Senior Director, Clinical Development

Foster City, California, United States

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Not SpecifiedCompensation

Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Biopharmaceutical, Rare DiseasesIndustries

Requirements

Candidates must possess a doctoral-level degree (PhD, MD, PharmD) with at least 7 years of industry or clinical trial experience. Experience in rare diseases, particularly in neurology, psychiatry, immunologic diseases, or hepatic diseases is highly desirable. A strong understanding of regulatory requirements for product approval and compliance in the US and Europe is necessary, along with demonstrated accountability for complex development plans, leadership in clinical development programs, and experience presenting data to regulatory agencies.

Responsibilities

The Senior Director of Clinical Development will lead all aspects of global clinical study programs from Phase 1 through regulatory approval. Responsibilities include serving as the primary point of contact for medical inquiries, liaising with internal Clinical Operations for study activities, and supporting the creation and review of clinical documents and presentations. The role involves medical monitoring of clinical trial data, providing strategic input on development plans, overseeing compliance and inspection readiness, and collaborating on scientific publications and presentations. This position will co-lead Study Management Teams with Clinical Operations leads.

Skills

Clinical trial development

Protocol development

Study execution oversight

Data analysis

GCP/ICH compliance

Regulatory requirements

Health authority meetings

Regulatory filing

Global product development strategy

Clinical Operations liaison

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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