Director / Senior Director, Product Development - Transplantation 8/18/2016

United Therapeutics Durham, NC

Company
United Therapeutics
Job Classification
Full Time
Company Ref #
28863714
AJE Ref #
575921114
Location
Durham, NC
Job Type
Regular

JOB DESCRIPTION

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POSITION OVERVIEW

The Director/Senior Director, Product Development is responsible for developing and executing all aspects (CMC, preclinical, clinical, manufacturing, QA, post-marketing) of the development of a product or products to ensure the successful submission and approval by the FDA and other regulatory agencies. This is a hands on position, requiring and the knowledge required to implement and oversee advanced clinical trials, and set the strategy for regulatory submission. This person will have full responsibility for the content of all regulatory submissions for the given product.

KEY ACCOUNTABILITIES / RESPONSIBILITIES

* Provide cross-functional and matrix leadership to project team, ensuring strategic planning, design, conduct, analysis and reporting of clinical trials and maintains scientific merit and regulatory compliance, leading up to product approval
* Manage all project planning, including timelines, budgets, and resourcing
* Act as the key point of contact with Steering Committees, Advisory Committees, Data Monitoring Committees, and Publication Committees
* Organize and manage all aspects of preclinical or clinical studies alone or in conjunction with a preclinical scientist, clinical or senior clinical research scientist, study manager, and/or clinical research associates
* Provide scientific insight into study design
* Develop and write clinical protocols and Investigator's Brochures
* Participate with clinical team in planning & conduct of investigator meetings, advisory boards, and other clinical/scientific interactions
* Responsible for selection of clinical sites/CRO, development
* Demonstrated understanding of the overall drug development process with clinical trial design, study implementation, sponsor/site interactions, scientific and clinical methodology, protocol design, project management and regulatory requirements for clinical studies to be reviewed by Health Authorities
* 10+ years of full life cycle product development experience - 6 + years hands on experience managing across phase 1-4 clinical trials as well as registration trials
* Thorough knowledge of GCP, ICH and PhRMA Guidelines
* Thorough knowledge of relevant FDA regulations and guidelines; demonstrated experience interacting with FDA personnel; knowledge of EU regulations and guidelines a plus
* Ability to travel as required, typically around 25%

PREFERRED KNOWLEDGE, SKILLS, AND ABILITIES

* Previous experience with transplantation studies or other related indications strongly preferred
* Previous experience successfully managing/progressing a product from clinical trial through the regulatory approval process to commercialization strongly preferred
* Strong communication (oral and written), presentation, and analytical skills
* Ability to work independently, prioritize tasks efficiently and meet expected time frames
* Ability to interact collaboratively with various departments, regulatory agencies and investigators
* Proficiency with Microsoft Office products

United Therapeutics Corporation is an Equal Opportunity/Affirmative Action Employer - EOE Minorities / Females / Protected Veterans / Individuals with Disabilities