​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: 29 days ago
Expiry date: 19 May 2021

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