ROLE SUMMARY To develop clinical development plan from first in human clinical trial to proof-of-concept, including assessment of appropriate combinations, as well as evaluation of potential predictive and pharmacodynamics biomarker plans To work collaboratively with the functional groups within Oncology Clinical Development. To ensure the clinical components of the clinical plans and clinical expertise are provided to project teams, including medical monitoring of clinical trials.\u00a0 To support projects from Research to Proof of Concept (typically phase 2) at which point molecule may be handed to the Oncology Global Product Development for post-POC (typically phase 3) development. A major focus of the group is on new generation immunotherapies from naked immune monoclonal antibody to cell-based therapy. To provide and utilize innovative methods to integrate knowledge, patient characteristics and diseases for rational development strategies and decisions. ROLE RESPONSIBILITIES Provides leadership to the clinical function for preparation of critical documents, including but not limited to clinical protocol, clinical development plan, investigator brochure, statistical analysis plan, and regulatory documents. He\/she will closely work in a matrix team environment, including other clinicians, statisticians, clinical pharmacologists, translational biologists and others at an international level. The candidate will work on at least two clinical projects and will support the development and provide consultation regarding multiple research projects. Provide administrative and technical oversight of clinical function within his\/her Group Ensure that all activities are conducted in compliance with relevant regulatory requirements. Monitor and report on implementation of Global clinical initiatives in his\/her group Develop charters, resource utilization and project plans to achieve clinical project -specific goals Implement site organizational design and develop succession planning for clinical area. Develop people, including recruitment, retention, and career development as directed by Oncology Clinical Development Head. Ensures development of and adherence to Safety Review Plan (SRP). Consistent with SRP, performs regular review of individual subject safety data, and performs review of cumulative safety data with the safety risk lead or as delegated by the clinical leader. As appropriate, the Senior Director may delegate these responsibilities to a physician study clinician identified in the SRP. Be accountable for clinical analyses, programmed outputs, and integrated scientific reports for clinical trial results and support for publication activities, for assigned projects. Implement strategies to ensure that the clinicians are collaborative, strategic partners with scientific and clinical colleagues. Implement strategies to ensure appropriate consistent processes in strong collaboration with associated RU partners. Develop effective collaborations with Clinical Leads in Oncology Research & Development and Global Product Development organizations, and external regulatory, industry, professional and academic organizations. Provide a strong presence in regulatory and professional circles to influence content of regulatory guidelines and their interpretation in practice. Implement aligned strategies and consistent processes to optimize the use of corporate standards QUALIFICATIONS Requires MD\/PhD or MD and demonstrated depth and breadth of knowledge and experience in clinical research in the academic, clinical practice or industry setting. Prior specialized training in Medical Oncology; Board Certification in Oncology is desirable At least 3 or more years experience in the pharmaceutical industry with a track record in early phase drug development through to phase 2 Proof of Concept. Experience in the development of Immuno-therapeutics in Oncology Understanding of related disciplines (e.g. biostatistics, regulatory, pre-clinical pharmacology, pharmaceutical sciences).\u00a0 Demonstrated scientific productivity (publications, abstracts, etc.) Proven scientific writing skills and good communication skills Proven leadership skills with ability to defend the clinical plan at governance meetings is essential Capacity to adapt to a fast-paced and changing environment 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. 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\u2019s 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. Eligible for Relocation Package Eligible for Employee Referral Bonus Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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