Lead Study Clinician - Oncology - New York, NY | Biospace
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Lead Study Clinician - Oncology

Pfizer Inc.

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Location:
New York, NY
Posted Date:
12/7/2016
Position Type:
Full time
Job Code:
59767.37031
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

About Pfizer

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 biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.



Role Description

The Therapeutic Area (TA) Clinician - Oncology is accountable for the medical & scientific integrity of the study and the well-being of the patients. This role serves as the protocol owner and applies technical and clinical excellence to ensure the design of cost-efficient clinical trials to meet the needs of internal and external customers. S/he is responsible for effective medical/scientific oversight of studies (in partnership with MD Clinicians, 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 safeguards compliance with internal and external standards, proactively mitigates risk and manages emerging clinical issues. The TA Clinician 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. The TA Clinician will also be the primary contact with external investigators & the internal study team for questions relating to clinical/medical aspects of the protocol.



Responsibilities

* Develops study outline and/or key protocol elements and proactively ensures efficient protocols that minimize the likelihood of amendments
* At the asset level, assists the Global Clinical Lead in the Clinical Development strategy and supports technical review of licensing opportunities
* Accountable for establishing Data Monitoring Committees (DMCs) and endpoint adjudication committees, including chartering, contracts, provision of relevant data and documentation of outcomes
* Reviews and approves CRFs and ICDs, and is accountable for the selection and implementation of PROs
* Reviews and approves Risk Management, Safety Review and Data Review Plans
* Reviews and approves country selection, develops site selection criteria, and ensures protocol specific training
* Approves investigator meeting plans
* Ensures the integrity of clinical & scientific aspects during clinical study execution, analysis and reporting.
* Consistent with Safety Review Plan, performs and documents regular review of individual subject safety data and cumulative safety data with the safety risk lead (as delegated by the Study Clinical Lead or the Global Clinical Lead) - For all studies, clinical safety review should be performed in consultation with a designated medically-qualified Medical Monitor
* Identifies quality issues and discuss with Pfizer clinical/operations study team members so corrective actions may be instituted. - Escalate protocol-related issues requiring medical expertise to medically-qualified medical monitor - Escalate operational issues to the appropriate operations study team member (Clinical Project Manager, Study Manager) * Responsible for clinical and scientific validity of study report, especially conclusions regarding efficacy and safety
* Responsible for disclosure of appropriate safety and efficacy data and conclusions and contributes to primary publication of clinical trial results
* Reviews and manages protocol deviation and approves 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 IB, key safety documents, responses to regulatory queries and audit/inspection findings, CTAs, and submission documents by providing relevant clinical support.

Requirements

Qualifications

Education
* Required: BA/BS or equivalent qualification
* Preferred: M.D., Ph.D., D.V.M., M.S., and/or PharmD. or equivalent qualifications. Postgraduate training/certification /fellowship in a medical discipline or in drug development. Demonstrated scientific productivity (e.g. doctoral thesis, publications, research reports, etc.). Experience
* Practical experience in clinical trial strategies, methods and processes
* Track record of design, oversight and interpretation of clinical studies in oncology
* Previous leadership / management experience or training
* Proven track record of proactive management of regulatory issues related to protocols and programs, including experience of interactions with regulatory authorities
* Knowledge and experience in Good Clinical Practices
* Thorough understanding of local / international regulations applicable to clinical trials (pre and post approval) Capabilities/Skills
* Proven ability to get results in a matrixed management environment.
* Demonstrated potential or 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
* Creativity and/or ability to put innovative approaches into practice in clinical development
* Ability to discuss investigator performance issues, coach and/or mentor clinical investigative site staff to achieve operational and recruitment goals and quality standards
* Ability 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.