Job Details

Position Summary:
The Associate Director, Clinical Pharmacology will be responsible for the design, leadership, and implementation of clinical pharmacology strategies across clinical programs. In this role, you will communicate key Clinical Pharmacology strategies to senior management, regulatory agencies, and external peers. Utilizes scientific expertise to provide appropriate interpretation of data and relates implications of results to management. Serves as liaison to other departments/divisions for any study/project needs. Understands linkages across businesses and understands the impact of business decisions and solutions.
 
Responsibilities:

• Lead the development and execution of clinical pharmacology strategy for assigned development programs, integrating pharmacokinetics (PK), pharmacodynamics (PD), and drug-drug interaction assessments into all stages of clinical trials.
• Represent independently Clinical Pharmacology and provide clinical pharmacology support and guidance to clinical stage project teams.
• Develop and oversee the design and implementation of clinical pharmacology studies (e.g., dose escalation, PK/PD modeling) for early drug candidates, ensuring optimal dosing strategies and evidence generation.
• Provide clinical pharmacology input for regulatory submissions such as briefing documents, IND, CTA and NDA. 
• Reviews clinical protocols and scientific reports for regulatory filings and anticipates regulatory questions.
• Prepare and input independently appropriate documents or sections of clinical protocols, Investigator Brochures, Clinical Study Reports with respect to Clinical Pharmacology studies or data.
• Closely partner with Research, Bioanalytical, Clinical, Regulatory, Project Management, and other R&D functions.
• This position will play a key role in delivering strategic and well-timed clinical pharmacology input at key decision points along the development path.

  
Education/Experience Requirements: 

• Ph.D. degree or equivalent required. Equivalent combination of education and applicable job experience may be considered.
• 4+ years of experience required or Pharm D with 8+ years of experience in a relevant field.
• Knowledge and experience in multiple therapeutic and/or functional areas.
• Experience across range of development phases.
• Must have demonstrated leadership competencies in PK/PD, Biopharmaceutics, and Pharmacometric activities from planning, implementation through completion across multiple projects.
• Scientific project leadership or related experience.
• Project management skills such as scope management, progress tracking/driving as well as time management.
• Participates in initiatives and advancement of Clinical pharmacology.
• Clinical pharmacology and therapeutic knowledge in one or more disease areas.
• Experience with incorporation of MIDD strategies into drug development across all phases and responding to questions on dose and regimen justification and study design.

 
Additional Skills/Experience/Requirements: 

• The ideal candidate will embody company core values: Courage, Community Spirit, Patient Focus and Teamwork.
• Driven, intelligent, passionate about making a difference for patients with rare diseases.
• Ability to work effectively in a multidisciplinary team to cultivate an inclusive environment of respectful, open, and honest dialogue and to foster a robust sharing of ideas and creative problem solving.
• Well organized with the ability to multitask, prioritize and manage shifting responsibilities in a small, fast-moving and entrepreneurial environment.
• Demonstrated ability to review, interpret and present complex scientific data.
• Excellent communication, collaboration, and project leadership skills.
• Ability to manage multiple, complex tasks with competing timelines.
• Self-motivated and can independently manage responsibilities.
• Ability to travel 10% domestically and internationally.
• All positions have an essential job function to be able to perform face to face work with colleagues and/or onsite in San Diego. No role is expected to be 100% remote.

 Target Base Pay Range:
$150,000.00 – $195,000.00