Clinical Trial Physician – Pediatrician

Cambridge, MA - USA

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

Position Overview

The Clinical Trial Physician Pediatrician provides medical leadership across assigned clinical studies ensuring high-quality data patient safety and regulatory compliance. This role partners closely with cross-functional teams to design monitor and interpret pediatric clinical trials-supporting the companys mission to advance treatments in neurology rheumatology and rare diseases.

Key Responsibilities

Provide medical leadership to study teams-developing and reviewing protocols amendments informed consent forms (ICFs) case report forms (CRFs) and clinical study reports (CSRs).
Oversee medical monitoring of ongoing studies ensuring patient safety endpoint validity and proactive issue escalation to the Global Medical Indication Lead.
Interpret clinical trial data for regulatory submissions (CSRs INDs NDAs MAAs annual reports) and scientific publications.
Serve as the medical liaison for investigators IRBs and health authorities; present at study and safety committee meetings; and deliver medical training for site and CRA staff.
Ensure compliance with Good Clinical Practice (GCP) internal SOPs and ethical standards across all study activities.
Collaborate with cross-functional teams to ensure transparent communication of risks results and study decisions.
When multiple physicians are assigned coordinate consistency in responses to sites IRBs and regulatory agencies.

Required Qualifications

MD or equivalent degree required; active medical license preferred.
Minimum 2 years of clinical experience in pediatrics or relevant subspecialties (neurology rheumatology rare disease).
Alternatively 1 2 years of clinical trial experience within pharma biotech or a CRO environment.
Strong knowledge of medical monitoring and clinical trial operations.
Experience with Paediatric Investigation Plans (PIPs) highly preferred.

Desired Skills

Background in neurology hematology dermatology immunology rheumatology internal medicine or pediatrics.
Previous biotech or pharmaceutical industry experience preferred; CRO experience acceptable.
Excellent verbal and written communication skills in English.
Demonstrated leadership collaboration and decision-making in a matrix team environment.
Strong problem-solving negotiation and cultural awareness skills.

Position Overview The Clinical Trial Physician Pediatrician provides medical leadership across assigned clinical studies ensuring high-quality data patient safety and regulatory compliance. This role partners closely with cross-functional teams to design monitor and interpret pediatric clinical tria...

Position Overview

Key Responsibilities

Provide medical leadership to study teams-developing and reviewing protocols amendments informed consent forms (ICFs) case report forms (CRFs) and clinical study reports (CSRs).
Oversee medical monitoring of ongoing studies ensuring patient safety endpoint validity and proactive issue escalation to the Global Medical Indication Lead.
Interpret clinical trial data for regulatory submissions (CSRs INDs NDAs MAAs annual reports) and scientific publications.
Serve as the medical liaison for investigators IRBs and health authorities; present at study and safety committee meetings; and deliver medical training for site and CRA staff.
Ensure compliance with Good Clinical Practice (GCP) internal SOPs and ethical standards across all study activities.
Collaborate with cross-functional teams to ensure transparent communication of risks results and study decisions.
When multiple physicians are assigned coordinate consistency in responses to sites IRBs and regulatory agencies.

Required Qualifications

MD or equivalent degree required; active medical license preferred.
Minimum 2 years of clinical experience in pediatrics or relevant subspecialties (neurology rheumatology rare disease).
Alternatively 1 2 years of clinical trial experience within pharma biotech or a CRO environment.
Strong knowledge of medical monitoring and clinical trial operations.
Experience with Paediatric Investigation Plans (PIPs) highly preferred.

Desired Skills

Background in neurology hematology dermatology immunology rheumatology internal medicine or pediatrics.
Previous biotech or pharmaceutical industry experience preferred; CRO experience acceptable.
Excellent verbal and written communication skills in English.
Demonstrated leadership collaboration and decision-making in a matrix team environment.
Strong problem-solving negotiation and cultural awareness skills.