Director, Clinical Development

Employer
Rho, Inc.
Location
Research Triangle Park, NC
Posted
Oct 09, 2020
Required Education
Doctorate/PHD/MD
Position Type
Full time

Overview

Rho is currently looking for a Director, Clinical Development who will provide strategic and tactical leadership to projects and teams by developing viable and long-lasting solutions to cross-program, cross-functional, and organizational issues and initiatives.

Responsibilities

  • Serves as a key integrated product development expert at Rho, responsible for the full range of product development activities and services required to support the development programs and regulatory submissions of Rho’s clients, including gap analyses, strategic planning, development of integrated regulatory and clinical strategies and development plans, design of clinical studies, and authorship and review of study protocols, study reports, and regulatory submissions
  • On behalf of Rho’s clients, leads integrated pharmaceutical, biologic, and medical device product development programs consisting of clinical, preclinical, chemistry, manufacturing and controls, and regulatory components
  • Provides leadership, guidance, and support to a team, program, or project of large scope, as well as to the Program Management discipline within the company
  • Mentors and advises staff in areas of expertise by providing strategic and tactical guidance to team members, creating a strong sense of team unity and team identity, and providing regular and ongoing positive and corrective feedback to team members
  • Proactively identifies risks and critically analyzes problems affecting the programs
  • Develops contingency plans as needed
  • Facilitates achievement of strategic goals for a program
  • Monitors ongoing progress of key deliverables against Global Integrated Product Development Plan goals, including the identification of potential risks and contingency plans
  • Ensures effective, accurate and timely communication of key issues and progress to the team and Sr. Management
  • Manages the strategic, regulatory authorship, biostatistical, and data submissions components of regulatory submissions projects including INDs, IMPDs, IDEs, NDAs, BLAs, MAAs, and PMAs or portions thereof and is comfortable with all requirements related to electronic submissions
  • Authors Integrated Summaries of Safety, Integrated Summaries of Efficacy, and other complex regulatory documents
  • Develops and reviews clinical study protocols, investigator’s brochures, clinical study reports, and other key clinical development documents
  • Leads the planning, preparation, and conduct of regulatory authority meetings, and leads discussions with regulatory authorities as appropriate
  • Manages scope of work, budget, and timelines for external vendors, including consultants, external medical writers, preclinical toxicology houses, and other vendors as appropriate
  • Moderates regulatory authority meetings
  • Participates in business development activities, including assisting in the identification and assessment of new opportunities, representing Rho at conferences and meetings, and conducting capture activities for anticipated proposals
  • Serves as a proposal leader for commercial proposals with specific responsibility for the development and articulation of the technical strategy sections of the proposal
  • Provides guidance and input to the budgets and business submissions of proposals
  • Mentors other technical leads in business development and proposal creation activities

Qualifications

  • PhD/PharmD or equivalent demonstration of analytical ability and a minimum of twelve (12) years in development programs that include inter-related clinical, nonclinical, CMC and regulatory experience
  • Experience with FDA is required; experience with ex-US regulatory authorities (meetings, submissions, strategy) desired
  • Excellent written, verbal, and interpersonal communication skills and the ability to interact effectively with all levels both within and outside the company
  • Proven ability to establish credibility with professionals on program teams
  • Excellent regulatory intuition and project management acumen
  • Ability to understand and motivate others and build effective teams
  • Ability to proactively develop and foster constructive interactions among team members in order to address difficult situations, including resolving and negotiating conflicts or problems with tact, diplomacy, and composure
  • Excellent presentation and critical thinking skills
  • Ability to handle multiple projects and priorities with exceptional organizational and time management skills (both project and self)
  • Proficient in advanced techniques with relevant software: MS Project, Visio, Excel, PowerPoint, Word, etc. in addition to experience working within shared work environments 

EOE. Veterans/Disabled