Pfizer Clinician, Inflammation & Immunology (MD required) in Collegeville, Pennsylvania
This is a global role for a medically qualified clinician, working in Inflammation & Immunology (I&I) within Clinical Development and Operations (CD&O). The role is to provide scientific oversight and accountability to the strategy, methods, processes and execution of clinical trials within the development programs of the I&I portfolio. It may include work on the existing or new phase 3 clinical programs, as required. Some national and international travel will be required.
Qualifications and Experience
Required: M.D. or equivalent medical qualification/licence.
Preferred: Postgraduate training/certification /fellowship in a medical discipline or in drug development. Demonstrated scientific productivity (e.g. doctoral thesis, publications, research reports, etc.).
• At least 5-8 years applicable experience in Phase 2-4 clinical development in the pharmaceutical industry, practical experience in clinical trial execution, strategies, methods and processes. Some therapeutic area experience in immunology, including either rheumatology or dermatology would be desirable, but not essential.
• Previous experience providing medical advice in a clinical research setting, including in academia, as an investigator, at a pharmaceutical company or Contract Research Organization (CRO)
• At least 1 year of post internship experience in medical care of patients
• Proven track record of being a successful medical monitor at the study level or program level
• Has demonstrated knowledge of designing and delivering clinical program(s), to produce both timely and good quality data, including knowledge (and appropriate use) of innovative clinical trial principles and methodologies (e.g. Enhanced Clinical Trial Design (ECTD)/ Enhanced Quantitative Drug Development (EQDD), etc.)
• Regulatory awareness - proven track record of proactive management of regulatory issues related to protocols and programs, including comprehensive experience of interactions with regulatory authorities
The medically qualified Therapeutic Area (TA) Clinician is accountable for the medical & scientific integrity of studies and the well-being of the patients enrolled for I&I clinical trials. This role serves as the protocol owner and applies technical and clinical/medical excellence to ensure the design of cost-efficient clinical trials to meet the needs of internal and external customers.
The clinician will be responsible for effective medical/scientific oversight of studies (in partnership with other TA 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 medically qualified TA Clinician safeguards compliance with internal and external standards, proactively mitigates risk and manages emerging clinical issues.
The medically qualified TA Clinician also supports the Global Clinical Lead (GCL) 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.
In addition to study specific activities, the medically qualified TA Clinician may provide product/program specific medical input for target product profile(s), due diligence activities on potential in-licensing opportunities and regulatory documents as appropriate (e.g. product labels, core data sheets, Investigator's Brochures, Development Safety Update Reports, Periodic Benefit-Risk Evaluation Reports).
TA clinician responsibilities.
Study Design and Set-Up:
• Provides medical input to develop study outline and/or key protocol elements and proactively ensures efficient protocols that minimize the likelihood of amendments in a Therapeutic Area.
• Serves as the primary contact with external investigators and internal study team for questions relating to clinical / medical aspects of protocol
• At the asset level, provides medical input to assist 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
• Provides medical input, reviews and approves Case Report Forms (CRFs) and Informed Consent Documents (ICDs), and is accountable for the selection and implementation of Patient Reported Outcomes (PROs)
• Provides input for the design of the Statistical Analysis Plan (SAP) and the Clinical Data output
• Reviews and approves Integrated Quality Management Plan (IQMP) and 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 medical & scientific aspects during clinical study execution, analysis and reporting.
• Consistent with Safety Review Plan, is accountable for the performance and documentation of regular medical review of individual subject safety data and cumulative safety data, in collaboration with the safety risk lead
• Identifies quality issues and discusses with Pfizer clinical/operations study team members so that corrective actions may be instituted
Reviews protocol-related issues requiring medical expertise
Escalates operational issues to the appropriate operations study team member (Clinical Project Manager, Study Manager)
• 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
• Responsible for clinical and scientific validity of study report, especially conclusions regarding medical components of efficacy and safety
• Responsible for disclosure of appropriate safety and efficacy data and conclusions and contributes to primary publication of clinical trial results.
Other Study-related activities:
• Provides medical advice and oversight to the study team or clinical program in response to audits or inspections, including providing medical advice and support as needed to audit/inspection responses (e.g. site visits if specific medical expertise is required to further investigate or remediate findings)
• Attending and representing Clinical Development &; Operations at governance meetings (including co-development studies)
• Supports and contributes to various sections of regulatory filings (Pediatric Investigational Plan, Investigator Brochure, IND/NDA Annual Reports, and Periodic Safety Update Reports and Regulatory authority responses)
• Assist responsible colleagues with the development of the IB, key safety documents, responses to regulatory queries and audit/inspection findings, Clinical Trial Applications (CTAs), and submission documents by providing relevant clinical support.
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.
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:
Additional Location Information : Preferred Location is Collegeville, PA. Consideration given to: New York, NY; Groton, CT; Sandwich, UK and Walton Oaks, UK.
Eligible for Employee Referral Bonus
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.