Ensures medical & scientific integrity and the wellbeing of participants enrolled in clinical trials.
Designs and executes high-quality studies, maintains compliance, manages risks and emerging clinical and medical issues, and supports interpretation and communication of clinical data.
Acts as the primary contact for internal and external stakeholders for clinical and medical aspects the protocol.
Supports strategic development and may provide matrix management.
Autonomously and independently leads clinical execution of one or more studies of medium - high complexity and significant business impact.
May be accountable for program level clinical deliverables.
Contributes to continuous improvement / process enhancement activities and innovative approaches to maximize effectiveness of clinical trial execution.
Provides clinical/medical input to support development of the protocol design document (PDD).
Leads development of the protocol and ensures efficient protocols maximizing operational efficiency and minimizing the likelihood of amendments or quality issues.
Performs medical monitoring on one or more clinical trials and provides study-related medical information and assistance.
Responsible for providing clinical/medical input to statistical analysis plan (SAP), tables, listings, figures (TLFs), and blinded data review (BDR).
Tracks and reconciles SAEs across a study and presents data during Safety Review Team meetings.

Requirements

Obtained a primary medical degree (e.g., MD, DO, MBBS, MBChB) from a recognized medical school/university and has 4+ years of experience in biopharmaceutical industry in clinical research and development.
Been licensed by a licensing body/health authority to prescribe medicines independent of supervision for at least 2 years post their intern/house officer/foundation period.
Have maintained registration/Medical License to practice and always have 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.
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, in relating to individuals both inside and outside Pfizer.
Demonstrated experience establishing, managing, and training teams in clinical development.

Benefits

Health benefits to include medical, prescription drug, dental and vision coverage.
Paid vacation, holiday and personal days.
Paid caregiver/parental and medical leave.
401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution.
Relocation support available.

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

clinical researchmedical monitoringprotocol designstatistical analysis planadverse event managementscientific writingdata presentationclinical trial executionrisk managementprocess enhancement

Soft Skills

communication skillsproject managementteam managementstakeholder engagementindependent leadershipstrategic developmentproblem-solvinginterpersonal skillsadministrative capabilitiesscientific productivity

Certifications

medical degreemedical license