Pfizer, S.A. de C.V
Associate Director, Clinical Development Medical Director (MD Required)
Pfizer, S.A. de C.V, San Diego, California, United States, 92189
Associate Director, Clinical Development Medical Director (MD Required)
United States – Bothell
United States – New York City
United States – Collegeville
United States – Cambridge
United States – Groton
We’re in relentless pursuit of breakthroughs that change patients’ lives. We innovate every day to make the world a healthier place.
To fully realize Pfizer’s purpose – Breakthroughs that change patients’ lives – we have established a clear set of expectations regarding “what” we need to achieve for patients and “how” we will go about achieving those goals.
Pfizer Research & Development serves as the beating heart of Pfizer’s trailblazing product pipeline, the essence of our mission to bring life‑changing medicines to the world.
Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues.
Job Responsibilities
Is accountable for the medical & scientific integrity of the study and the wellbeing of the patients enrolled in one or more clinical trials.
Is responsible for effective execution of studies and works in close partnership with other clinical and medical colleagues, clinical operations, and other functional lines.
Maintains compliance with internal and external standards, proactively mitigates risk and manages emerging clinical/medical issues through timely, diligent clinical data, safety and protocol deviation review.
Will be the primary contact with external investigators & the internal study team for questions relating to clinical/medical aspects of the protocol and partners with/supports the Global Development Lead regarding study and disease area strategy.
Performs medical monitoring on one or more clinical trials: provides study‑related medical information and assistance, e.g., medical questions from investigators, site personnel and non‑study health care providers, safety findings, medical issues, complex serious adverse events, audits or inspection medical responses.
Contributes to final significant quality event medical assessments.
Conducts and documents periodic safety data reviews and ongoing clinical/medical data review.
Reviews required safety text and endorses significant medical changes in the Informed Consent Document.
Provides clinical/medical input to support development of the protocol design document (PDD) and to the development of data collection tools (SAP, TLFs, BDR).
Leads development of protocol amendments, Protocol Administrative Change Letters, and Dear Investigator Letters.
Authors and manages approval of Informed Consent Documents (ICDs).
Accounts for establishing Data Monitoring Committees (DMCs) and endpoint adjudication committees.
Inputs to, reviews, and approves Risk Management and Safety Review Plan.
Reviews and approves country selection, develops site selection criteria, and contributes to authoring and delivery of site training materials.
Reviews, reports and manages protocol deviations.
Reviews patient level and cumulative data per the data review plan across one or more studies.
Reviews safety data, SAE reports, TME’s, DME’s and tracks and reconciles serious adverse events (SAEs) across a study and leads presentation of data during Safety Review Team meetings.
May act as the medical monitor for one or more clinical trials.
Ensures TMF compliance for clinical documents.
Provides clinical support to the study team or clinical program in response to audits or inspections.
May contribute to clinical sections of regulatory filings and support regulatory queries and audit/inspection findings.
Contributes to continuous improvement and innovative approaches to maximize effectiveness of clinical trial execution.
BASIC QUALIFICATIONS
Obtained a primary medical degree (MD, DO, MBBS, MBChB) from a recognized medical school/university and has Clinical Research experience.
Been licensed by a licensing body/health authority to prescribe medicines independently of supervision for at least 2 years post their intern/house officer/foundation period.
Have maintained registration/Medical License to practice and have always been in good standing with their Medical Licensing Authority.
Clinical research experience in phase 3/pivotal space.
Demonstrated scientific writing skills; scientific productivity via publications, posters, abstracts, and/or presentations.
Preferred Qualifications
Clinical Research experience in industry/CRO.
Cardiometabolic disease experience highly preferred (e.g., cardiology, obesity, endocrinology, nephrology).
Extensive knowledge of clinical development, global and regional regulation, ICH/GCP, adverse event management.
Demonstrated clinical/medical, administrative, and project management capabilities, as well as excellent verbal and written communication skills in English.
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. This position requires permanent work authorization in the United States.
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.
Non‑Standard Work Schedule, Travel or Environment Requirements Global travel may be required.
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United States – Bothell
United States – New York City
United States – Collegeville
United States – Cambridge
United States – Groton
We’re in relentless pursuit of breakthroughs that change patients’ lives. We innovate every day to make the world a healthier place.
To fully realize Pfizer’s purpose – Breakthroughs that change patients’ lives – we have established a clear set of expectations regarding “what” we need to achieve for patients and “how” we will go about achieving those goals.
Pfizer Research & Development serves as the beating heart of Pfizer’s trailblazing product pipeline, the essence of our mission to bring life‑changing medicines to the world.
Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues.
Job Responsibilities
Is accountable for the medical & scientific integrity of the study and the wellbeing of the patients enrolled in one or more clinical trials.
Is responsible for effective execution of studies and works in close partnership with other clinical and medical colleagues, clinical operations, and other functional lines.
Maintains compliance with internal and external standards, proactively mitigates risk and manages emerging clinical/medical issues through timely, diligent clinical data, safety and protocol deviation review.
Will be the primary contact with external investigators & the internal study team for questions relating to clinical/medical aspects of the protocol and partners with/supports the Global Development Lead regarding study and disease area strategy.
Performs medical monitoring on one or more clinical trials: provides study‑related medical information and assistance, e.g., medical questions from investigators, site personnel and non‑study health care providers, safety findings, medical issues, complex serious adverse events, audits or inspection medical responses.
Contributes to final significant quality event medical assessments.
Conducts and documents periodic safety data reviews and ongoing clinical/medical data review.
Reviews required safety text and endorses significant medical changes in the Informed Consent Document.
Provides clinical/medical input to support development of the protocol design document (PDD) and to the development of data collection tools (SAP, TLFs, BDR).
Leads development of protocol amendments, Protocol Administrative Change Letters, and Dear Investigator Letters.
Authors and manages approval of Informed Consent Documents (ICDs).
Accounts for establishing Data Monitoring Committees (DMCs) and endpoint adjudication committees.
Inputs to, reviews, and approves Risk Management and Safety Review Plan.
Reviews and approves country selection, develops site selection criteria, and contributes to authoring and delivery of site training materials.
Reviews, reports and manages protocol deviations.
Reviews patient level and cumulative data per the data review plan across one or more studies.
Reviews safety data, SAE reports, TME’s, DME’s and tracks and reconciles serious adverse events (SAEs) across a study and leads presentation of data during Safety Review Team meetings.
May act as the medical monitor for one or more clinical trials.
Ensures TMF compliance for clinical documents.
Provides clinical support to the study team or clinical program in response to audits or inspections.
May contribute to clinical sections of regulatory filings and support regulatory queries and audit/inspection findings.
Contributes to continuous improvement and innovative approaches to maximize effectiveness of clinical trial execution.
BASIC QUALIFICATIONS
Obtained a primary medical degree (MD, DO, MBBS, MBChB) from a recognized medical school/university and has Clinical Research experience.
Been licensed by a licensing body/health authority to prescribe medicines independently of supervision for at least 2 years post their intern/house officer/foundation period.
Have maintained registration/Medical License to practice and have always been in good standing with their Medical Licensing Authority.
Clinical research experience in phase 3/pivotal space.
Demonstrated scientific writing skills; scientific productivity via publications, posters, abstracts, and/or presentations.
Preferred Qualifications
Clinical Research experience in industry/CRO.
Cardiometabolic disease experience highly preferred (e.g., cardiology, obesity, endocrinology, nephrology).
Extensive knowledge of clinical development, global and regional regulation, ICH/GCP, adverse event management.
Demonstrated clinical/medical, administrative, and project management capabilities, as well as excellent verbal and written communication skills in English.
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. This position requires permanent work authorization in the United States.
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.
Non‑Standard Work Schedule, Travel or Environment Requirements Global travel may be required.
#J-18808-Ljbffr