Director, Clinical Pharmacology

Company: Horizon Therapeutics
Location: Waukegan
Posted on: May 21, 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 The Director, Clinical pharmacology and DMPK will be responsible for overseeing internal and external activities supporting the preclinical DMPK and clinical pharmacology of multiple programs in the corporate portfolio. This person will play an active role on cross-functional program teams; this includes planning development strategies and interpreting data, as well as making hands-on contributions while managing vendors. The selected individual will be responsible for the DMPK and clinical pharmacology sections for IND/NDA (or BLA)/CTA/MAA submissions. This person will interface closely with various other functions to ensure timely cross-functional information sharing of key DMPK and clinical pharmacology aspects of the program. This position will also help with stage-appropriate diligence evaluations of external opportunities Responsibilities Manage a team of clinical pharmacologists Responsible for the design and execution of clinical pharmacology strategy for multiple programs Serve as a key source of scientific expertise for the study design, analysis, reporting, and presentation of pharmacokinetic (PK), PK/pharmacodynamic (PD), and exposure-response data Prepare and implement strategic and scientifically sophisticated DMPK and clinical pharmacology plans for drug development that meet regulatory requirements and program goals Responsible for the study design, analysis, interpretation, and reporting of preclinical DMPK and clinical pharmacology data Design and implement Model Informed Drug Development (MIDD) strategy for various programs. Drive PK and PK/PD modeling support to both preclinical and clinical project teams for key DMPK and clinical pharmacology deliverables Support DMPK and clinical pharmacology components of preclinical and clinical study design, protocol development, data analysis and reporting Prepare verbal and written summaries for internal discussions and author high quality regulatory documents including IND/CTA/NDA/BLA/MAA filings Represent clinical pharmacology in regulatory interactions (eg, pre-IND, EOP2, pre-NDA/BLA) Participate in the management of CROs and academic sites in the conduct of in vitro/in vivo DMPK studies Partner with and support research, toxicology, bioanalytical sciences, clinical development, regulatory, project management and other departments Participate in external business development Maintains current awareness in area of expertise, prepares abstracts and manuscripts for scientific publications/presentations Qualifications and Skills Required Ph.D. in Pharmacokinetics, pharmacometrics, pharmaceutical sciences, DMPK or related disciplines with thorough knowledge of clinical pharmacology, DMPK, and pharmacometrics Minimum 6-8 years of pharmaceutical industry experience including PKPD, clinical pharmacology, and/or pharmacometrics (DMPK experience is a plus) Thorough understanding of regulatory strategies and guidelines. Strong experience in regulatory filings and interactions with regulatory authorities worldwide Proficiency in mathematical modeling and programming as demonstrated by hands-on experience in computational tools (e.g. Phoenix WinNonlin, R, NONMEM) Leadership, project management skills, and experience with managing external vendors Excellent communication and interpersonal skills and the ability to facilitate constructive, expedient problem solving Professional demeanor Self-starter attitude 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 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 $202,500.00-$247,500.00 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.

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