- Lead and oversee all aspects of assigned clinical program (s) from Investigational New Drug (IND) through late-stage phases of the clinical program.
- Develop and implement comprehensive clinical operations plans for assigned clinical programs in collaboration with the cross-functional teams, considering global regulatory requirements.
- Collaborate with the VP of Development Operations, to ensure prioritization and alignment of resources and budgets across assigned clinical programs.
- Provide leadership to clinical studies to ensure study teams are managed in alignment with clinical program and company goals.
- Give regular clinical program updates, including trial status, metrics, budget, accomplishments and risks to relevant stakeholders and Senior Management.
- Provides operational and strategic input and/or approves clinical study documents, such as project timelines, protocols, investigator brochures, pharmacy manuals, laboratory manuals, informed consent, study start-up plans, monitoring plans, CRF Completion Guidelines and CSR.
- Responsible for and participates in clinical service provider (vendor) selection process as a part of outsourcing activities.
- Provides oversight for all vendor operational activities (e.g., study management, monitoring, specifications development, UATs, issues escalations).
- Oversees/responsible for the TMF set-up, ongoing quality review and final reconciliation of study documents including review of site regulatory documents/packages.
- Identify, manage, and maintain relations with clinical trial sites, including collaboration with PIs and patient recruitment strategies to deliver enrollment targets.
- Perform or oversee co-monitoring visits to ensure monitoring is being conducted in alignment with ICH/GCP guidelines and study-specific monitoring plan.
- Prepare teams for regulatory agency audits and address any audit observations appropriately in collaboration with Quality.
- Implement best practices and standards for clinical operations including development of internal standard operating procedures as needed.
- Manage the performance and professional development of direct reports, emphasizing the importance of adaptability, execution of clinical studies by embracing changes, and through shifting strategic priorities.
- Bachelors or Master's Degree in health related field is required.
- Minimum of 12 years managing global Phase 1-IV clinical studies. On-site monitoring experience strongly preferred.
- Minimum of 4-6 years of prior supervisory experience.
- Expert knowledge of ICH/GCP guidelines, regulatory requirements, and industry best practices.
- Hands-on experience in contract review and negotiation with CROs and vendors under the legal team's support.
- Previous experience leading multiple trials; leading multidisciplinary trial teams in a complex matrix environment and proven ability working in a fast-paced environment.
- Strong ability to prioritize tasks and keen attention to detail.
- Excellent writing, communication, and presentation skills.
- Strong interpersonal skills with the ability to interact effectively with all levels of associates both within and outside the organization.
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Sr Director, Clinical Operations - San Mateo, United States - Kronos Bio
Description
About Kronos BioKronos Bio, Inc. is dedicated to the discovery and development of first-in-class therapies that modulate historically undruggable targets.
We leverage deep capabilities in high-throughput small molecule microarrays (SMM), targeted protein degradation, and cancer biology in order to identify potent and selective compounds against transcription factors and other central drivers of oncogenic signaling.
Summary of Position:
We are seeking an experienced and dynamic individual to join our team as Senior Director of Clinical Operations.
The successful candidate will provide leadership to assigned clinical program (s) and for ensuring studies (IND through late stage) are being managed in accordance with the company's overall program goals, timelines, budget and quality expectations.
Reporting to Vice President of Clinical Development Operations, this role requires strong leadership skills, strategic thinking and an individual who thrives in fast paced biotech environment and is willing to wear multiple hats to drive success.
Essential Duties and Responsibilities:
Qualifications:
The expected annual salary range for this full-time position is $240,000 - $295,000, plus eligibility for bonus, benefits, and equity incentives.
Actual pay will be determined based on experience, qualifications, business needs, internal equity, and alignment with market data.Disclaimer:
Kronos Bio requires all U.S. employees to receive the COVID-19 vaccines in order to work onsite in our offices.
"Full vaccination" is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered.
Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification.
They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.
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