DIRECTOR – CLINICAL PHARMACOLOGY

JOB TITLE: Director, Clinical Pharmacology

LOCATION: San Diego, CA; On-Site; Full Time

Redeployment was created to match great people with great Life Science companies! We are seeking an accomplished Director of Clinical Pharmacology to lead clinical pharmacology strategies for a portfolio of small molecule assets. This role will be responsible for guiding dose optimization, assessing pharmacokinetics, and investigating drug interaction potential.

The Director will collaborate closely with cross-functional teams, including Clinical, Research, DMPK, Biometrics, Translational Medicine, Regulatory, and CMC, to drive effective development strategies. This position requires expertise in study design, data analysis, and regulatory documentation, with a proven ability to represent clinical pharmacology in regulatory submissions.

RESPONSIBILITIES:

• Develop and implement comprehensive clinical pharmacology and pharmacometrics strategies, including dose selection and optimization, to support the advancement of small molecule candidates from pre-IND to clinical development phases.
• Integrate clinical pharmacology insights with a broad understanding of related areas such as clinical development, biostatistics, regulatory affairs, nonclinical studies, and research to inform development decisions.
• Design and oversee clinical pharmacology trials, including protocol design, study planning, data interpretation, and results reporting.
• Prepare and review sections of clinical protocols, study reports, and other documents specific to clinical pharmacology.
• Author regulatory documents (e.g., IND, NDA, IB) and respond to health authority inquiries related to PK/PD and clinical pharmacology data.
• Engage with consultants and vendors, ensuring compliance with quality standards, timelines, and study protocols.
• Review and interpret clinical pharmacokinetic and pharmacodynamic data provided by external vendors.
• Ensure timely execution of PK/PD analyses, including population PK and PK/PD modeling, across studies and programs.
• Present clinical pharmacology data and insights to project teams, senior management, investigators, and other stakeholders.

QUALIFICATIONS:

• Education: Ph.D. or equivalent in Pharmacokinetics, Pharmaceutical Sciences, or a related field.
• Experience: Minimum of 7 years of industry or relevant post-doctoral experience in clinical pharmacology.
• Regulatory Knowledge: Prior experience with NDA/BLA/MAA filings is preferred, along with experience in authoring and responding to health authority inquiries.
• Communication Skills: Demonstrated ability to convey complex pharmacology data effectively to cross-functional teams, senior management, and external stakeholders.
• Analytical Skills: Proficiency in interpreting PK, PD, and PK/PD data to inform program decisions and optimize clinical study designs.

CULTURAL COMPETENCIES:

• Collaborative & Cross-Functional: Thrives in a multi-disciplinary environment, actively working with teams across clinical, regulatory, and research areas.
• Data-Driven & Strategic: Applies deep pharmacology insights and data analysis to support strategic decision-making in clinical development.
• Attention to Detail: Maintains rigorous standards in protocol design, data analysis, and reporting accuracy.
• Effective Communicator: Presents complex data clearly and concisely to internal teams, investigators, and regulatory bodies.

BENEFITS:

• $165K - $265K; DOE
• Medical Insurance: Comprehensive medical plan options, including HMO and PPO plans.
• Dental Insurance: PPO dental plan with coverage for preventive, basic, and major services.
• Vision Insurance: Vision plan with benefits for exams, lenses, and frames.
• Prescription Drug Coverage: Tiered prescription drug coverage with mail-order options.
• Flexible Spending Accounts (FSA): Healthcare and Dependent Care FSAs for eligible expenses.
• Life and AD&D Insurance: Basic life and AD&D insurance with additional voluntary options.
• Short and Long-Term Disability Insurance: Income protection through short-term and long-term disability coverage.
• Employee Assistance Program (EAP): Confidential support and counseling services for employees and dependents.