Sr Director, Clinical Development

Company: Horizon Therapeutics plc
Location: Lake Forest
Posted on: September 12, 2020

Job Description:

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.

Position Summary:

The Senior Director of Clinical Development will be responsible for overseeing internal and external activities associated with advancement of our rare and orphan portfolio. This person will play an active role on cross-functional program teams; this includes planning development strategies and interpreting data, as well as making hands-on contributions while managing vendors. Primary responsibilities surround the development of clinical development plans as well as trial-level design and execution (eg, protocol development) for drug candidates. The selected individual will be contributing to IND/NDA/CTA/ MAA submissions.

Responsibilities:

Accountable for the design and execution of clinical development plans and phase 1-4 clinical trials within that plan, working with a cross-functional team (eg, regulatory, statistics, clinical operations)

Responsible for authoring or contributing to synopses, protocols, regulatory and ethics responses, site inquiries

Represent the clinical development function on project development teams

Identify relevant external experts and attain scientific and clinical insight for potential new indications

Participate in scientific evaluation and due diligence activities as part of our active business development efforts

Represent Horizon Therapeutics and the Clinical Development function at regulatory meetings, medical meetings, advisory boards, and other venues

Participate in preparation of preclinical and clinical study protocol designs, preclinical and clinical study reports, and investigator brochures.

Author high quality regulatory documents including contributions to INDs, CTAs and NDA/BLA filings.

Maintain current awareness in area of expertise, prepares abstracts and manuscripts for scientific publications/presentations.

Other duties as required

Qualifications and Skills Required:

Advanced degree in medicine or related discipline (PhD, PharmD, MD); MD preferred

Ability to provide strategic direction and guidance to teams aligned with clinical development plans

Ability to develop clinical trial design concepts, contribute to protocol writing

In depth knowledge of GCP and ICH

Anticipates new trends in a competitive landscape and therapeutic areas to guide the organizational strategy

Strong analytical skills with a data driven approach to planning, executing, and problem solving

Excellent communication and interpersonal skills and the ability to facilitate constructive, expedient problem solving

10 years relevant industry experience, preferably with drug development

Effective communication skills to all levels of the organization

Proactive and self-disciplined, ability to meet deadlines, effective use of time, and prioritization

Accomplished influencing and negotiation skills

Ability to build successful and effective teams and collaborations internally as well as with external partners

Horizon Core Values & Competencies:

Growth

Manages Ambiguity

Strategic Mindset

Demonstrates Self-awareness

Develops Talent

Accountability

Drives Results

Ensures Accountability

Decision Quality

Transparency

Courage

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.

Posted 15 Days Ago

Full time

R0001862

About Us Horizon is focused on researching, developing and commercializing medicines that address critical needs for people impacted by rare and rheumatic diseases. Our pipeline is purposeful: we apply scientific expertise and courage to bring clinically meaningful therapies to patients. We believe science and compassion must work together to transform lives. For more information on how we go to incredible lengths to impact lives, please visit follow us @HorizonNews  on Twitter, like us on Facebook  or explore career opportunities on LinkedIn .

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Keywords: Horizon Therapeutics plc, Lake Forest , Sr Director, Clinical Development, Other , Lake Forest, California