Senior Director, Clinical Pharmacology

Clinical Dynamix, Inc.; South San Francisco (CA); Remote; USD 150,000 - 220,000; Full time

Job summary

A leading company in pharmaceuticals seeks a highly motivated Sr. Director of Clinical Pharmacology to lead the design of clinical studies and analyze pharmacokinetic data. This position involves oversight of clinical assets, interaction with multidisciplinary teams, and contribution to regulatory strategies. Ideal candidates possess a Ph.D. and extensive experience in Clinical Pharmacology, with strong analytical and leadership skills.

Qualifications

• 12+ years of experience in Clinical Pharmacology or equivalent.
• Strong background in interpreting clinical dose-response and PK/PD data.
• Neuroscience background preferred.

Responsibilities

• Oversee a portfolio of clinical assets and design Phase I studies.
• Perform, supervise, and report PK and PK/PD analyses.
• Contribute to regulatory documents (INDs, NDAs, etc.) and maintain drug development expertise.

Skills

Leadership

Collaboration

Communication

Education

Ph.D. in Pharmaceutics, Pharmacology, Pharmacokinetics or PharmD

Tools

WinNonlin

Phoenix NLME

NONMEM

Job description

Title : Sr. Director, Clinical Pharmacology

Reports to : SVP, Clinical Development

Location : US - Remote

Position Overview :

As Company continues to advance the development of our broad portfolio, we are seeking a highly motivated scientist to be responsible for designing clinical studies and performing, interpreting, and reporting Pharmacokinetic / Pharmacodynamic (PK / PD) results.

This individual will provide support in characterizing the clinical pharmacology profile of assets developed by Company as part of the overall pipeline. Specifically, the incumbent will support the pipeline by constructing, validating, and implementing disease, placebo, exposure response, and appropriate PK / PD models to evaluate risk / benefit and facilitate drug development decisions. Based on experience, this position could serve as a Clinical Pharmacology representative on study and project teams and will contribute to the planning, implementation and organization of regulatory filings along with presentation of PK / PD data to internal cross-functional teams and external collaborators. This position will report to the SVP of Clinical Development.

Responsibilities :

The successful candidate must be able to perform each of the following satisfactorily :

• Oversee and support a portfolio of clinical assets
• Design Phase I studies and collaborate with clinical teams (e.g. Clinical Operations, Research Bioanalytical scientists, Biometrics, and Clinical Development) to select the most appropriate PK sampling strategy for Phase II-III studies
• Perform, supervise, and report PK and PK / PD analyses for Company assets as they progress through clinical development
• Capable of integrating pharmacokinetic, pharmacodynamic, and safety data from multiple sources to optimize dosing for patient populations across the development continuum will be essential
• Interact with scientists, medical directors, and Technical Operations / Regulatory Affairs personnel for the timely completion of clinical studies and regulatory filings
• Participate in multi-disciplinary study teams and represent the function on project teams
• Contribute to protocol sections, analysis plans, study reports as well as regulatory documents (INDs, CTAs, NDAs, MAAs and Investigator's Brochure)
• Maintain and enhance technical and drug development expertise (e.g., training courses, external meeting attendance)
• Understand the legal and compliance environment and drive collaboration with the Legal and Compliance team
• Represent the Company Values in all interactions across all functions by supporting a team approach to focus on our patients and customers as our top priorities

Requirements :

Education and Experience :

Ph.D. degree or equivalent in Pharmaceutics, Pharmacology, Pharmacokinetics or PharmD with 12+ years of industry or equivalent experience in Clinical Pharmacology or similar background

Strong theoretical background and hands-on experience interpreting non-clinical and clinical dose-response and PK / PD data to inform clinical study designs and drug development decision-making is required

Neuroscience background strongly preferred

Proficiency with analysis software (e.g., WinNonlin, Phoenix NLME, NONMEM, or other commonly used platforms) strongly preferred

Prior experience in PK, PK / PD, and ADA of large molecules and / or vaccine therapeutics is preferred

Knowledge and experience with regulatory guidance related to clinical pharmacology

Competencies and Attributes :

Demonstrated leadership to drive results that are needed to achieve company objectives in accord with Company’s culture and values – courageous, imaginative, selfless and joyful

Ability to lead and work with others in a positive and collaborative manner

Proven ability to work independently, proactively, and effectively

Excellent oral and written communication skills and a proven track record of working effectively in a dynamic, integrated, team-oriented setting

Learning agility and 'scalability' to take on increasing responsibility as Company grows

Understanding the legal and compliance environment

Ability to have fun and thrive in a growing, diverse and inclusive work environment