Remote Senior Medical Director - Metabolic Studies
Location | Raleigh |
Discipline: | Medical & Pharmacovigilance |
Job type: | Permanent |
Salary: | £Salary: $260,000 - $300,000 Per annum + bonus and stock |
Contact name: | Stuart Gilboy |
Contact email: | stuart.gilboy@rbwconsulting.com |
Contact phone: | 16179821238 |
Job ref: | 21480 |
Published: | about 3 years ago |
Expiry date: | 19 May 2021 11:59 |
Location: Raleigh Durham, NC
An innovative biotech in North Carolina has first in class studies progressing in metabolic and cardiovascular studies including a breakthrough designation for an important Type 1 diabetes study. The Remote Senior Medical Director - Metabolic Studies is the companies first physician role and will allow significant progress to senior leadership levels.
Summary: The Remote Senior Medical Director is ideally a board-certified physician who has experience in clinical trials and significant history in the diabetes-related cardiovascular and/or metabolic disease therapeutic areas. An ideal candidate should have significant experience in management of Type 1 diabetes and would thrive on proactively engaging internal and external leaders. S/he is accountable for the development and execution of Clinical Trial Safety and Medical Plans.
Essential Duties and Responsibilities:
Provides medical expertise across the entire scope of clinical development; participates in strategic planning for programs and clinical trials
Utilizes clinical trials safety expertise and oversees strategic clinical trial progression across the company pipeline
Develops study specific safety management, pharmacovigilance, and risk management plans
Leads drug safety teams to evaluate serious adverse events (SAEs)
Responsible for safety of subjects enrolled in company sponsored clinical studies, assuring medical oversight, including safety reviews and ongoing assessment of risk-benefit within individual studies and overall programs; provides medical input for dose escalation decisions
Reviews and oversees safety data for both clinical and preclinical studies
Interacts with external experts, regulatory agencies, and partner/co-development companies
Directs the setup of safety procedures and development of safety exchange agreements for co-development projects
Maintains intimate knowledge of safety, including any emerging safety concerns and risk/benefit profiles for company compounds, with input for other compounds as needed
Flexibly supports compounds/initiatives outside of primary therapeutic area(s) as directed by business and departmental needs
Responsible for keeping senior and executive management informed of clinical progress and any critical clinical issues, especially the emerging safety profile
Tracks emerging study data to ensure appropriateness of the chosen subject population; proactively assesses the performance of techniques used for endpoint measures on an ongoing basis to ensure data quality
Contributes in close collaboration with Program Leads to the design, execution, safety monitoring, interpreting, and reporting of clinical research studies
Contributes to authoring and development of clinical documents (e.g. clinical development plans, protocols and amendments, informed consent forms, clinical study reports, clinical components of regulatory submissions, clinical components of investigator brochures, etc.), including scientific interpretation of data, discussion, and conclusions
Contributes to authoring summary sections of regulatory applications, such as INDs, CTAs, NDAs, etc., and other regulatory submissions, including safety updates
Education, Experience, and Other Requirements:
MD degree required, (or combination of MD with another graduate degree, such as PhD); board certification preferred; active medical license preferred
Experience in phase II-III clinical trials is essential
Clinical specialization (residency completion, board certification or equivalent) in Internal Medicine, Endocrinology or Pediatric Endocrinology is preferred
Experience in Endocrinology (with diabetes related Cardiometabolic experience) clinical trials and familiarity with the use of electronic portals
At least 4 years of experience in metabolic diseases (with diabetes related cardiovascular experience), with at least 2 years in the pharmaceutical industry; experience in clinical trials in Type1 diabetes desired
Experienced writing clinical study reports, poster presentations, and manuscripts for publication in scientific journals
Demonstrated competence in a pharmaceutical industry medical role, such as: Research Physician, Study Director, Medical Monitor, Clinician or Clinical Scientist, Principal Investigator or Sub-Investigator, Clinical Researcher, Medical Advisor, Study Physician or Clinical Development Physician, or similar roles
Prior experience working with the FDA or EMEA on responses to inquiries for study related information is not required but is preferred
For more information on this role please forward an up to date resume to stuart.gilboy@rbwconsulting.com and arrange an informal discussion.
Salary: $260,000 - $300,000 Per annum + bonus and stock
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