Medical Director OncoGenex Technologies Inc.

PURPOSE: The Medical Director will provide medical and operational leadership for our
Clinical Trials programs. This will include writing clinical protocols and clinical
development plans, and provide oversight of investigational drug safety data and safety
monitoring , and related activities (i.e. adverse event reporting to product safety reviews
for preparation of technical and regulatory documents). He/she will also organize and
chair expert advisory meetings, assist in the supervision of Clinical Operations, and assist
in coordinating site activities as well as some aspects of clinical trial implementation.
ESSENTIAL RESPONSIBILITIES:
The Medical Director will be responsible for:
Designing, developing, and initiating clinical study protocols and required
documentation in compliance with clinical development plans, GCP, and good
medical practice.
Participating in the selection of clinical investigators; providing guidance to
investigators on a study.
Providing medical supervision and training for project teams, study investigational
sites, and contract research organizations regarding the administration of study
agents and protocol procedures.
Providing medical and scientific input in review of clinical data, patient medical
safety data, and laboratory values; maintaining an ongoing assessment of the
safety profile, and efficacy data as appropriate.
Providing medical surveillance on Serious Adverse Event (SAE) reporting, followups,
including after hours coverage of medical emergencies if warranted.
Assisting in planning the overall strategy for clinical drug product development
and assisting Regulatory personnel in IND, CTA, and NDA submission activities as
well as submission of IND safety reports.
Participating in the planning, writing, and review of Clinical Study Reports,
regulatory updates, and submissions.
Assisting with due diligence of new scientific developments, competitor products,
and research in the area of oncology therapies.
Analyzing and interpreting study data for abstracts or publication as required.
Supporting corporate partnering efforts and business development activities by
providing medical expertise and participating in partnership committees/task
groups.
Working with the financial group as needed to assist with producing budgets and
timelines for the clinical development team.
Planning and leading clinical focus groups to create clinical trial and protocol
designs.
Ensuring that operational activities are conducted in compliance with all pertinent
regulatory or statutory requirements (Canada & United States) and in accordance
with the scientific standards, ethical and professional values, management
philosophy, and established priorities, policies, and practices of the Company.
Leading the medical writing for the preparation of Investigator Brochures and
summarization of clinical trial data, including the preparation of study reports,integrated summaries, and clinical portions of package inserts, monographs, SPCs
and other product labelling.
Performing ongoing development and training needs-assessments of team
members using professional training courses to ensure continued personal
development of personnel. Ensuring that team members are trained according to
company guidelines
Performing other tasks and projects as assigned.
QUALIFICATIONS:
M.D. with a minimum of 5 years of Clinical Development experience at strategic
and operational levels in the biotech or pharmaceutical industry
Oncology, Hematology or Immunology background preferred or, at a minimum 5
years experience in designing, managing, and monitoring clinical trials in
oncology indications.
Thorough knowledge of FDA regulatory requirements and ICH/GCP guidelines
essential.
Significant expertise in clinical development, in particular in administration and
execution of clinical programs.
SKILLS:
Hands on, energetic, results-oriented.
Track record of working with internal and external team members (scientists, codevelopment
partners, contract manufacturing organizations, CROs, consultants,
vendors) in a cooperative and collaborative manner.
Pragmatic and strategic thinker who meets objectives and leads by example.
Experience with international trials preferred.
Participation in a clinical trial program resulting in a successful NDA.
Demonstrated proficiency in the implementation, monitoring, and management
of clinical trials, timelines, and budgets with an emphasis on Phase II and III
(including regulatory processes) trials.
Direct experience with supervising and managing clinical personnel and CRO
relationships.
Demonstrated leadership skills; ability to establish excellent collaborative internal
and external relationships.
Must have strong negotiation, presentation, and general communication skills.
Dedication to quality and reliability in all work tasks.
Ability to travel as necessary, consistent with project needs.

Location:	Bothell, WA United States