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Senior Director, Therapeutic Area (TA) Clinician Lead Oncology (MD REQUIRED)


New York City, NY
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Job Details

Job Title Senior Director, Therapeutic Area (TA) Clinician Lead Oncology (MD REQUIRED)

JobID 1604816

Location: New York City, NY

Description The Therapeutic Area (TA) Clinician Lead will manage Study Clinicians to ensure high quality, cost efficient, and timely delivery of clinical programs.

He/She will work with the CD&O Clinical Group Leader to ensure appropriate resourcing of studies and other clinical projects including submissions. They will work with the Clinical Group Leader and relevant members of the study team to develop direct reports objectives, track progress and receive feedback on a regular basis. Depending on the TA, the TA Clinician Lead will provide line management of 6-10 TA Clinicians.

He/She will ensure that Clinicians within their group are well trained and compliant with requirements and regulations. He/She will develop the existing clinical staff and recruit additional clinical staff where needed. The TA Clinician Lead will be responsible for ensuring appropriate study design, protocol development and protocol clinical and medical oversight of the studies within the assigned group according to the relevant SOPs for clinical development responsibilities.

In collaboration and under the direction of the CD&O Clinical Group Leader, he/she will provide day to day oversight to ensure the progress of clinical studies in accordance with agreed clinical development plans and OpCo endorsed timelines. He/She will mentor and coach TA Clinicians on best practices and build the clinical expertise in their group.

The TA Clinician Lead is accountable for the medical & scientific integrity of the studies within their assigned portfolio and the well-being of the patients enrolled.

He/She are responsible for effective medical/scientific oversight of studies (in partnership with Clinical Scientists and Clinical Operations team members) and supports appropriate interpretation and communication of clinical trial data including high quality regulatory submissions and product defense activities. The TA Clinician Lead safeguards compliance with internal and external standards, proactively mitigates risk and manages emerging clinical issues.

Through their leadership of a group of clinicians, the TA Clinician Lead also supports the Global Clinical Lead in the Clinical Development strategy and supports the organization of expert panels and advisory board meetings to provide input into clinical plans, study design or data analysis.

Role Responsibilities

+ Manage Study Clinicians to ensure high quality, cost efficient, and timely delivery of clinical programs.

+ Work with the CD&O Clinical Group Leader to ensure appropriate resourcing of studies and other clinical projects including submissions.

+ Mentor and coach TA Clinicians on best practices and build the clinical expertise in their group.

+ Oversees and supports development of study outline and/or key protocol elements and proactively ensures efficient protocols that minimize the likelihood of amendments in a Therapeutic Area

+ At the asset level, may assist the Global Clinical Lead in the Clinical Development strategy and support technical review of licensing opportunities

+ Supports establishment of Data Monitoring Committees (DMCs) and endpoint adjudication committees, including chartering, contracts, provision of relevant data and documentation of outcomes

+ Oversees review and approval of Case Report Forms (CRFs) and Informed Consent Documents (ICDs), and selection and implementation of Patient Reported Outcomes (PROs)

+ Oversees review and approval of Integrated Quality Management Plan (IQMP) and Risk Management, Safety Review and Data Review Plans

+ Oversees review and approval of country selection, site selection criteria, and protocol specific training

+ Oversee the integrity of clinical & scientific aspects during clinical study conduct, analysis and reporting.

+ Consistent with the Safety Review Plan, oversees regular review of individual subject safety data and cumulative safety data with the Safety Lead

+ For all studies, ensures clinical safety reviews are performed in consultation with the designated Medical Monitor

+ Oversees identification of quality issues and review with Pfizer clinical/operations study team members so corrective actions may be instituted.

+ Responsible to oversee clinical and scientific validity of study report, especially conclusions regarding efficacy and safety

+ Responsible to oversee disclosure of appropriate safety and efficacy data and conclusions and contributions to primary publication of clinical trial results

+ Oversees review and management of protocol deviations and approval of protocol amendments

+ Ensures that clinical documents are updated and current in accordance with protocol changes or issues arising in the study

+ Assist responsible colleagues with the development of the Investigator Brochure (IB), key safety documents, responses to regulatory queries and audit/inspection findings, Clinical Trial Applications (CTAs), and submission documents by providing relevant clinical support.

+ Create career development plans with their report and finalize after discussion with Clinical Group Leader (CGL).

+ Justify and recommend business-related travel for reports to the CGL for their approval

Provide medical monitoring coverage when appropriate.

Basic Qualifications

+ M.D, or D.O. required. Postgraduate training/certification /fellowship in a medical specialty . Demonstrated scientific productivity (e.g. doctoral thesis, publications, research reports, etc.). Post-graduate training in biomedical sciences or one of the disciplines related to drug development

+ At least 10 years of experience in conduct and execution of clinical trials, including recruitment, investigator performance, investigative site relations

+ Previous leadership / management experience and training

+ Knowledge and experience in Good Clinical Practices

+ Thorough understanding of local / international regulations applicable to clinical trials (pre and post approval)

+ Practical experience in clinical trial strategies, methods and processes

+ Proven track record of design, oversight and interpretation of clinical studies

+ Proven track record of proactive management of regulatory issues related to protocols and programs, including comprehensive experience of interactions with regulatory authorities


+ Proven ability to get results in a matrixed management environment.

+ Demonstrated ability to design, initiate and conduct clinical studies in industry, academic, or research clinic setting

+ Proven scientific writing skills, with strong inter-personal, written/verbal communication skills, including ability to evaluate, interpret and present complex data

+ Ability to review and understand the emerging safety and efficacy profile of the drug candidate; part of this skill is putting the profile in perspective with comparator agents

+ Collaborative problem solving (handles conflict constructively)

+ Creativity and/or ability to put innovative approaches into practice in clinical development

+ Able to discuss investigator performance issues, coach and/or mentor clinical investigative site staff to achieve operational and recruitment goals and quality standards

Able to place innovative approaches into action that focus on trial execution and site performance

**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'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.

**Additional Offer Details:**

+ **Grade:** 20

+ **Additional Location Information** : New York Remote. Consideration given to: LaJolla, CA, Groton, CT, MA-Remote, Collegeville, PA

A career at Pfizer offers opportunity, ownership and impact.

All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the bio-pharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.

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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