Director Clinical Development Jobs in Ladera Ranch, CA

How You'll Make an Impact: 

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.

  What You'll Bring: 

• 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)
• Ophthalmic drug development experience is highly desired
• 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.

  This leadership role works onsite in Aliso Viejo, CA headquarters  Monday - Friday. 

  #GKOSUS
   

Generous. Innovative. Leadership-driven. Family-oriented. Socially responsible. 

Founded in 1998, Glaukos Corporation is an ophthalmic pharmaceutical and medical technology company focused on developing and commercializing novel therapies for the treatment of glaucoma, corneal disorders, and retinal diseases.

Our mission at Glaukos is to truly transform vision by pioneering novel, dropless therapies that can meaningfully advance the standard of care and improve the lives of patients suffering from chronic, sight-threatening eye diseases. 

Innovation is at the core of everything we do, and we are resolute in our commitment to challenge conventional thinking with new treatment alternatives that are supported by real science, robust clinical evidence, and an unrelenting focus on patients. 

Our constant pursuit of game-changing technologies that disrupt legacy treatment paradigms is encapsulated in the Glaukos mantra "We'll Go First," which articulates our willingness to take chances, our determination to forge new ground, and our commitment to continuous improvement in all that we do.   

Our company completed an initial public offering in June of 2015, and our shares are traded on the New York Stock Exchange under the ticker symbol "GKOS". Our global headquarters is in Aliso Viejo, California with additional locations in San Clemente, California, and Burlington, Massachusetts.

Glaukos Corporation is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law. 

All offers of employment are contingent upon the successful completion of a background check, including successfully passing a drug screen, based on the position and local regulations.