Associate Medical Director
Company: Horizon Pharma
Location: South San Francisco
Posted on: June 8, 2021
Working at Horizon is more than a job - it's personal. For us,
success is measured by the numbers that matter most - the number of
lives we touch, the number we change and those we work tirelessly
to help save. We're a team of agile, out-of-the-box thinkers who
are inspired to do more because we know we're a part of something
bigger. We strive to build meaningful careers at a company whose
values we share because when we live up to our potential, we help
others live up to theirs.
- Member of Horizons clinical study team, contributing to the
design, analysis and reporting of clinical studies. Activities
include protocol writing, study conduct oversight according to best
practice and national and international guidelines and regulations,
as well as Horizon's objectives and standard operating procedures
- Data analysis support and data interpretation and presentation,
along with colleagues in statistics, PV-safety and regulatory
affairs to the development teams. Experience in collaboration with
statistics, safety and clinical operations is required.
- Work closely with the Clinical Development team leader to
ensure robust protocols and appropriate study oversight.
- Standing member of clinical trial team and safety review
- 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,
- Provide clinical-scientific input into key safety documents, as
- Provide guidance to managers before, throughout, and following
clinical trials to ensure compliance for proper study conduct
throughout clinical trials
- Review data from clinical trials, including ongoing review of
clinical trial safety data, laboratory data, ECGs, as required in
collaboration with PSPV colleagues; liaise with the clinical
development team and if requested with the Horizon Safety
- Review of non-clinical data as required.
- Review of clinical pharmacology data as required.
- Participate in evaluation of life cycle management
opportunities including assessment of adjacent indications,
assessment of investigator-initiated trial proposals, etc as
- Support development of medical affairs materials, based on
clinical trial datasets.
- Participate in due diligence activities as requested.
- Support team with setting up investigator meetings and advisory
boards with regards to presentation on clinical protocol or data to
Education & Professional Experience
- A degree in medicine with residency training completed.
- Demonstrated ability to work cross functionally in a matrixed
Horizon Core Values & Competencies:
- Manages Ambiguity
- Strategic Mindset
- Demonstrates Self-awareness
- Cultivates Innovation
- Develops Talent
- Drives Results
- Ensures Accountability
- Decision Quality
- Instills Trust
Horizon Therapeutics plc does not discriminate on the basis of
race, color, religion, gender, sexual orientation, national origin,
age, disability, veteran status, or any other characteristic
protected by law. It is our intention that all qualified
applications are given equal opportunity and that selection
decisions be based on job-related factors. Any individual, who,
because of a disability, needs accommodation or assistance in
completing this application or at any time during the application
process, should contact the Human Resources Department.
Keywords: Horizon Pharma, South San Francisco , Associate Medical Director, Other , South San Francisco, California
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