Associate Medical Director, Clinical Development

Company: Horizon Therapeutics
Location: Oakland
Posted on: March 14, 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. Company: Horizon Therapeutics USA, Inc.Location: Two Tower Place, 12th Floor, South San Francisco, CA 94080Position Title: Associate Medical Director, Clinical Development Salary: $202,500 - $247,500 / Year Hours: Monday - Friday, 8:00 am to 5:00 pm, 40 Hours/ WeekSummary of Duties: Work with clinical study teams, contributing to the development, design, analysis, and reporting of pharmaceutical industry clinical studies. Work with pharmaceutical industry global clinical trial management. Perform clinical trial protocol writing. Study conduct oversight according to best practice and national and international guidelines and regulations. Study objectives and standard operating procedures (SOPs). Provide Data analysis support, data interpretation and presentation, working with member in statistics, Pharmacovigilance (PV)-safety and regulatory affairs, to the broader internal development teams. Use knowledge of and experience working in industry with statistics, safety and clinical operations. Work with the Clinical Development team leader to ensure protocols are developed and conducted with appropriate study oversight. Provide input into and review key internal and external reports, such as Investigator Brochures, Risk Language, Informed Consents, Study Protocols, and study operations manuals. Work with study site investigators regarding subject eligibility, dosing, safety and other clinical trial conduct issues as needed. Use knowledge and experience with key safety documents, in collaboration with PSPV and regulatory colleagues, for example the PADER, PSUR, DSUR, etc. Provide guidance to managers before, throughout, and following clinical trials to ensure compliance for proper study conduct. Review data from clinical trials, including ongoing review of clinical trial safety data, laboratory data, electrocardiograms, as required in collaboration with Patient safety and pharmacovigilance (PSPV) colleagues; liaise with the broader clinical development team and if requested with Safety Committees. Review non-clinical data and clinical pharmacology data as required. Evaluate life cycle management opportunities including assessment of adjacent indications, assessment of investigator-initiated trial proposals as requested. Support development of medical affairs materials, based on clinical trial datasets. Use knowledge and experience with the following: Drug development; developing clinical trial design concepts; protocol writing; Good Clinical Practice (GCP) and International Conference on Harmonization (ICH); and work cross functionally in a matrixed environment.Qualifications: The position requires a Doctor of Medicine degree, M.D., or an equivalent degree in a related field and 3 years of experience in job offered or as a Clinical Research Associate, Clinical Trial Manager, or a related occupation.The position requires 3 years of experience with the following: Managing global clinical trials and clinical study protocol; Contributing to the design, analysis, and reporting of pharmaceutical industry clinical studies; Good Clinical Practice (GCP) and International Conference on Harmonization (ICH); Study monitoring as per SOP, protocol, ICH GCP, and US FDA guidelines; Development and review of study related documents including protocol, informed consent forms (ICF), standard operation procedure (SOP), product manuals, training materials, and clinical studies reports; Electronic Data Capture (EDC) management and maintenance; Case Report Form (CRF) design and data listing; The position requires experience with the following: Clinical supporting the development of therapeutic solutions; Trial Master File (TMF) management, vendor management, CRO management; and Evaluating and reporting Adverse event / Serious event (AE/SAE).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 roleCompensation 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: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, Oakland , Associate Medical Director, Clinical Development, Executive , Oakland, California