Senior Director, Clinical Oncology (MD required)

ROLE SUMMARY

In addition to primary responsibility as a global clinical lead (GCL), this role requires: (1) subject matter expertise in oncology patient medical care derived from recent, direct oncology patient care in a clinical setting; (2) experience and ability to serve as primary liason between Pfizer Boulder R&D and Oncology R&D during and after Boulder R&D externalization; and (3) recent, direct work experience as both a GCL and a Program Lead (PL, also known as asset team lead (ATL).

• Single point of contact and consultant for ORD for individual patient clinical care issues across all Pfizer early oncology clinical trials
• Brings modern, up-to-date patient care procedures and methodologies to all of Pfizer's early phase clinical trial protocols and trials.
• Develops training/retraining/educational process for ORD GCLs and ECD study clinicians (SCs) regarding r acute oncologic emergencies and care of treatment-refractory oncology patients enrolled to phase 1 clinical trials
• Develops real world evidence approaches to Phase I clinical trial benchmarks and novel clinical endpoints
• Liaison from ORD/EODCR liaison to Worldwide Medical and Safety
• Sufficient knowledge of entire Pfizer early oncology portfolio (e.g., across ORD and Boulder R&D), and therefore capable of managing programs in either portfolio and liaising between sites
• Direct experience managing small molecule targeted inhibitor early clinical trials as GCL and PL.
• Ensures the clinical components of the clinical plans and clinical expertise are provided to project teams, including medical monitoring of clinical trials
• Provides and utilizes innovative methods to integrate knowledge, patient characteristics and diseases for rational development strategies and decisions
• Develops clinical development plan from first in human clinical trials to proof-of-concept, including assessment of appropriate combinations, as well as evaluation of potential predictive and pharmacodynamics biomarker plans
• Works collaboratively with the functional groups within Oncology Clinical Development
• Supports 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

ROLE RESPONSIBILITIES

• Unique to this role: clinical oncology care subject matter expert within ORD/EODCR, and Boulder R&D-ORD liaison
• Serves as single point of contact for clinical care questions and issues that emerge for individual patients treated on early oncology clinical trials
• Develops, implements and regularly updates training/retraining/educational forum for the clinical care of complex medical oncology patients, to include review of acute oncologic emergencies and common medial issues experienced by early phase oncology patients
• Partners with Worldwide Medical and Safety to review and improve SOPs related to early clinical trial monitoring, reporting of (S)AEs, and periodic individual program and cross-program review of safety across trials.
• Familiarity with Boulder RU portfolio and key stakeholders and able to facilitate Boulder RU externalization.
• Direct experience as global clinical lead (GCL) and program lead (PL)
• Common to others with this role: serves as Global Clinical Lead (GClL on at least two clinical-stage projects, several preclinical-stage projects, and several business development diligence opportunities. Related to these:
• 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.
• Works closely in a matrix team environment, including other clinicians, statisticians, clinical pharmacologists, translational biologists and others at an international level.
• 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.
• Implements site organizational design and develop succession planning for clinical area.
• 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.
• Accountable for clinical analyses, programmed outputs, and integrated scientific reports for clinical trial results and support for publication activities, for assigned projects.
• Implements strategies to ensure appropriate consistent processes in strong collaboration with associated RU partners.
• Develops effective collaborations with Clinical Leads in Oncology Research & Development and Global Product Development organizations, and external regulatory, industry, professional and academic organizations.
• Provides 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.

BASIC QUALIFICATIONS

• MD (+/- PhD) in internal medicine
• Successful completion of fellowship in medical oncology +/- hematology
• Current board certification in Medical Oncology
• Current license to practice medicine
• Currently practices the equivalent of at least one week per month in the outpatient or inpatient medical oncology setting and has done so for last ten years continuously.
• Served in capacity of GCL and PL in the last 2 years in the pharmaceutical industry with a track record in early phase drug development
• Understanding of related disciplines (e.g., biostatistics, regulatory, pre-clinical pharmacology, pharmaceutical sciences)
• Proven scientific writing skills and good communication skills
• Proven leadership skills with ability to defend the clinical plan at governance meetings is essential
• Proven capacity to adapt to a fast-paced and changing environment
• Oncology patient clinical care deep knowledge and expertise

PREFERRED QUALIFICATIONS

• Demonstrated scientific productivity (publications, abstracts, etc.) is desirable.

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.

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.

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.

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