Director, Clinical Operations Jobs

Company Overview:

Vividion is a next generation biotechnology company based in San Diego that is leveraging its proprietary chemical proteomics platform to conduct proteome-wide footprinting of drug-protein interactions with unprecedented breadth and precision. Our technology allows us to screen, identify and optimize novel drugs that selectively bind to virtually any protein, including proteins previously considered “undruggable.” Our pipeline and emerging programs reflect a matured and productive platform capable of delivering first-in-class drugs utilizing novel mechanisms of action (allosteric inhibitors, protein-protein interaction inhibitors, functional activators, degraders, etc.) against undruggable targets in the oncology and immunology space.

We prize scientific excellence, creativity, team players and we are committed to continued innovation. We have worked hard to create a collaborative and dynamic work culture where your ideas and discoveries are valued and will have an impact. We are growing and there are opportunities for mentorship and career progression.

Vividion was ranked #2 mid-size company on The San Diego Union-Tribune's 2022 Top Workplaces list.

Job Summary:

Reporting to the Chief Medical Officer, the Director, Clinical Operations will provide clinical operations strategy, planning, initiation, and execution of clinical trials, including vendor selection, contracts and budgets, vendor oversight and management, and proactive risk identification to ensure on-time delivery of quality trials that meet the highest level of compliance.

Essential Duties and Responsibilities:

• Assist in safety monitoring and data management activities
• Oversee tactical implementation of the clinical development plan by managing the timeline, resources, and budget of clinical studies
• Manage CROs to execute clinical trials in accordance with contracted scope, costs, and timelines and within budget; actively engage with CROs on defining, monitoring and reporting on all aspects of key trial performance indicators, including country and site initiation activities, patient screening and randomization rates, and data collection activities; review and approve study documents, review and participate in the preparation of clinical documents (protocols, study reference manuals, documents to be submitted to Regulatory agencies or ethics boards, Standard Operating Procedures, guidelines and departmental policies)
• Lead clinical studies and provide strategic planning, direction, and tracking for completing studies within project timelines
• Lead data review activities in collaboration with data management and other cross functional team members to ensure data quality and proactively address issues associated with the data
• Prospectively identify budget, timeline, and quality risks, proactively communicate risks to management team, internal stakeholders and CRO teams, and bring team together to develop and implement risk mitigation strategies and tactics to enable trials to complete on budget, per specified timelines, and with high-quality data and deliverables
• Collaborate with the senior management team to ensure consistency across the clinical trial portfolio
• Contribute to execution strategy of clinical programs and work collaboratively with the clinical operations group and cross functional team to ensure successful implementation of clinical trials
• Develop request-for-proposals documents and solicit and evaluate bids; lead contracting process with selected CROs, collaborating with relevant departments such as Legal and Finance
• Plan and manage project finances in accordance with the Company’s strategic and operating plans and Finance policies

Experience and education requirements:

• Previous oncology clinical trial experience in early phase development is strongly preferred
• Proven track record in overseeing multiple studies and in successful implementation and completion of clinical trial programs
• BA/BS degree or higher, preferably in the life sciences
• Minimum of 10 years prior clinical trial management experience within the pharmaceutical/biotech industry or relevant clinical research organization
• Thorough knowledge of current clinical research concepts, practices, and FDA regulations and ICH Guidelines regarding drug development phases, clinical trials, clinical study design, and data management methods to ensure that the Clinical Operations remains compliant with GCP and other global regulatory guidelines or laws
• Excellent writing skills as they relate to preparation of regulatory documents
• Prior experience with the preparation of NDAs and MAAs and other regulatory documents
• Demonstration of a broad-based and cross-functional understanding of the drug development process

Required Key Attributes:

• Ability to handle highly sensitive, proprietary, and confidential information
• Excellent oral and written communication skills
• Proactive in identifying issues and taking initiative to identify solutions
• Ability to work independently as well as in a team environment

EEO & Employment Eligibility:

Vividion Therapeutics, Inc. is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

Privacy Policy:

The protection of your personal information is a commitment we take seriously. For information regarding our Privacy Policy (CA candidates) please visit https://vividion.com/publication/privacy-noticeforcalifornia-candidates/.

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