Senior Clinical Project Manager at Acadia Pharmaceuticals

Foster City, California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Biopharmaceutical, Rare DiseasesIndustries

Requirements

Bachelor’s degree or equivalent in the life sciences or related field required. Additional coursework or certifications in clinical trial planning and operations desired
At least 5 years experience as a global clinical project manager
Experience in rare disease preferred
Experience working in a fully outsourced model
Experience in small, fast-paced biotech is a plus
Experience coordinating in

Responsibilities

Drive the planning, development, and execution of timelines while identifying and tracking the team’s critical path
Facilitate the project team kick-off meeting by identifying key stakeholders and resources
Execute and control project activities, including scope, schedule, budget, and risk associated with each assigned project and report performance to senior management
Establish communication plans for information distribution to team members
Manage project/program meetings
Conduct project/program reviews at significant milestones or gates to evaluate successes as compared to baseline estimates
Integrate understanding of constraints across and within projects and recommend alternatives
Identify and track key study metrics in order to identify/anticipate issues (early) and conduct root-cause investigations for issue resolution and/or escalation (as needed)
Assist the scientific staff in developing and reviewing protocols, investigator brochures, informed consent forms, clinical study reports and other scientific documents
Assist with regulatory submission preparations
Author/Oversee the development of plans and execution of those plans related to project management, site monitoring, safety management, data management and biostatistics
Identify, evaluate, and select external vendors (central lab, CROs, consultants/contractors)
Train and manage CROs and other clinical vendor activities to ensure the quality meets Mirum and regulatory requirements
Perform periodic visits to sites and/or CROs to assess the progress of studies/protocol compliance. Develops/reviews and approves study plans
Develop contracts for and perform ongoing management of vendors to ensure deliverables and performance adhere to contract
Oversee the identification, selection, and proper initiation of sites
Develop patient recruitment strategies to ensure enrollment goals are achieved
Oversee development of CRFs, and clinical databases, support development of safety databases, and shell Tables, Figures and Listings
Plan, coordinate, and conduct investigator meetings
Contribute to planning, coordination and conduct of Data Monitoring Committee (DMC) meetings
With Medical and Safety, assess trends in data including adverse events, protocol violations, etc
Oversee timely database freeze and database lock. Participate in data review meetings
Oversee maintenance of the Trial Master File for each project and oversee the archival process
Ensure adherence to SOPs, GCP and ICH regulations

Skills

Key technologies and capabilities for this role

Clinical TrialsProject ManagementCRO ManagementRisk MitigationTimeline ManagementBudget ManagementCross-Functional TeamsProtocol DevelopmentStudy MetricsRoot-Cause Analysis

Questions & Answers

Common questions about this position

What are the key responsibilities of the Senior Clinical Project Manager?

The role involves overall management and coordination of clinical trials, including planning, execution, budget adherence, risk mitigation, managing CROs, and leading cross-functional teams to ensure projects are completed on time and with high quality.

What is the salary or compensation for this position?

This information is not specified in the job description.

Is this a remote position or does it require office work?

This information is not specified in the job description.

What are the company values at Mirum Pharmaceuticals?

The company values are care, be real, get it done, and have fun, seriously, embodied by collaborative, creative, and experienced professionals.

What experience makes a strong candidate for this role?

Strong candidates should have experience driving clinical trial timelines, managing CROs and vendors, leading cross-functional teams, overseeing site selection and patient recruitment, and handling regulatory submissions and scientific documents.

Acadia Pharmaceuticals

Develops therapies for neurological disorders

About Acadia Pharmaceuticals

Acadia Pharmaceuticals develops therapies for neurological disorders, focusing on conditions like Parkinson's disease, schizophrenia, and Rett syndrome. The company conducts extensive research and clinical trials to create drugs that are safe and effective, seeking approval from regulatory bodies like the FDA before bringing them to market. Acadia differentiates itself by targeting areas with significant unmet medical needs, ensuring that their products address critical health challenges. Their goal is to improve the quality of life for patients suffering from these disorders while also promoting diversity, equity, and inclusion within their operations.

Dallas, TexasHeadquarters

1993Year Founded

$813.4MTotal Funding

ACQUISITIONCompany Stage

Biotechnology, HealthcareIndustries

501-1,000Employees

Benefits

Health Insurance

Dental Insurance

Vision Insurance

401(k) Retirement Plan

401(k) Company Match

Employee Stock Purchase Plan

Paid Vacation

Paid Holidays

Paid Sick Leave

Paid Parental Leave

Tuition Reimbursement

Risks

Increased competition in CNS drug market may impact Acadia's market share.

Potential clinical trial delays could affect drug approval timelines.

Dependence on partnerships poses risks if collaborations face challenges or dissolve.

Differentiation

Acadia focuses on CNS disorders with unmet medical needs, like Parkinson's and Rett syndrome.

The company has a strong R&D foundation, developing innovative small molecule drugs.

Acadia's strategic partnerships enhance its research capabilities and market reach.

Upsides

Acadia's collaboration with Saniona expands its portfolio with SAN711 for neurological disorders.

Health Canada's approval of Daybue boosts Acadia's presence in the Canadian market.

The rise of personalized medicine aligns with Acadia's targeted therapy approach.

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