Medical Director/ Senior Medical Director

Location
Emeryville, CA
Posted
Nov 08, 2018
Required Education
Doctorate/PHD/MD
Position Type
Full time

Medical Director/ Senior Medical Director

The Medical Director / Senior Medical Director will be integrally involved in all aspects of clinical trial design and execution, including authoring of protocols, site initiation, and medical monitoring, as well as data interpretation and reporting. Position reports to Senior Vice President, Clinical Research and is based in Emeryville, CA.

Responsibilities:

  • Oversees study design, and participate in site selection, conduct, and data interpretation for Phase 1-4 clinical trials, with opportunity to contribute significantly to overall program development strategy;
  • Participates as clinical representative to cross-functional project teams;
  • Provides medical monitoring for clinical trials; review, assess, and report adverse events (AE’s) and serious adverse events (SAE’s) from clinical studies as appropriate;
  • Collaborates with colleagues in Pharmacovigilance to provide routine and ad hoc safety monitoring reports to regulatory agencies; Documents accurately and fully clinical information for regulatory submissions;
  • Contributes to analysis of existing datasets and preparation of abstracts or manuscripts;
  • Interacts closely with research (pre-clinical), and regulatory function;
  • Interacts with and coordinates appropriate scientific and medical activities with internal stakeholders (e.g., Commercial, Clinical operations, Biostatistics, Regulatory) as they relate to on-going clinical projects;
  • Provides medical science education/training to study site personnel, study monitors, and project team members related to therapeutic area, disease, or protocol;
  • Keeps abreast of professional information and technology through conferences and/or medical literature and acts as a therapeutic area resource;
  • Represents Company at external meetings including investigator meetings, scientific association meetings, etc;
  • Ensures compliance with corporate policies and procedures, as well as, US healthcare laws and regulations.

Qualifications:

  • M.D. required, preferably with specialty training in Neurology;
  • 3 years’ experience in drug development within the biopharmaceutical industry is highly preferred, extensive experience in clinical trials in academic setting acceptable;
  • Experience leading the design, conduct, analysis, and reporting of clinical studies;
  • Demonstrated leadership in medical and scientific endeavors;
  • Able and willing to travel up to 25% of time, as required;
  • Track record of prior experiences with successful clinical trial. Can easily point to examples with successful and not-so successful outcomes;
  • Understanding of GCP and regulatory requirements related to clinical studies.
  • Excellent communication skills (written and verbal);
  • Actively seeks input from others;
  • Ability to work effectively in a cross-functional/matrix, team-oriented environment;
  • Ability to preserve calm and professionalism while maintaining a sense of urgency in a fast-paced, entrepreneurial, small company atmosphere;
  • Can successfully leverage external partnerships;
  • Maintains a constant sense of curiosity;
  • Successful experience in fast-paced entrepreneurial environment;
  • Fit with Adamas culture and values.

To apply for this position please send your resume to hr@adamaspharma.com with the job title  in the subject line. Principals only, no recruiters please.

 

Adamas is an Equal Opportunity Employer


The above statements are intended to describe the general nature and level of work being performed by people assigned to this job. This description is not intended to be construed as an exhaustive list of all the responsibilities, duties and skills required.