Medical Director/Senior Director/Executive Director, Clinical Research

$210,000 - $280,000/Yr

SystImmune - Redmond, WA

Full-time - Senior

Redmond, WA

Chemical Manufacturing

About the position

Oversees the direction, planning, execution and interpretation of clinical trials or research activities of a clinical development program. Participates in cross-functional teams to generate, deliver, and interpret high-quality clinical data supporting overall product scientific and business strategy.

Responsibilities

• Manages the design and implementation of one or more clinical development programs based on strong medical and scientific principles, knowledge of compliance and regulatory requirements.
• Oversees project-related education of investigators, study site personnel and internal study staff.
• Has overall responsibility for oversight of clinical studies, monitoring overall study integrity and review, interpretation, and communication of accumulating data pertaining to safety and efficacy of the compound.
• Responsible for oversight of study enrollment and overall timelines for key deliverables.
• Responsible for assessment and reporting of serious adverse events per corporate policy and regulations for those protocols on which assigned.
• Responsible for design, analysis, interpretation and reporting of scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses and other study/program documents.
• Responsible for the proactive monitoring of clinical trial safety in collaboration with the Safety team.
• Evaluates all safety data generated in clinical trials and responds to safety questions from investigator sites and IRBs regarding safety issues and queries.
• May oversee the work of other Medical Director(s) and of Clinical Scientists working on the same or related study/programs.
• Provides in-house clinical expertise for compound(s) and indications, coordinating appropriate scientific and medical activities with internal stakeholders.
• Serves as the medical representative/lead in Clinical Study Team (CST), with responsibility for development of a rigorous, cross-functionally-aligned medical oversight.
• Acts as a clinical interface and actively solicits opinion leader interactions related to the compound and disease area.
• Stays abreast of professional information and technology through conferences, medical literature, and other available training.
• Responsible for understanding the regulatory requirements related to clinical studies and global drug development.
• Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research.

Requirements

• M.D. or equivalent in ex-US countries.
• A minimum of 2 years for Director level and 4 years for Sr Director level of experience in medical monitoring of Oncology clinical trials.
• Experience with Biologicals (ADCs and Immune Oncology preferred).
• Track record of successful management of product safety in phase 1 and/or 2 Oncology clinical trials.
• Experience in the clinical and drug development process in a global pharmaceutical/biotechnology company.
• Preparation of risk management plans, aggregate reports and company core safety information.
• Advanced analytical skills.
• Basic leadership and decision-making skills.
• Advanced communication skills.
• Sound medical judgment and experience in medical safety interpretation of safety findings for clinical trials.
• Basic clinical and/or drug development expertise.
• Good organizational and prioritization skills.
• Intermediate skill in strategic thinking and planning activities.
• Basic negotiation skills and capabilities to influence.
• Good interpersonal skills (i.e. team player).
• Intermediate computer skills (MS Office); knowledge of most common EDC systems, ARGUS, JReview is a plus.
• Working knowledge of MedDRA.
• Basic statistics and Pharmacoepidemiology.
• Ability to work with limited supervision.
• Ability to establish sound working relationships with people globally, in various functions with a wide variety disciplines and backgrounds.
• Flexibility and ability to adapt and learn quickly.
• Ability to work under pressure and to tight deadlines.
• Must possess excellent oral and written English communication skills.
• Willing to travel 20-30% of time.

Benefits

• 100% paid employee premiums for medical/dental/vision.
• STD, LTD.
• 401(k) plan with a 50% company match of up to 3% and a vesting schedule of only 5 years.
• 15 PTO days per year.
• Sick leave.
• 11 paid holidays.