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Sr. Manager, Clinician Tofacit
•30 days ago
| Hours | Full-time, Part-time |
|---|---|
| Location | Groton, Connecticut |
About this job
Org Marketing Statement
All over the world, Pfizer colleagues are working together to positively impact health for everyone, everywhere. Each position at Pfizer touches and contributes to the success of our business and our world. That's why, as one of the global leaders in the biopharmaceutical industry, Pfizer is committed to seeking out inspired new talent who share our core values and mission of making the world a healthier place.
Role Description
The Clinician is responsible for high quality and timely delivery of one or more interventional clinical trials for a GIPB medicine. They apply technical excellence in the design of cost-efficient clinical trials to meet the needs of internal and external customers, ensure effective conduct and medical/scientific oversight of studies (in partnership with Development Operations) and support appropriate interpretation and communication of clinical trial data (including high quality regulatory submissions and product defense activities). They ensure compliance with internal and external standards, proactively mitigate risk and manage emerging clinical issues.
Depending on the program, the Clinician may manage a group of 1 to10 Study Clinicians.
Responsibilities
CLINICAL TRIALS:
* Co-chairs clinical study team and works collaboratively with other study team members.
* Point of accountability to the BU for design, conduct, interpretation and reporting of one or more clinical studies (or elements of those studies).
* Provides clinical and scientific expertise to the clinical trial strategy and protocol development process, including acquisition of knowledge of competitor products.
* Through application of ECTD/EQDD, ensures the most efficient clinical protocols are developed.
* Designs/writes clinical trial outlines, protocols and amendments, in collaboration with internal contributors (e.g. statisticians, Outcomes Research (OR) specialists, clinical pharmacologists, clinical project managers, regional medical monitors, market access colleagues, commercial development colleagues), internal experts (e.g. clinical disease area expert, clinical program lead, global clinical lead, global clinical strategy lead), and external experts (e.g. investigators, key opinion leaders, advisory board members); ensures design is consistent with objectives.
* Proactive in authoring protocols that minimize the likelihood of amendments. Identifies and assesses study risks to good clinical practices, subject rights/safety and data integrity throughout protocol development and study conduct; creates, implements and assesses effectiveness of mitigation plans.
* Provides clinical input to Study Team for monitoring guidelines, iqRAMP, statistical analysis plans, informed consent documents, clinical review forms, data edit checks, data quality planning, RMM-Medical Oversight Plan as needed (ultimately oversees work of Study Team).
* Contributes to CRO / vendor selection to ensure study is conducted consistent with protocol requirements, clinical plan expectations, and study timelines; this includes ensuring medical/technical requirements for data integrity are applied (e.g. lab specifications).
* Approves selection of countries, clinical sites and investigators with appropriate qualifications, patient populations, and recruitment strategy to meet goals in a timely, high quality and cost effective manner.
* Ensures study is registered on www.ClinicalTrials.gov, study details are kept up-to-date and basic results are disclosed as required.
* Creates (and where appropriate, delivers) clinical/protocol training materials for study and site management and for use during site initiation visits and investigator meetings.
* Helps establish and oversees Data Monitoring Committees (DMCs) and endpoint? adjudication committees, including chartering, contracts, provision of relevant data and documentation of outcomes.
* Jointly accountable with study team for study enrollment and adherence to agreed timelines for study deliverables.
* Consistent with Safety Review Plan (SRP), performs and documents regular review of individual subject safety data and cumulative safety data with the safety risk lead (as delegated by the Clinical Program Lead or the Global Clinical Lead). For all studies, clinical safety review should be performed in consultation with a designated medically-qualified Medical Monitor.
* Responsible for identifying emerging safety trends and raising them forward for further discussion with the Clinical Program Lead and/or Global Clinical Lead; follows up with investigators for specific safety findings (e.g. SAEs).
* Reviews and manages protocol deviations.
* Works with study team to ensure high quality of data, e.g. appropriate patient population, adequacy of clinical assessments etc., as study is ongoing.
* Conducts clinical review and interpretation of efficacy and safety data from clinical trials; this includes delivery of top-line report in collaboration with study statistician, and delivery of clinical study report in collaboration with medical writer; accountable for overall quality and timeliness of analysis and reporting.
* 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.
* Ensures narrative strategy for clinical trial(s) is consistent with program narrative strategy; writes (or oversees writing of) safety narratives.
* Assists in ensuring regulatory compliance for clinical trials and reporting.
* Contributes to primary publication of clinical trial results.
* May act as primary contact with external investigators and internal study team for questions relating to the clinical/medical aspects of the protocol.
* Responsible for keeping Clinical Program Lead and/or Global Clinical Lead informed of any critical issues relating to benefit:risk evaluation, or study delivery in line with agreed budget, timelines and quality.
* Presents to internal and external advisory committees (e.g. Technical Review Committee, advisory boards) on design of clinical trials and data from clinical trials.
GENERAL:
* Motivates and engages colleagues in an understanding of disease and commitment and excitement to an indication and mechanism.
* Coaches and mentors less experienced clinicians; may directly manage clinicians.
* Maintains and enhances knowledge in relevant disease area and/or technical area (eg pediatrics, regional clinical trials) and practice guidelines relevant to the regions in which clinical trials are being conducted.
* Interfaces with other Pfizer sites, other BUs and other functions to develop and share best practices, as appropriate.
* May organize expert panel, consultant or advisory board meetings to provide input to protocols, clinical plans or data analysis.
* Provides clinical assistance regarding Scientific and Commercialization Support (SCS) for approved medicines, co-promotions, product defense, and clinical consultation on epidemiology and OR studies.
* Assists in the development of publications, abstracts, and/or presentations.
* Leads or assists in the preparations of the clinical content of regulatory submissions/documents (e.g. NDA, MAA, IND, sNDA, IB, AR).
* Assists in discussions with regulators and with the resolution of queries from drug regulatory agencies / ethics committees; leads or contributes to writing and review responses to regulatory queries.
* May support technical review of licensing opportunities, including due diligence activities.
* Ensures compliance with global and local training requirements and adherence to relevant global / local SOPs and CTPQS.
* May also fulfill role of Medical Monitor (see attachment if applicable).
* Contributes to (or leads) continuous improvement activities, and to education and training of clinical staff in areas of competence/experience.
Qualifications
EDUCATION:
* Required: BA/BS or equivalent qualification.
* Preferred: M.D., Ph.D., D.V.M., M.S., and/or Pharm.D 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:
* Preferred: Thorough understanding of local / international regulations applicable to clinical trials (pre and post approval). Practical experience in clinical trial strategies, methods and processes . Track record of design, oversight and interpretation of clinical studies. Previous leadership / management experience or training.
SKILLS:
* 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.
* Able to present complex, technical ideas and concepts, both verbally and in writing, in such a way that they are understood by colleagues and stakeholders at all levels and/or from other disciplines.
* Collaborative problem solving (handles conflict constructively).
* Creativity and/or ability to put innovative approaches into practice in clinical development.
* Able to embody Pfizer leader behaviors and the OWN-IT culture.
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.
All over the world, Pfizer colleagues are working together to positively impact health for everyone, everywhere. Each position at Pfizer touches and contributes to the success of our business and our world. That's why, as one of the global leaders in the biopharmaceutical industry, Pfizer is committed to seeking out inspired new talent who share our core values and mission of making the world a healthier place.
Role Description
The Clinician is responsible for high quality and timely delivery of one or more interventional clinical trials for a GIPB medicine. They apply technical excellence in the design of cost-efficient clinical trials to meet the needs of internal and external customers, ensure effective conduct and medical/scientific oversight of studies (in partnership with Development Operations) and support appropriate interpretation and communication of clinical trial data (including high quality regulatory submissions and product defense activities). They ensure compliance with internal and external standards, proactively mitigate risk and manage emerging clinical issues.
Depending on the program, the Clinician may manage a group of 1 to10 Study Clinicians.
Responsibilities
CLINICAL TRIALS:
* Co-chairs clinical study team and works collaboratively with other study team members.
* Point of accountability to the BU for design, conduct, interpretation and reporting of one or more clinical studies (or elements of those studies).
* Provides clinical and scientific expertise to the clinical trial strategy and protocol development process, including acquisition of knowledge of competitor products.
* Through application of ECTD/EQDD, ensures the most efficient clinical protocols are developed.
* Designs/writes clinical trial outlines, protocols and amendments, in collaboration with internal contributors (e.g. statisticians, Outcomes Research (OR) specialists, clinical pharmacologists, clinical project managers, regional medical monitors, market access colleagues, commercial development colleagues), internal experts (e.g. clinical disease area expert, clinical program lead, global clinical lead, global clinical strategy lead), and external experts (e.g. investigators, key opinion leaders, advisory board members); ensures design is consistent with objectives.
* Proactive in authoring protocols that minimize the likelihood of amendments. Identifies and assesses study risks to good clinical practices, subject rights/safety and data integrity throughout protocol development and study conduct; creates, implements and assesses effectiveness of mitigation plans.
* Provides clinical input to Study Team for monitoring guidelines, iqRAMP, statistical analysis plans, informed consent documents, clinical review forms, data edit checks, data quality planning, RMM-Medical Oversight Plan as needed (ultimately oversees work of Study Team).
* Contributes to CRO / vendor selection to ensure study is conducted consistent with protocol requirements, clinical plan expectations, and study timelines; this includes ensuring medical/technical requirements for data integrity are applied (e.g. lab specifications).
* Approves selection of countries, clinical sites and investigators with appropriate qualifications, patient populations, and recruitment strategy to meet goals in a timely, high quality and cost effective manner.
* Ensures study is registered on www.ClinicalTrials.gov, study details are kept up-to-date and basic results are disclosed as required.
* Creates (and where appropriate, delivers) clinical/protocol training materials for study and site management and for use during site initiation visits and investigator meetings.
* Helps establish and oversees Data Monitoring Committees (DMCs) and endpoint? adjudication committees, including chartering, contracts, provision of relevant data and documentation of outcomes.
* Jointly accountable with study team for study enrollment and adherence to agreed timelines for study deliverables.
* Consistent with Safety Review Plan (SRP), performs and documents regular review of individual subject safety data and cumulative safety data with the safety risk lead (as delegated by the Clinical Program Lead or the Global Clinical Lead). For all studies, clinical safety review should be performed in consultation with a designated medically-qualified Medical Monitor.
* Responsible for identifying emerging safety trends and raising them forward for further discussion with the Clinical Program Lead and/or Global Clinical Lead; follows up with investigators for specific safety findings (e.g. SAEs).
* Reviews and manages protocol deviations.
* Works with study team to ensure high quality of data, e.g. appropriate patient population, adequacy of clinical assessments etc., as study is ongoing.
* Conducts clinical review and interpretation of efficacy and safety data from clinical trials; this includes delivery of top-line report in collaboration with study statistician, and delivery of clinical study report in collaboration with medical writer; accountable for overall quality and timeliness of analysis and reporting.
* 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.
* Ensures narrative strategy for clinical trial(s) is consistent with program narrative strategy; writes (or oversees writing of) safety narratives.
* Assists in ensuring regulatory compliance for clinical trials and reporting.
* Contributes to primary publication of clinical trial results.
* May act as primary contact with external investigators and internal study team for questions relating to the clinical/medical aspects of the protocol.
* Responsible for keeping Clinical Program Lead and/or Global Clinical Lead informed of any critical issues relating to benefit:risk evaluation, or study delivery in line with agreed budget, timelines and quality.
* Presents to internal and external advisory committees (e.g. Technical Review Committee, advisory boards) on design of clinical trials and data from clinical trials.
GENERAL:
* Motivates and engages colleagues in an understanding of disease and commitment and excitement to an indication and mechanism.
* Coaches and mentors less experienced clinicians; may directly manage clinicians.
* Maintains and enhances knowledge in relevant disease area and/or technical area (eg pediatrics, regional clinical trials) and practice guidelines relevant to the regions in which clinical trials are being conducted.
* Interfaces with other Pfizer sites, other BUs and other functions to develop and share best practices, as appropriate.
* May organize expert panel, consultant or advisory board meetings to provide input to protocols, clinical plans or data analysis.
* Provides clinical assistance regarding Scientific and Commercialization Support (SCS) for approved medicines, co-promotions, product defense, and clinical consultation on epidemiology and OR studies.
* Assists in the development of publications, abstracts, and/or presentations.
* Leads or assists in the preparations of the clinical content of regulatory submissions/documents (e.g. NDA, MAA, IND, sNDA, IB, AR).
* Assists in discussions with regulators and with the resolution of queries from drug regulatory agencies / ethics committees; leads or contributes to writing and review responses to regulatory queries.
* May support technical review of licensing opportunities, including due diligence activities.
* Ensures compliance with global and local training requirements and adherence to relevant global / local SOPs and CTPQS.
* May also fulfill role of Medical Monitor (see attachment if applicable).
* Contributes to (or leads) continuous improvement activities, and to education and training of clinical staff in areas of competence/experience.
Qualifications
EDUCATION:
* Required: BA/BS or equivalent qualification.
* Preferred: M.D., Ph.D., D.V.M., M.S., and/or Pharm.D 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:
* Preferred: Thorough understanding of local / international regulations applicable to clinical trials (pre and post approval). Practical experience in clinical trial strategies, methods and processes . Track record of design, oversight and interpretation of clinical studies. Previous leadership / management experience or training.
SKILLS:
* 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.
* Able to present complex, technical ideas and concepts, both verbally and in writing, in such a way that they are understood by colleagues and stakeholders at all levels and/or from other disciplines.
* Collaborative problem solving (handles conflict constructively).
* Creativity and/or ability to put innovative approaches into practice in clinical development.
* Able to embody Pfizer leader behaviors and the OWN-IT culture.
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.
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