Medical Director, Clinical Development

Company: Horizon Therapeutics
Location: Bethesda
Posted on: March 19, 2023

Job Description:

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. Responsibilities:Member of Horizon's clinical development team, leading and contributing to the design, analysis and reporting of clinical studies. Activities to include protocol writing, study conduct oversight including medical monitoring according to best practice and national and international guidelines and regulations, as well as Horizon's objectives and standard operating procedures (SOPs).Data analysis and data interpretation with data representation to internal and external (regulatory) audiences is a core skill set requirement. Experience in collaboration with statistics and clinical operations colleagues is required.Provide input into and review key internal and external reports such as Investigator Brochure, Risk Language, Informed Consent, study Protocols, study operations manuals, etc.Demonstrated ability to interact with study site investigators regarding subject eligibility, dosing, safety and other clinical trial conduct issues as needed.Contribute as needed to key safety documents, in collaboration with PSPV and regulatory colleagues including the PADER, PSUR, DSUR, etc.Provide clinical-scientific input into the development of Product Labels, core company data sheets (CCDS), Risk Evaluation and Mitigation Strategy and Risk Management Plans.Provide guidance to cross-functional colleagues before, throughout, and following clinical trials to ensure compliance for proper study conduct throughout clinical trialsReview data from clinical trials, including ongoing review of clinical trial safety data, laboratory data, ECGs, as required in collaboration with PSPV colleagues; liaise with Safety Data Monitoring Board, if applicableReview of non-clinical data as required.Review of clinical pharmacology data as required.Review of post-marketing safety data as required to inform label language and to support internal and external company reviews of the product safety profile.Participate in evaluation of life cycle management opportunities including assessment of adjacent indications, assessment of investigator initiated trial proposals, etc.Support development of medical affairs materials, based on clinical trial datasets.Education & Professional ExperienceA degree in medicine with at least 5 years of biotech/pharmaceutical experience in clinical development related activities.Demonstrated ability to work cross functionally in a matrixed environment.Our ValuesTransparency: 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 employeesEnterprise Mindset: Look beyond one's team, brand or function to see the broader company and external perspectiveExhibit Intellectual Curiosity: Seek to understand what you do not know; ask the right questions of the right people and sourcesEnsure Accountability and Courage: Step up to address difficult issues and hold self and others accountable to commitmentsEmbrace Diverse Perspectives: Welcome others with a respectful attitude; integrate diverse perspectives into ways of workingDevelop Talent: Provide feedback, coaching and mentorship to help others be more effective in their roleAt 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, Bethesda , Medical Director, Clinical Development, Executive , Bethesda, Maryland