Senior Director, Clinical Data Management at Acadia Pharmaceuticals

Foster City, California, United States

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Not SpecifiedCompensation

Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Biopharmaceutical, Pharmaceutical, BiotechnologyIndustries

Requirements

Bachelor’s degree in clinical, biological, mathematical sciences or related field is required; an advanced degree is a plus; equivalent experience may be accepted in lieu of the degree requirement
Minimum 12 years of clinical data management experience in biotechnology or pharmaceutical industry
Minimum 10 years of Electronic Data Capture (EDC) experience; IXRS development
Strong knowledge of ICH and GCP and Data Management processes and systems
Solid understanding of clinical drug development processes and agency filing experience
Demonstrated problem solving abilities in a team environment, strong organizational skills, and the ability to work in a fast-paced environment

Responsibilities

Provide clinical data management leadership, expertise, and guidance for strategic optimized planning of clinical development in accordance with corporate objectives
Provide leadership and technical data management input. Represent and communicate data management activities, progress, and risks to cross-functional leads and senior management team
Lead efforts to establish a data-driven culture supporting improving business efficiencies, bolstering use of data, reporting and analytics
Identify, plan, and drive strategic initiatives, policies, implementation and adherence to data management standards and processes
Develop SOPs, training, work processes and standards for data management activities and refine existing processes related to data management
Responsible for the strategic planning and oversight of the Data Management function comprised of internal and external data management professionals and data management supporting groups within biometrics and cross-functionally from safety, clinical development, and clinical operations
Participates in developing innovative ideas and testing new processes and systems for the management of clinical data

Skills

Clinical Data Management

SOP Development

Data Standards

Cross-Functional Leadership

Biometrics

Clinical Development

Data Analytics

Process Optimization

Risk Management

Training Development

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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