Director, Clinical Operations
Company: SystImmune Inc.
Location: Redmond
Posted on: January 15, 2023
Job Description:
Located in Redmond WA, SystImmune Inc. is a bio-pharmaceutical
companyfocused on the treatment of cancer through developing novel
therapeuticbi-specific, and tri-specific antibodies, as well as
antibody-drug conjugates(ADC's). Our objective is to create
biologics that work through systematicintervention on the solid
tumor micro-environment, to either directly attackthe tumor and/or
to activate the immune system to attack the tumor. We are agroup of
highly experienced immuno-oncology scientists utilizing
severaltechnology platforms to develop world class advanced
antibody-based drugtherapies.Major responsibilities:
- Leads the operational strategy and drives the planning,
oversight and execution for clinical trials to achieve program
objectives and high-quality deliverables within established
timelines and budgets.
- Develops and maintains budgets for the study that include short
and long-range clinical forecasting based on clinical activity to
support Clinical Development financial goals.
- Assists in the authoring and ensures timely development of core
clinical trial documents (e.g., study protocols, investigator
brochures, informed consent documents, case report forms,
statistical analysis plans, monitoring plans, data management
plans, etc.) and Regulatory documents (e.g., IND, NDA or BLA) to
ensure the completeness and accuracy.
- Leads contracting/outsourcing process and the development of
clinical outsourcing strategies and plans, including
identification, evaluation, selection of external CROs
(capabilities assessment, project budget, contract negotiations,
etc.).
- Forecasts trial resource needs (external costs); accountable
for the program level clinical operations budget, management and
tracking of trial budget in conjunction with CRO.
- Establishes policies and operational practices to ensure
exemplary medical and ethical standards in collaboration with the
Medical Director and other platform Heads.
- Drives all study activities at a program level, including
investigator recruitment and selection, study start-up, enrollment,
data collection, drug projections, and reports. In conjunction with
the CRO, tracks study status, timelines, enrollment, regulatory
documentation, and site startup status for clinical trials.
- Directs oversight of internal Clinical Operations staff and
external CRO in compliance with GCP and SOPs to ensure operational
plans, timelines, and budgets are aligned with corporate objectives
and standards, as well as program goals. Drafts the oversight plans
and reviews audit reports to oversee the day-to-day performance of
CRO.
- Develops the clinical operations strategy including risk
management and contingency planning. Provides answers and solutions
to abnormal problems in clinical trials.
- Identifies and communicates with therapeutic leaders for
feedback on study protocols, development plans, etc.
- Provides operational leadership for IND, NDA and/or BLA filing
activities for assigned program when applicable, including, but not
limited to development and oversight of cross-functional database
lock activities within timeline; evaluation of clinical data with
vendor partners; provide leadership of operations team for
inspection preparedness.
- Attends and manages study-specific meetings (e.g., Study
Management Meetings, investigator meetings, Regulatory meetings,
etc.) as applicable.
- Familiar with the ethical review mechanism at different levels,
assists the registration and reporting department to submit new
drug registration, and effectively promotes the process of research
approval.
- Willingness and ability to travel domestically and
internationally, particularly China, as required (up to
25%).Qualifications:
- Bachelor's degree in Life Sciences or Pharmacy. Advanced degree
is preferred.
- At least 10 years in the pharmaceutical industry and/or CRO,
with at least 5 years in a leadership role overseeing the
successful execution of clinical trials.
- Demonstrates extensive experience in setup, execution and
operational management of domestic and international clinical
trials from phase I-III across oncology areas.
- Experience in review or writing of clinical protocols, study
manuals, case report forms, and informed consent forms is
required.
- Solid well-grounded experience in critically evaluating,
negotiating and selecting outsourced CRO.
- Ability to meet project timelines and project budgets across
clinical trials.
- Demonstrated success in leading, managing, and providing
guidance to clinical operations study teams including CROs,
consultants and vendors.
- Demonstrates extensive successful experience in cross-function
clinical trials processes from study start-up through study closure
(e.g., data management, safety, biostatistics, medical
writing).
- Strong understanding of global regulatory and compliance
requirements including but not limited to US CFR, FDAand
ICH/GCP.
- Ability to assess complex issues and identify creative,
practical solutions.
- Ability to communicate effectively with physicians, fellow
employees, patients, guests, contractors.
- Ability to multi-task and work in a fast-paced
environment.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 tohr@systimmune.com. SystImmune offers a flexible
schedule, competitive salary, and generous benefits package,
including a heath/dental/vision care package, employer retirement
match, and paid time off!
Keywords: SystImmune Inc., Redmond , Director, Clinical Operations, Healthcare , Redmond, Washington
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