Hybrid

#LI-PFE

The annual base salary for this position ranges from $253,800.00 to $423,000.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 25.0% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.

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.

Medical