Planet Pharma
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https://www.propharmagroup.com
https://www.propharmagroup.com
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Medical Director - Nephrologist
Posted: 04/25/2024
2024-04-25
2024-08-22
Employment Type:
Contract
Job Category: Medical Affairs
Job Number: 605835
Is job remote?: Yes
Country: United States
Job Description
Target PR Range: 107-127/hr
*Depending on experience
Due to continued growth, now looking to appoint an Clinical Trial Physician, Nephrologist, to join our team of Medical Directors in US (East Coast - EST). This role can be office-based or home based.
The Clinical Trial Physician will be responsible for providing medical support and medical advice for clinical trials and safety evaluation within the Pharmacovigilance department.
Essential Functions:
• Provide medical leadership to the study teams, including creating clinical trial protocols while implementing the latest scientific information, contribute to site selection, contribute to review and approval of study protocols and amendments, Clinical Study Reports (CSRs), Informed Consent Forms (ICFs), Case Report Forms (CRFs), protocol deviation decisions and other clinical documents as required for the conduct of clinical trials
• Real time Medical Monitoring of clinical studies: ensure medical validity of each individual primary endpoint as well study subject safety, while ensuring medical issues are identified early . Pro-active escalation and correction of issues in consultation with the Global Medical Indication Lead
• Interpret the clinical trial data for regulatory documents (e.g. CSR, INDs, Annual Reports, NDAs, MAAs, etc.), manuscripts, and other publications as required, in consultation with the Indication Lead
• Medical point of contact for all internal and external stakeholders: Interact with the investigators as needed, answer questions of IRBs and Health Authorities, prepare and present material to the study executive and independent safety committee if applicable; medical training of site staff at Investigator meetings; CRA training in new indications
• Ensure study compliance for all medical aspects by understanding and applying all relevant SOPs and GCP
• Closely collaborate with the cross functional study team members in order for medical risks, issues, and results to be clear to all involved parties
Qualifications - External
Education & Qualifications
• MD or equivalent degree and strong medical knowledge, proven clinical experience managing Nephrology patients in hospital practice
• Significant experience within pharmaceutical industry, clinical trials or pharmaceutical medicine is beneficial
• Is fluent in spoken and written English
• Solid understanding of regulatory guidelines for adverse event reporting
• Strong communication & presentation skills and is a strong team player
We hire the best, develop ourselves and each other, and recognize the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore you will benefit from an award-winning learning and development program, ensuring you reach your potential.
Integrity – Innovation – Intensity – Involvement
If you resonate with our 4i values above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, submit your application – we’d love to hear from you!
*CO/NYC candidates might not be considered
*Depending on experience
Due to continued growth, now looking to appoint an Clinical Trial Physician, Nephrologist, to join our team of Medical Directors in US (East Coast - EST). This role can be office-based or home based.
The Clinical Trial Physician will be responsible for providing medical support and medical advice for clinical trials and safety evaluation within the Pharmacovigilance department.
Essential Functions:
• Provide medical leadership to the study teams, including creating clinical trial protocols while implementing the latest scientific information, contribute to site selection, contribute to review and approval of study protocols and amendments, Clinical Study Reports (CSRs), Informed Consent Forms (ICFs), Case Report Forms (CRFs), protocol deviation decisions and other clinical documents as required for the conduct of clinical trials
• Real time Medical Monitoring of clinical studies: ensure medical validity of each individual primary endpoint as well study subject safety, while ensuring medical issues are identified early . Pro-active escalation and correction of issues in consultation with the Global Medical Indication Lead
• Interpret the clinical trial data for regulatory documents (e.g. CSR, INDs, Annual Reports, NDAs, MAAs, etc.), manuscripts, and other publications as required, in consultation with the Indication Lead
• Medical point of contact for all internal and external stakeholders: Interact with the investigators as needed, answer questions of IRBs and Health Authorities, prepare and present material to the study executive and independent safety committee if applicable; medical training of site staff at Investigator meetings; CRA training in new indications
• Ensure study compliance for all medical aspects by understanding and applying all relevant SOPs and GCP
• Closely collaborate with the cross functional study team members in order for medical risks, issues, and results to be clear to all involved parties
Qualifications - External
Education & Qualifications
• MD or equivalent degree and strong medical knowledge, proven clinical experience managing Nephrology patients in hospital practice
• Significant experience within pharmaceutical industry, clinical trials or pharmaceutical medicine is beneficial
• Is fluent in spoken and written English
• Solid understanding of regulatory guidelines for adverse event reporting
• Strong communication & presentation skills and is a strong team player
We hire the best, develop ourselves and each other, and recognize the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore you will benefit from an award-winning learning and development program, ensuring you reach your potential.
Integrity – Innovation – Intensity – Involvement
If you resonate with our 4i values above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, submit your application – we’d love to hear from you!
*CO/NYC candidates might not be considered
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