Medical Director/Senior Director, Clinical Research
Redmond, WA
Located in Redmond WA, SystImmune Inc. is a bio-pharmaceutical company focused on the treatment of cancer through developing novel therapeutic bi-specific, and tri-specific antibodies, as well as antibody-drug conjugates (ADC's). Our objective is to create biologics that work through systematic intervention on the solid tumor micro-environment, to either directly attack the tumor and/or to activate the immune system to attack the tumor.
Job Summary:
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.
Key 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 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, with limited supervision, for the proactive monitoring of clinical trial safety which is conducted in collaboration with the Safety team.
- 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 as they relate to ongoing clinical study/projects.
- 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 and accountable for complying with those requirements.
- Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research.
Required Skills & Qualifications
- 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 is required.
- 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.
- 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.
- 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.
The hiring pay range for this position is $210,000 - $280,000 per year based on skills, education, and experience relevant to the role.
SystImmune is a stable, well-funded biotech company with a bright future. We offer an opportunity for you to learn and grow while making significant contributions to the company’s success. SystImmune offers a comprehensive benefits package including: 100% paid employee premiums for medical/dental/vision, also STD, LTD, a 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, plus 11 paid holidays and MORE.
SystImmune is an Equal Opportunity Employer. Interested applicants should send their CV and cover letter to
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