Senior Medical Director, Clinical Development
Company: Horizon Therapeutics
Location: Silver Spring
Posted on: May 24, 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.
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 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 Safety Data
Monitoring Board, if applicable
- Review 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 Experience
- A 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 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 $279,000.00-$341,000.00 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.
Keywords: Horizon Therapeutics, Silver Spring , Senior Medical Director, Clinical Development, Healthcare , Silver Spring, Maryland
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