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.
About The Company
Our client is dedicated to transforming cancer treatment through innovative drug development. With a highly skilled management team and a focus on rigorous scientific research, they are advancing novel therapies to make a meaningful impact in cancer care.
Redeployment is defined as "the process of moving people to a different place or using them in a more effective way." We are a recruiting and executive search firm that uses our size and unique background to provide a personalized hiring experience to startups as they raise money, expand their business, and grow their team. With a focus in the biotech space, our expertise is getting to know and understand company culture, ensuring the RIGHT prospects are connected to the RIGHT companies. Reach out today!