Associate Director, Clinical Pharmacology

Company: Horizon Therapeutics
Location: Daly City
Posted on: May 20, 2023

Job Description:

At Horizon Therapeutics, we define success by the number of lives touched, lives changed, and lives saved. Our global biotechnology company is made up of agile, out-of-the-box thinkers with a focus on delivering breakthrough medicines to those living with rare, autoimmune, and severe inflammatory diseases. This is the heart of our global mission. Start a career that enables you to live up to your potential and help others live up to theirs. Join us.
The exceptional support we provide patients and communities equally extends to our employees. We offer industry-leading and award-winning benefits, compensation and rewards programs that positively impact all areas of our employees' personal and professional lives.
Position Summary:
As an associate director of Clinical Pharmacology and DMPK, you'll play an important role in all phases (discovery, preclinical and clinical) of drug development to provide strong technical support for clinical pharmacology and DMPK function. Support DMPK and clinical pharmacology for molecules at preclinical and clinical development stage and act as subject matter expert for clinical pharmacology and DMPK on multidisciplinary teams.
Responsibilities:

• Support DMPK and clinical pharmacology for molecules at preclinical and clinical development stage with minimum guidance from manager and act as subject matter expert for DMPK and clinical pharmacology on multidisciplinary teams
• Responsible for study design and data interpretation of clinical pharmacology studies, including pharmacokinetics, pharmacodynamics, food effect, relative bioavailability, drug-drug interaction, QTc, and special population studies
• Review and/or conduct non-compartmental and population PK, PK/PD, and exposure-response analysis to support key program decision-making (eg, phase 2/3 dose selection)
• Author clinical and regulatory documents related to clinical pharmacology components, including protocols, investigator brochures, study reports, briefing documents for regulatory meetings, and NDA/BLA; author scientific publications
• Represent clinical pharmacology in regulatory interactions (eg, pre-IND, EOP2, pre-NDA/BLA)
• Present scientific results to internal and external stakeholders
• Collaborate with toxicologist and preclinical pharmacology scientists to design, conduct, and report preclinical PK and translational PK/PD studies to support candidate selection and IND filing, including human PK prediction to support starting dose and dose escalation schemes for first-in-man studies
• Oversee and work closely with collaborators and CROs in study protocol/report review for both preclinical and clinical studies
  Qualifications and Skills Required:
  
  • PhD or equivalent experience in Pharmacokinetics, Pharmacometrics, Pharmaceutical Sciences, or other related disciplines.
  • 5 years of industry or equivalent experience in PKPD, clinical pharmacology, and/or pharmacometrics (DMPK experience is a plus).
  • Proficiency in mathematical modeling and programming as demonstrated by hands-on experience in computational tools (e.g. R, NONMEM)
  • Demonstrated ability to work in a highly collaborative, multi-disciplinary team setting.
  • Excellent verbal and written communication skills
  • Self-directed and highly motivated researcher, with willingness to learn new tools and approaches
  • Professional, proactive demeanor
  • # LI-REMOTE
    Our Values
    
    • Transparency: We value collaboration. Trusting teach other and tackling tough challenges can make a powerful difference.
    • Accountability: We do what's right for our patient communities through quality decisions and owning our successes and failures.
    • Growth: We fiercely innovate and evolve to better ourselves, our communities and our patients.
      These three values come to life through our five Leadership Expectations that apply to all Horizon employees
      
      • Enterprise Mindset: Look beyond one's team, brand or function to see the broader company and external perspective
      • Exhibit Intellectual Curiosity: Seek to understand what you do not know; ask the right questions of the right people and sources
      • Ensure Accountability and Courage: Step up to address difficult issues and hold self and others accountable to commitments
      • Embrace Diverse Perspectives: Welcome others with a respectful attitude; integrate diverse perspectives into ways of working
      • Develop Talent: Provide feedback, coaching and mentorship to help others be more effective in their role
        Compensation and Benefits Summary:
        The salary range for this role is $166,500.00-$203,500.00 annually. The base salary offered may vary based on the final candidate's qualifications. The level of this role may also change based on the final candidate's qualifications.
        In addition to the salary, this position is eligible for the benefits listed here and for the following plans:
        Salary Plan, Annual Merit Plan, Annual Equity Grant, New Hire Equity Grant, Corporate Bonus
        At Horizon, we know that disease does not discriminate. We embrace the bold ideas of one another, foster a sense of belonging, and value inclusion. We attract and develop diverse talent because we believe that when people from different backgrounds and life experiences come together, we make lives better.
        Horizon intends that all qualified applications are given equal opportunity, and that selection decisions be based on job-related factors. We do not discriminate based on race, color, religion, gender, sexual orientation, national origin, age, disability, veteran status, or any other characteristics protected by law.

Keywords: Horizon Therapeutics, Daly City , Associate Director, Clinical Pharmacology, Executive , Daly City, California