Associate Director / Director, Clinical Operations

Shelby American, Inc.; San Diego (CA); On-site; USD 180,000 - 230,000; Full time

Job summary

Join a pioneering biotechnology company focused on revolutionizing drug development. As the Associate Director/Director of Clinical Operations, you will lead the strategic planning and execution of clinical trials, ensuring compliance and quality while managing vendor relationships. This role offers a unique opportunity to work in a collaborative environment that values innovation and scientific excellence. With a commitment to mentorship and career progression, you will have the chance to make a significant impact in the field of oncology and immunology. If you are passionate about advancing healthcare and thrive in a dynamic setting, this is the perfect opportunity for you.

Benefits

Target Bonus

401k with Company Match

Comprehensive Benefits Package

Medical Insurance

Dental Insurance

Vision Insurance

Life Insurance

Disability Insurance

Qualifications

• 10+ years of clinical trial management experience in biotech/pharma.
• Strong oncology clinical trial experience is preferred.

Responsibilities

• Oversee clinical development plans and manage timelines and budgets.
• Collaborate with teams to ensure successful trial implementation.

Skills

Clinical Trial Management

Oncology Expertise

Regulatory Knowledge

Project Management

Data Analysis

Risk Management

Education

BA/BS in Life Sciences

Advanced Degree (Preferred)

Tools

Clinical Trial Management Systems

Data Management Software

Job description

Description

Note: exact level depending on experience

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 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 has been recognized as a Top Workplace by The San Diego Union-Tribune in 2022, 2023, and 2024.

Job Summary:

The Associate Director / 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:

• Oversee tactical implementation of the clinical development plan by managing the timeline, resources, and budget of clinical studies
• 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
• Lead clinical studies and provide strategic planning, direction, and tracking for completing studies within project timelines
• 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
• 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)
• 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
• Plan and manage project finances in accordance with the Company’s strategic and operating plans and Finance policies
• 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
• Assist in safety monitoring and Data Management activities
• Collaborate with the senior management team to ensure consistency across the clinical trial portfolio

Experience and education requirements:

• 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
• 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
• 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
• Prior experience with the preparation of NDAs and MAAs and other regulatory documents
• Excellent writing skills as they relate to preparation of regulatory documents
• Demonstration of a broad-based and cross-functional understanding of the drug development process

Pay & Benefits:

The anticipated base salary for this position ranges from $180,000 to $230,000 depending on relevant skills, competencies, experience, and education. In addition, this position is eligible for target bonus, long-term-incentives, 401k retirement savings plan with company match, and a comprehensive benefits package which includes medical, dental, vision, life, and disability insurance.

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.

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