Associate Medical Director, Clinical Development
Company: Horizon Therapeutics
Location: Oakland
Posted on: March 14, 2023
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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
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