Associate Director, Clinical Operations

Reports to: VP, Head of Clinical Operations

Location: This position may be performed remotely with travel to the Boston area as needed.

Position Summary

This role will have shared responsibility for the strategic and tactical operational leadership across clinical programs, achieving quality and timely completion, with on target spending with established budgets. Individual will ensure successful delivery and execution of studies, including creating and managing study timelines, budgets and study management plans.

Primary Responsibilities

• Lead the study team to design, develop, execute and deliver clinical studies in accordance with clinical development plans and strategy and according to established timelines and budget.
• Serve as a Clinical Operations representative at the program level and liaise cross-functionally to support efficient and timely execution of studies within a clinical program.
• Monitor progress of clinical study activities and report on the progress of the clinical trials within an assigned program, including budget and timelines.
• Lead the evaluation, selection, and oversight of CROs and other vendors to ensure successful clinical study implementation and execution on assigned clinical program. This includes guidance on the framework for contract negotiations and vendor selection, and review and approval of vendor contracts and scope of works.
• Provides strategic and tactical guidance in risk management and anticipate/recognize risks and issues on assigned programs and associated studies; manage resolution and/or escalation of study related issues with management.
• Contribute to the writing and review of clinical documents such as protocols, informed consent forms, investigator brochures, monitoring plans, clinical study reports and DSURs on assigned program.
• Liaise with clinical site staff and investigators as appropriate to ensure optimal Sponsor-site relationships.
• May perform the Clinical Trial Manager (CTM) function on one or more trials as needed.
• Direct initiatives to identify and implement best practices and continuous improvement plans in Clinical Operations.

Qualifications and Key Success Factors

• Bachelor’s degree required; in a scientific field helpful, advanced scientific degree a plus
• 8 years Industry experience directly managing clinical trials required. Must have worked within sponsor organization, although can be in combination with academic and CRO experience.
• In-depth knowledge of clinical study operations, ICH-GCP Guidelines and other applicable regulatory requirements.
• Demonstrated experience in study management/monitoring, as well as working, negotiating and managing performance of CROs and other external partners supporting study execution
• Experience mentoring and directing members of clinical operations teams
• Experience working with cross functional team members (e.g., Quality Assurance, Data Management, Biostats, Medical Writing, Safety, Clinical Supply Chain, Finance)
• Intellectual curiosity: ability to think critically in a fast-paced environment, with a keen sense of urgency and demonstrated creative problem solving.
• Highly organized, detail-oriented, and self-motivated and able to work autonomously, with a passion to deliver quality results
• Strong verbal and written communication skills with an ability to build relationships internally and externally

Compensation & Benefits

At Praxis, we’re proud to offer an exceptional benefits package that includes:

• 99% premium cost covered for medical (Blue Cross Blue Shield), dental, and vision plans
• Bonus program structured to pay on a quarterly basis
• 401k plan with 100% match up to 6% of employee’s contribution (Traditional & Roth)
• Wellness benefit of $200/month towards incredibly flexible options including travel, fitness equipment & memberships, student loan repayment, sports fees and much more
• Unlimited PTO, (2) weeklong shutdowns each year, and a generous extended family leave benefit
• Eligibility for equity awards and Employee Stock Purchase Plan (15% discount)

To round out this world-class total rewards package, we provide base salary compensation in the range of $170,000 to $183,000 annualized. Final salary range may be modified commensurate with job level, education, and experience.

Company Overview

Praxis Precision Medicines is a clinical-stage biopharmaceutical company translating genetic insights into the development of therapies for central nervous system disorders characterized by neuronal imbalance. At Praxis we share a common vision of reshaping the human condition into a more freeing and fulfilled existence by developing high impact medicines for patients and families affected by and living with complex brain disorders. Our core Values of Trust, Ownership, Curiosity and Results are foundational to every aspect of our business and are exemplified by each and every one of our team members.

Diversity, Equity & Inclusion

Guided by our core values, at Praxis Precision Medicines, Inc. we continue to DARE FOR MORE™ to advance, promote, and champion diversity, equity, and inclusion by encouraging individuals to bring their authentic selves and perspectives to work each day. We are an equal opportunity employer and committed to providing opportunities to all qualified applicants without regard to race, religious creed, color, gender identity or expression, age, national origin, sexual orientation, disability, genetics, military service and veteran status, or any other characteristic protected by federal, state, or local laws.

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