Medical Director - Nephrologist

Innova Solutions is immediately hiring for a Medical Director Nephrologist - Remote

Position : Type : Full Time, Contract

Duration : 12 Months

Location : Morrisville North Carolina 27560

As a Medical Director Nephrologist - Remote ,your responsibilities : :

As the world leader in serving science, our Mission is to enable our customers to make the world healthier, cleaner and safer.

We are excited about the opportunities this combination brings to enhance our comprehensive end-to-end offering, enabling customers to move rapidly from scientific idea to approved medicine.

Due to continued growth, Client is now looking to appoint an Clinical Trial Physician, Neurology, 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 Client 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 Neurology 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

Comments :

East Coast US, or able to work East coast hours

• Board certified or board eligible in nephrology
• Medical director or senior medical director level with clinical development industry experience a must
• Previous CRO or Pharma experience
• Please target candidates with previous Med Director titles
• Note regarding previous med director experience : There is a distinction in industry in medical science liaison / medical affairs (which is more interactions with physicians), marketing VS clinical development (which is managing a drug through Ph1-4).

These roles may have the same title of medical director but require different skillsets. We are targeting the latter with clinical development work experience.

Phone : Email :

Email :

PAY RANGE AND BENEFITS :

Pay Range* : $131 / hr. -$135 / hr. on w2.

Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc.

Benefits : Innova Solutions offers benefits( based on eligibility) that include the following : Medical & pharmacy coverage, Dental / vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP).