Head of Clinical Operations (Associate Director/Director/Sr. Director)

The Associate Director/Director/Sr. Director of Clinical Operations will be an essential part of the clinical development team and will report to the Chief Medical Officer. The position will be responsible for the oversight and execution of multiple clinical trials assessing the safety and efficacy of Attobody-based therapeutics, and for establishing and leading meetings with CROs and other functional service providers. Responsibilities include providing leadership to study teams to ensure clinical trials meet corporate timelines and are conducted in accordance with Good Clinical Practices (GCPs) and other applicable regulatory requirements. Additionally, a significant responsibility includes representing Clinical Operations as a member of cross-functional program teams that define, implement, and execute the global development strategies for Attovia's pipeline programs. This is an on-site position. #LI-Onsite

Key Responsibilities

• Establish and coordinate all ongoing study management activities, including leading a cross-functional study team(s) to develop an overall study execution plan to ensure timely completion of all study deliverables.
• Lead the team in the selection of Contract Research Organizations (CROs) and budget negotiation.
• Develop and maintain effective working relationships with CROs, study sites, and investigators, including performance management and issue resolution.
• Coordinate CRO or other vendor meetings, such as project kick-off and investigator meetings, quarterly face-to-face meetings, and others as necessary to assure alignment and achievement of study goals.
• Contribute to drafting/reviewing/updating study documents (protocols, investigator brochures, informed consent forms, recruitment materials, monitoring plans, pharmacy manuals, clinical study reports, site-facing material, etc.) to support trial conduct.
• Project and track study enrollment.  Coordinate timely review of study metrics to identify trends and discrepancies.
• Resource planning for all clinical programs, anticipating and mitigating risks.
• Maintain oversight of study contracts/budgets, including regular forecasting and internal reporting.
• Review vendor invoices against the scope of work and work completed to date.  Identify and communicate variances.
• Coordinate and plan for availability of clinical and non-clinical supplies required for trial execution.
• Ensure that all clinical activities are compliant with GCP and other applicable regulatory requirements.
• Contribute to the development of abstracts, presentations, and manuscripts for studies, as needed.
• Keep up to date with industry best practices/trends and regulatory requirements and apply knowledge to current programs.
• Contribute to development, training, and implementation of Standard Operating Procedures, as needed.
• Ability to travel in support of clinical trial activities, as needed.

Basic Qualifications

• BA/BS required in a scientific/medical field or equivalent work experience.
• At least 8 years of experience managing multi-center clinical trials at different stages of development within the biopharma industry.
• History of successful project team leadership in the biopharmaceutical industry.
• Demonstrated success identifying, negotiating, and overseeing outsourced clinical operations services and vendors.
• Strong knowledge of the clinical development process and GCP.
• Working knowledge of ICH guidelines and global regulatory requirements.
• Strong personal integrity, upholding high ethical standards and patient-first mentality.
• Takes ownership, solution-oriented, highly resourceful, and pro-active (vs. reactive).
• Life-long learner, growth mindset, aspires to excellence in themselves and others.
• Excellent communicator with the ability to engage with investigators, vendors, and individuals at all levels of the organization.
• Capable of working independently in a fast-paced, team-oriented environment, demonstrating multitasking capabilities.
• Ability and willingness to be hands-on when needed.

Preferred Qualifications

• Experience executing first-in-human and early proof-of-concept studies in dermatology, allergy/immunology, or related fields.
• Experience working at start-up company with less than 100 employees.
• Established relationships with investigators, sites, and vendors in dermatology, allergy/immunology, or related fields.
• Experience managing multiple direct reports.
• Experience developing clinical strategy and presenting to senior management.
• Experience with financial budgeting and reporting.
• Experience in Quality Compliance and Assurance.
• Advanced degree (MS/MA) in a related scientific/medical field.

About Attovia 
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