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Associate Director of Clinical Operations
2 months ago
Verismo Therapeutics: Our team is small but driven with the single focus of bringing lifechanging cell therapies to patients with cancer. With a solid pipeline built around a novel KIRCAR platform our technology has found a way to circumvent the barriers in solid cancer where other CAR therapies have limited success. KIRCARs eliminate the artificial chimeric constructs within T cells and instead use a natural NKcell derived signaling system. This system is potent against both hematologic and solid tumors and in preclinical models is superior to current CART in conferring longterm sustained antitumor function to overcome the challenges posed in solid cancer. We have a strong semivirtual team for CMC clinical product manufacture and clinical investigators already established and moving fast to bring KIRCARs to patients in need.
Our company is comprised of individuals who each bring something unique to the table and are valued for their contributions. Our culture is based on the concept of love what you do and the dedication that builds a team where people do their best and support one another. Because we believe our people are our greatest asset career development is an important aspect of our investment in our team and we encourage work/life balance.
Position Summary:Verismo Therapeutics is seeking a responsible organized and highly motivated individual as the Associate Director of Clinical Operations. This position provides the opportunity to join our growing team in bringing cuttingedge cell therapy treatments through clinical trials for patients in need. The Associate Director of Clinical Operations will play a pivotal role in driving the successful execution of clinical trials for our novel platform KIRCAR cell therapy products. This individual will be responsible for coordinating the planning implementation execution and management of clinical trials across our earlystage portfolio at multiple sites across the US ensuring the highest standards of accessibility quality compliance and patient safety.
Essential Duties & Responsibilities:
Accountable for the planning and execution of clinical studies ensuring compliant timely and highquality delivery
Oversee the selection qualification and management of clinical sites.
Accountable for study level planning feasibility and timelines for study implementation
Responsible for vendor selection and oversight
Accountable for study budgets and coordinating with management to monitor department budget and expenses within approved budget constraints
Oversee monitoring activities and manage CRAs
Works with Data Management for ongoing review of clinical trial data to ensure timely consistent and accurate data.
Interacts with external and internal project team members to assist in the development of study protocols and other essential documents including managing development deadlines and obtaining feedback from key stakeholders.
Responsible for writing study plans and amendments.
Ensures appropriate clinical trial supply strategy is implemented and managed.
Develops implements and maintains processes procedures and programs to improve productivity of clinical operations.
Ensures compliance with ICH/GCP guidelines applicable laws and regulations and SOPs for their designated studies
Facilitates the implementation of operational practices that are effective improve clinical accessibility improve the patient experience and ensure quality.
Organizes and conducts crossfunctional team meetings.
Works closely with members of Study Teams to support clinical quality regulatory compliance and research goals of the program(s).
Keeps up to date on overall activities of the team identifying problem areas and taking proactive and corrective actions.
RequirementsPreferred Experience & Abilities:
Early phase clinical trial experience preferred.
Oncology experience preferred.
Cell therapy experience preferred.
Excellent written and oral communication skills
Strong organizational problemsolving and analytical skills
Ability to manage priorities and workflow
Versatility flexibility and a willingness to work within constantly changing priorities with enthusiasm
Ability to work independently and as a member of various teams and committees
Proven ability to handle multiple projects and meet deadlines
Good judgement with the ability to make timely and sound decisions
Strong interpersonal skills.
Proficient on excel word power point and practice management software
Ability to deal effectively with a diversity of individuals at all organizational levels.
Qualification Requirements:
Bachelor s degree (B.A/B.S.) in related field or equivalent preferred.
68 years related experience or equivalent.
Preferred Experience & Abilities: Early phase clinical trial experience preferred. Oncology experience preferred. Cell therapy experience preferred. Excellent written and oral communication skills Strong organizational, problem-solving, and analytical skills Ability to manage priorities and workflow Versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm Ability to work independently and as a member of various teams and committees Proven ability to handle multiple projects and meet deadlines Good judgement with the ability to make timely and sound decisions Strong interpersonal skills. Proficient on excel, word, power point and practice management software Ability to deal effectively with a diversity of individuals at all organizational levels. Qualification Requirements: Bachelor s degree (B.A/B.S.) in related field or equivalent preferred. 6-8 years related experience or equivalent.
