Sr Director, Clinical Development

Location
Lake Forest, IL, United States
Posted
Aug 23, 2020
Ref
R0001862
Hotbed
BioMidwest
Required Education
Doctorate/PHD/MD
Position Type
Full time
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
  • Proficient in Microsoft Office. Professional, proactive demeanor.

Horizon Core Values & Competencies:

Growth
  • Manages Ambiguity
  • Strategic Mindset
  • Demonstrates Self-awareness
  • Cultivates Innovation
  • Develops Talent


Accountability
  • Drives Results
  • Ensures Accountability
  • Decision Quality


Transparency
  • Courage
  • Collaboration
  • 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.