Head Of Clinical Operations

Technology has transformed the way we work, communicate, travel, eat, move, and more. Yet in biopharma, it still takes 12 years to develop a single drug. Even today, thousands of diseases affecting hundreds of millions of people have no effective treatment. Accelerating the pace of bringing effective, new medicines to patients is one of the greatest opportunities for humanity. 

Our mission is to develop better drugs, faster using technology. We have built an end-to-end technology-driven drug discovery platform centered around one of the field's largest human genomics databases in neuroscience. We use machine learning to map the complex causes of disease and turn those insights into promising drug candidates on our internal biology and chemistry platforms. We are developing drugs to treat some of the biggest medical challenges today: ALS, Parkinson's Disease, and Alzheimer's Disease.

We closed our Series C with a syndicate of top tier investors (e.g. BlackRock, Eli Lilly, Merck, Section 32, Threshold Ventures, Y Combinator, etc.). We are a team of engineers, neuroscientists, and drug developers united around an audacious vision: to build the next Genentech of the digital age. 

The Head of Clinical Operations is responsible for the overall strategy and management of the Clinical Operations function and has primary accountability for the operational aspects of all clinical investigations, driving for execution of all studies with high quality, on budget, and on time.  The Head of Clinical Operations demonstrates emphasis on proactive planning, risk identification and mitigation, early issue identification, management and resolution, and transparent and timely communication. 

You will...

• The Head of Clinical Operations will be primarily accountable for the leadership, oversight, and strategic and operational activities of the Clinical Operations Function at Verge Genomics reporting to the Chief Medical Officer.
• Will oversee all aspects of study level execution, including but not limited to, managing internal staff and external contractors, such as, Clinical Operations Manager(s), Clinical Trial Coordinator(s), and Clinical Trial Assistant(s) and all vendors supporting clinical trials either directly or indirectly via contract research organizations (CROs) in the US and ex-US.
• Will represent the Clinical Operations Function on Drug Development Program Teams,, contributing strategic and operational expertise, which includes planning, coordination, implementation, execution and management of Clinical programs.
• Will oversee the selection, qualification and management of Clinical research vendors, including CROs, safety laboratory vendors, and other service providers, to ensure proper selection, due diligence, and high-quality deliverables and adherence to budget and timelines during execution. 
• Will monitor clinical study timelines and progress, identify potential issues and key risks, and develop and implement appropriate mitigations to ensure study timelines and budgets are met. 
• Will clearly communicate study status, critical path activities and milestones, and dependencies cross functionally; will proactively drive and foster strong collaborative relationships with internal and external stakeholders, including Program Management, Translational Medicine, Regulatory, CMC, Quality, Safety and Pharmacovigilance, Medical Writing, and Finance.
• Will provide operational expertise in support of the overall strategy and objectives of the clinical development plan(s) and designs of Clinical study protocol(s) and amendments. 
• Will work with Quality to develop and update internal Standard Operating Procedures required to ensure compliance with ICH/GCP guidelines, local, federal and global regulations, and Verge policies and procedures throughout all clinical study activities.
• Will own inspection readiness activities that support audits and regulatory inspections related to the conduct of Clinical studies, and manage any inspections by ethics committees or regulatory bodies together with the Regulatory and Quality functions. 
• Will oversee the development and review of essential clinical study documents and their updates (protocol, ICF, IB, monitoring plans, study manuals, eCRFs, IVRS, etc.).
• Will be accountable for financial planning and management, including budget development, forecasting activities, reviewing and approving invoices, and tracking financial status against approved budget and maintaining budget within forecasting.

You have...

• Bachelor's degree.
• 10+ years experience working in Clinical Operations with a proven track record in successfully leading and managing clinical trials in the biotech and/or pharmaceutical industry.
• Comprehensive knowledge of drug development in biotech and/or pharma. 
• In-depth knowledge of US and exUS regulatory requirements and guidelines governing clinical research, including ICH. 
• Experience in vendor management and oversight of CROs and other clinical service providers.
• Strong leadership and management skills, with the ability to effectively lead and motivate a team of employees, contractors and service providers in a fast-paced environment.
• Excellent communication, collaboration and problem-solving skills.
• Ability to work independently and prioritize tasks effectively, while ensuring attention to detail and meeting deadlines.
• Proficient in G Suite and MS Office software and expert knowledge of Clinical trial management systems, TMFs, eCRF platforms.

$150,000 - $200,000 a year

Our target starting salary for successful US-based applicants for this role is $150,000 to $200,000. To determine starting pay, we consider multiple job-related factors including a candidate's skills, education and experience, the level at which they are actually hired, market demand, business needs, and internal parity. We may also adjust this range in the future based on market data.

This role is eligible for participation in our Annual Performance Bonus Plan (based on company targets by role level and annual company performance) and all employees are offered Equity, subject to the terms of those plans and associated policies.

In addition, Verge Genomics also provides our employees:

*Excellent medical, dental, and vision coverage

*401(k) plan with employer matching for contributions

*Disability insurance, Life insurance, Dependent Care FSA and Healthcare FSA

*Unlimited paid time off

*Paid parental leave

*Access to free onsite fitness center

*Free snacks and lunch for employees who work onsite

*WFH stipend for employees who work remotely

The startup nature of Verge Genomics provides multiple growth opportunities into other areas of the company. As one of the early employees at Verge, your work will have a direct impact on the foundation of a groundbreaking new drug development model.