Senior Director, Clinical Operations

Clinical Operations              ·                Watertown, Massachusetts, United States              ·              Full-time

At Neumora, we are pushing the boundaries of science and technology to revolutionize the way patients with brain disease are treated. We are seeking extraordinary individuals to join our team as we grow and advance our pipeline.

Neumora was listed as #1 on BioSpace’s NextGen Bio “Class of 2023,” top life sciences startups to watch!

Reporting to the Head of Clinical Operations, this leader will play a critical role in leading the planning, execution, and management of the organization’s lead neuropsychiatric asset through late-stage clinical trials, life-cycle management, and towards commercialization in collaboration with our CRO partners.  

Responsibilities:

Strategic Planning:

• Develop and execute strategic plans for clinical trial operations, ensuring alignment with the company’s overall goals and objectives.
• Collaborate with the cross-functional “core” teams to integrate clinical operations strategies into broader development plans.

Clinical Trial Management:

• Oversee the design, planning, and execution of clinical trials, including Phase I-III studies, ensuring adherence to timelines, budgets, and quality standards.
• Lead the selection and management of Contract Research Organizations (CROs) and vendors involved in clinical trials.
• Monitor clinical trial progress and identify and mitigate risks and issues that may impact timelines or data quality.

Regulatory Compliance:

• Ensure all clinical operations activities are conducted in compliance with applicable regulatory guidelines, including Good Clinical Practice (GCP) and local regulations.
• Collaborate with regulatory affairs to support regulatory submissions and interactions with health authorities.

Resource Management:

• Build and manage a high-performing clinical operations team, including hiring, training, and development of staff to oversee studies.
• Oversee the allocation of resources, including budget management and forecasting for clinical trial activities

CRO Collaboration:

• Manage and collaborate effectively with CRO partners, ensuring their performance aligns with project timelines, quality standards, and budgetary constraints.
• Manage vendor relationships and negotiate contracts to ensure efficient and cost-effective clinical trial execution.

Data Management and Analysis:

• Collaborate with data management and biostatistics teams to ensure data collection, analysis, and reporting are of the highest quality.
• Review and interpret clinical trial data to support decision-making and data-driven insights.

Quality Assurance:

• Implement and maintain quality assurance processes to ensure the integrity of clinical trial data and compliance with regulatory standards.

Continuous Improvement:

• Drive continuous improvement initiatives within clinical operations processes to optimize efficiency and effectiveness.

Qualifications:

• Bachelor’s degree in life sciences or related field required; advanced degree in a relevant scientific discipline preferred.
• Minimum of 10 years of experience in clinical operations within the biotechnology or pharmaceutical industry, with significant experience in CNS therapeutic areas.
• Proven track record of successful leadership in managing and executing Phase II-III clinical trials.
• Strong understanding of regulatory requirements and GCP guidelines.
• Excellent leadership and team-building skills.
• Exceptional communication and interpersonal skills.
• Strategic thinker with the ability to make data-driven decisions.
• Proven ability to work collaboratively in a cross-functional environment, do what is right, create value, and achieve the extraordinary.

Company benefits include:

• Medical, dental, vision, and life insurance
• 401k plan: Neumora matches 50% of an employee’s eligible contribution, up to the first 6% of salary (up to 3% employer contribution)
• New hire stock options
• Annual paid time off: 15 accrued vacation days, 10 sick days, 12 holidays plus a winter shut-down
• Leave of Absence: Paid family leave, paid short- and long-term disability
• Discretionary year-end bonus
• The salary range posted describes the minimum to maximum base salary range for this position in the location listed.  Actual salary may vary based upon geographic location, work experience, education, licensure requirements and/or skill level and will be finalized at the time of offer. Base Salary Range: $270,000- $285,000

Neumora Therapeutics is a clinical-stage biopharmaceutical company founded to confront the global brain disease crisis by taking a fundamentally different approach to the way treatments for brain diseases are developed. Our therapeutic pipeline currently consists of multiple clinical and preclinical neuroscience programs that target novel mechanisms of action for a broad range of underserved neuropsychiatric disorders and neurodegenerative diseases. Our work is supported by an integrated suite of translational, clinical, and computational tools to generate insights that can enable precision medicine approaches. Neumora’s mission is to redefine neuroscience drug development by bringing forward the next generation of novel therapies that offer improved treatment outcomes and quality of life for patients suffering from brain diseases.

Neumora is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

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