Sr. Director, Pharmacokinetics, Drug Disposition and Clinical Pharmacology

Glaukos Corporation•Aliso Viejo, CA

About The Position

The Senior Director of Pharmacokinetics, Drug Disposition and Clinical Pharmacology within the Applied Research Department at Glaukos is responsible for leading the functional areas of Pharmacokinetics (PK), Pharmacodynamics (PD) and Drug Disposition, Nonclinical Drug Metabolism, Bioanalysis, PK, PK/PD modeling and Clinical Pharmacology. This role will also be responsible for leading the transition of ophthalmic drug and drug discovery research into clinical development programs. Serves as a Subject Matter Expert in the area of PK and Drug Disposition, leading the PK, PK/PD, bioanalysis for small and large molecules, immunogenicity assessments and clinical pharmacology discipline areas and teams. Conceives and executes translational strategies to support advancing discovery projects into clinical development programs, providing the link between early research and clinical development. Develops relevant models for assessment of PK/PD to ensure robust decision making on developability of drug molecules and formulations in all ophthalmic therapeutic areas of interest. Develops nonclinical testing strategies in collaboration with Pharmacology and Toxicology, CMC and Drug Delivery Innovation to support the research and development activities to enable regulatory submissions for INDs and NDAs. Oversees the development and validation of bioanalytical assays for assessments of small molecule PK, PD utilizing relevant biomarkers and immunoassays for biologics PK and immunogenicity assessments. Provides critical input to clinical study designs (i.e.; based on efficacious human dose projections) and leads the clinical pharmacology studies. Applies various approaches and strategies to predict human PK parameters from analysis of nonclinical data and assess PK/PD properties of drug candidates based on preclinical data. Authors clinical and nonclinical PK sections for regulatory submissions and clinical investigator brochures Oversees the development of detailed work plans and study designs to incorporate quantitative, objective end points into PK/tolerability and PK/PD studies to demonstrate target engagement, pharmacodynamic regulation of pathways of interest, modulation of pharmacologic mechanism and information to aid patient selection, manages the budget for the PK-DD- Clin Pharm functional line. Works in close collaboration with the formulation development, drug delivery and pharmaceutical development teams, providing critical feedback based on drug disposition and target engagement data. Evaluates and manages external contract research organizations (CROs) directly and via direct reports. Supervises direct reports, including PhD levels and provides mentoring and career development support Defines the long term strategy for the establishment of Pharmacokinetic, Drug Disposition and Clinical Pharmacology Organization at Glaukos and builds the team as the company evolves.

Requirements

Broad understanding of pharmacokinetics and PK/PD modeling strategies and hands on experience with PK and PK/PD modeling tools (i.e. Phoenix/Winonlin, NonMem)
Experience in analyzing and reporting nonclinical PK study data and human PK from clinical trials
Effective written and verbal communication skills; strong understanding of regulatory environment to support regulatory and corporate agencies
Experience in writing sections 2.4 and 2.6 of CTDs
Excellent analytical and conceptual thinking abilities, forward-looking.
Solves business problems using creativity, collaboration, and communication.
Strong scientific and leadership skills with the ability to be a subject matter expert at matrix teams and influence and collaborate.
Proven history of building relationships and fostering engagement across multiple stakeholders, including senior management, operators, suppliers and business partners
A track record of inspiring and aligning organizations around goals and contributing as an active role model for company values.
Nurtures a culture of engagement, respect, and high performance within a team environment.
Provides leadership, coaching and feedback; mentors, develops and empowers team members
Ability to work and lead effectively within a diverse workforce
Active scientific participation and collaboration with colleagues in industry, academia and regulatory agencies
Experience collaborating with biologists and chemists to generate in vivo target validation data and establishing PK/PD and biomarker correlations
Experience identifying relevant translational disease models and applying them to meet program goals
Multiple examples of partnering with drug discovery to identify and develop candidates
Strong track record of meeting and exceeding goals.
Sound business acumen with a practical, results-oriented leadership style that can translate innovative, creative strategies into action plans
Demonstrated high level of integrity and ethics
University degree and PhD in DMPK or related field and 15+ years’ pharmaceutical industrial experience or an equivalent combination of education and experience.

Nice To Haves

Ophthalmic drug development experience is highly desired

Responsibilities

Leading the functional areas of Pharmacokinetics (PK), Pharmacodynamics (PD) and Drug Disposition, Nonclinical Drug Metabolism, Bioanalysis, PK, PK/PD modeling and Clinical Pharmacology.
Leading the transition of ophthalmic drug and drug discovery research into clinical development programs.
Serving as a Subject Matter Expert in the area of PK and Drug Disposition, leading the PK, PK/PD, bioanalysis for small and large molecules, immunogenicity assessments and clinical pharmacology discipline areas and teams.
Conceiving and executing translational strategies to support advancing discovery projects into clinical development programs.
Developing relevant models for assessment of PK/PD to ensure robust decision making on developability of drug molecules and formulations.
Developing nonclinical testing strategies in collaboration with Pharmacology and Toxicology, CMC and Drug Delivery Innovation to support research and development activities for regulatory submissions.
Overseeing the development and validation of bioanalytical assays for assessments of small molecule PK, PD utilizing relevant biomarkers and immunoassays for biologics PK and immunogenicity assessments.
Providing critical input to clinical study designs and leading clinical pharmacology studies.
Applying various approaches and strategies to predict human PK parameters from analysis of nonclinical data and assess PK/PD properties of drug candidates.
Authoring clinical and nonclinical PK sections for regulatory submissions and clinical investigator brochures.
Overseeing the development of detailed work plans and study designs to incorporate quantitative, objective end points into PK/tolerability and PK/PD studies.
Managing the budget for the PK-DD- Clin Pharm functional line.
Working in close collaboration with formulation development, drug delivery and pharmaceutical development teams.
Evaluating and managing external contract research organizations (CROs).
Supervising direct reports, including PhD levels and providing mentoring and career development support.
Defining the long term strategy for the establishment of Pharmacokinetic, Drug Disposition and Clinical Pharmacology Organization at Glaukos and building the team.