Chief Medical Officer job at HiredChina Abroad, US

Job Description

MD (Medical Doctor) or equivalent medical degree is required; specialization in internal medicine, immunology, oncology, or related fields is preferred.
10+ years of experience in clinical research and drug development, with at least 2 years in biosimilars or biologics preferred.
In-depth understanding of EU clinical trial regulations, EMA biosimilar guidelines, and GCP requirements.
Experience with Phase I–III clinical trials, including protocol design, medical monitoring, and regulatory interactions.
Proven ability to work with cross-functional teams and manage complex clinical programs across multiple countries.
Excellent communication, analytical, and problem-solving skills.
Fluency in English (written and spoken); additional European languages are a plus.
Ability to travel within Europe as required. - Provide medical leadership and strategic input for the planning and execution of biosimilar clinical trials in Europe.
Lead the development of clinical protocols, investigator brochures, informed consent forms, and other core trial documents in collaboration with clinical operations, regulatory, and biostatistics teams.
Oversee medical aspects of study conduct, including patient safety, medical monitoring, adverse event assessment, and protocol compliance.
Serve as the primary medical point of contact for regulatory authorities, ethics committees, investigators, and CRO partners.
Ensure compliance with ICH-GCP, EMA guidelines, and local regulatory requirements throughout the trial process.
Collaborate with regulatory affairs to support submissions (e.g., CTA, MAA) and respond to health authority queries.
Provide medical input for data analysis, interpretation of clinical results, and preparation of clinical study reports and publications.
Contribute to the development of clinical strategies, clinical development plans, and risk management plans for biosimilar products.
Support cross-functional communication between global headquarters, European affiliates, CROs, and external stakeholders.
Represent the company at investigator meetings, scientific conferences, and regulatory interactions as required.

Job Tags

Local area,

Similar Jobs

Amergis

Dispatch/ Switch Board Operator Job at Amergis

...appropriate person/department Monitors 911 calls from campus and dispatches appropriate unit All emergency calls are received, triaged... ...differences Secondary Responsibilities: Assists in the training of new employees Sends out alerts on campus notification...

Sunrun

Solar Appointment Setter: High-Earning Potential & Growth Job at Sunrun

...A leading solar energy company is seeking a Solar Appointment Setter in Commack, NY. This role involves engaging with potential customers at retail locations, scheduling appointments, and promoting renewable energy solutions. Successful candidates can earn between $45...

Regeneron

Field Reimbursement Manager-Immunology-Columbus, OH Job at Regeneron

...The Field Access & Reimbursement environment for specialty biologics has proven to be highly challenging for HCPs and Patients. Payer Formularies and restrictive Utilization Management Criteria including Prior Authorization Processes, Step Edits, Appeals, detailed Clinical...

University of New Mexico - Hospitals

RN - INPATIENT Job at University of New Mexico - Hospitals

...is based on a number of factors, including but not limited to experience, education, and other business and organizational considerations... ...environment and quality patient care. Ensures adherence to Hospital and Departmental Policies and Procedures. Patient care assignment...

LifePoint Health

Patient Care Technician Job at LifePoint Health

...drive quality, scalability, and significant impact across our hospitals and communities. In your role, you'll support those that are in... ...High school graduate or equivalent preferred. No minimum experience required. Documentation of current State Issued Nursing Assistant...