Medical Monitor (San Diego Based)

Location
San Diego, CA
Salary
Base plus Bonus plus Options!
Posted
Jun 13, 2018
Required Education
Doctorate/PHD/MD
Position Type
Full time

This an exciting time to join Arena Pharmaceuticals, a clinical stage biotechnology pharmaceutical company with a robust portfolio of assets across multiple therapeutic areas.  We are in search of medical leadership to join our team to support multiple Phase 3 programs as well as an early stage portfolio.

This role will provide medical and scientific expertise in collaboration with cross-functional teams to ensure successful execution of clinical activities, data analysis, and interpretation. We have openings in our San Diego and Zug, Switzerland offices.

What you’ll dive into

  • Serve as the medical resource in support the project team
  • Manage the development of clinical trials and provide medical monitoring during the course of clinical trials
  • Implement safety monitoring plan to ensure study subject safety
  • Participate in analysis, interpretation and presentation of study data to appropriate teams and meetings (governance, KOL, regulatory)
  • Prepare, manage and review clinical study, regulatory and other safety documents as appropriate
  • Support preparation of abstracts, manuscripts, and presentations for external meetings as well as author clinical sections of regulatory documents (IB, IND sections)
  • Ensure study compliance to GCP/ICH and relevant SOPs
  • Collaborate with clinical operations to support timely and on budget development and execution of the clinical program
  • Participate in long range strategic planning for products in development
  • Collaborate with leading academic medical centers and foster relationships with thought leaders and investigators
  • Assist senior management to oversee quality, coordination and timeliness of clinical sections of INDs, investigator brochures, ISS’s, ISE’s, and clinical expert reports
  • Represent clinical research through membership on trial teams
  • Educate Arena colleagues as well as external health care professionals about assigned programs, as appropriate

What we expect

  • MD required, board certification
  • Experience in pulmonary hypertension, inflammatory bowel disease, autoimmune disease, pain, and/or coronary/vascular disease, a plus
  • 10+ years industry experience in clinical development, in global, cross-functional teams
  • Experience in protocol development and design, including understanding of the strengths and weaknesses of study design, development of case report forms and statistical analysis plans
  • In depth experience developing and executing the scientific and clinical principles necessary to conduct complex clinical trials
  • Strong knowledge and respect of ICH / FDA / EMA regulations and guidelines, and applicable international regulatory requirements
  • Experience working closely with investigative sites, and clinical trial personnel
  • Motivated to work in a fast-paced, high accountability, small company environment
  • A “can do” and collegial professional who leads through influence and interpersonal skills
  • Ability to work in partnership with a multidisciplinary group of colleagues and translating concepts into practical approaches
  • Experience managing projects in a matrix environment
  • Able to travel up to 20%

 What you’ll get

  • To be a part a growing company and fantastic team passionate about developing novel drug therapies to improve people’s lives

  • Opportunities to learn and contribute creative solutions

  • Comprehensive health insurance ($0 premium on select medical plans)

  • Matching 401k retirement plan

  • Paid time off and holidays including a Summer & Winter break

  • Company celebrations