DNAtrix
  • San Diego, CA, USA
  • Full Time

Position Summary: The Medical Director/Sr. Medical Director serves as the clinical lead and medical monitor for DNAtrix's global oncology trials (Phase 1-3). Additionally, this position ensures the design, implementation and reporting requirements of DNAtrix's clinical trial programs are met with the highest standards of excellence for ethics, scientific merit, and regulatory compliance that supports domestic/international drug approvals. This position reports to the CMO and is based in San Diego, CA.

Specific Responsibilities: 

  • Provides clinical leadership of global oncology clinical trials (Phase 1-3) by ensuring that studies are carried out in accordance with the clinical development plan, GCPs, ICH and FDA and other regulatory authority requirements
  • Serves as the primary medical monitor for assigned study(ies) and is the first point of contact with sites (answers questions about eligibility, enrollment, safety and patient management)
  • Ensures the medical integrity of the company's clinical trials by assisting in medical data review, providing appropriate medical interpretation, responds to regulatory inquires, provides assessment and interpretation of clinical and safety data
  • Leads medical aspects of medical monitoring activities by working closely with internal/external key stakeholders (such as, CRO, principal investigators, and Key Opinion Leaders) by identifying, assessing, monitoring and mitigating the study challenges and works toward solutions
  • Oversees the production of clinical documents required for the conduct of clinical studies, such as clinical protocols (and amendments as needed), informed consent documents, investigator's brochures, and safety management plans in compliance with regulations and good clinical practices
  • Organizes and leads interactions with future principal investigators/Key Opinion Leaders to advance clinical programs
  • Presents aspects of clinical programs at Site Initiation Visits, Investigator's Meetings and scientific conferences
  • Maintains state-of-the-art knowledge of the standard of care and clinical science in relevant therapeutic areas
  • Prepares abstracts for scientific meetings and contributes to manuscripts for publication
  • Travel domestically/internationally (~25%) to clinical sites, CRO, conferences, and meetings

Qualifications: 

  • M.D. required, either with Board Certification in Medical Oncology/Hematology Oncology or Internal Medicine
  • 5+ years of clinical experience in biotech or pharmaceutical industries with at least 2 years in oncology drug development
  • Previous work experience as a medical monitor overseeing Phase 3 clinical trial programs
  • Demonstrated track record of success in the design, execution, monitoring and management of clinical trial programs
  • Experience building and managing collaborations, consultants and outsourced work, including Clinical Research Organizations (CROs)
  • Proven ability to interact with different functional groups, investigators, key opinion leaders and the medical/scientific community
  • Knowledgeable of the drug development process and components needed to run effective clinical plans and protocols

Competencies:  

  • Excellent written and verbal skills; strong technical writing
  • Team-oriented and non-hierarchical; ability to inspire others
  • Effective problem-solving skills; results oriented focus
  • Ability to navigate ambiguity and changing priorities; flexible
  • Highly credible and quickly gains respect of others
  • Well organized
  • Operates with a high level of integrity
  • Ability to build strong working relationships and partnerships with internal/external stakeholders
  • Successful experience in a fast-paced entrepreneurial environment
  • Fit with DNAtrix culture

DNAtrix is an equal opportunity employer

DNAtrix
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