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Director, Regulatory and Strategic Development (Home Based)

Company: Clinipace
Location: Boulder
Posted on: June 13, 2019

Job Description:

Clinipace is a global full-service clinical research organization (CRO) serving the unique needs of venture-backed, mid-tier and strategic pharmaceutical, biotechnology and medical device firms. We help our customers advance drug candidates to deliver successful stakeholder and patient outcomes. We leverage extensive therapeutic knowledge, clinical trial expertise, and comprehensive innovative technology to support life science firms in achieving some of their most important goals: Executing regulatory strategies, optimizing clinical development timelines and completing high quality trials. We are proud to have a culture that is vibrant, supportive, performance-driven, and passionate while focusing on continual learning and development. Clinipace associates are passionate about their lives and bring that same passion to their work at Clinipace.

Work Location: United States - Colorado (Boulder) Job Code: 4140 Description Job Title: Director, Regulatory and Strategic Development (Biologics)

Job Location: Boulder, Colorado or USHome-based

Job Overview:

A Director of Regulatory and Strategic Development will be responsible for the primary delivery of or oversight and management of allocated projects including regulatory authority licenses, registrations, exemptions, designations, applications or authorizations for marketing and sale of a drug product or for the use of an investigational drug in human subjects. This position will develop regulatory plans and strategies for emerging and mid-tier life science client companies. The position will include client and regulatory authority liaison and requires excellent technical and verbal and written communication skills. The position may include the supervision and management of regulatory professionals and support personnel.

Job Duties and Responsibilities:

  • Prepare technical content for and review of regulatory documentation and submissions.

  • Provide regulatory guidance internally to project teams, functional areas and externally to clients.

  • Develop client regulatory plans including timelines, submission documentation, communication, and reporting and tracking of regulatory deliverables.

  • Develop and maintain regional and/or global strategic plans for the development of client drug product.

  • Establish and direct cross-functional teams of internal and external personnel to deliver client projects.

  • Oversight of the compilation and review of regulatory documentation and submissions ensuring quality, timeliness and within budget delivery of regulatory tasks.

  • Conduct and participate in meetings with regulatory authorities.

  • Liaise with regulatory authorities, clients, contractors, consultants and vendors.

  • Represent client in regulatory authority meetings, and in meetings with client partners, investors, collaborators, consultants and others.

  • Oversee timeliness, quality, communication, and within budget deliverables provided by any contracted regulatory consultants.

  • Provide training for internal personnel and supervise staff, as required.

    Supervisory Responsibilities: Directly supervises employees if required. Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring and training employees; planning, assigning and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

    Job Requirements:

    • Education

      • ---Bachelors' degree in area of concentration commensurate with responsibility.

        • Post-graduate degree and leadership role in academia or in pharmaceutical industry highly desirable.

        • Experience

          • 10+ years' work experience commensurate with functional area of responsibility; or combination of work experience, education or other related industry experience in similar role.

          • Experience working in the CRO/ Consulting environment within life sciences

          • Must have taken different clients to the FDA/ possess exposure of presenting directly to the FDA on behalf of clients

          • Expertise in all stages of regulatory affairs within Clinical Research

          • Marketing operations experience is a must (NDAs, INDs)

          • Strong biologics background strongly preferred

          • Skills/Competencies

            • Oral communication: Speaks clearly and persuasively in positive or negative situations, demonstrates group presentation skills and conducts productive meetings.

            • Safety and security: Observes safety and security procedures and uses equipment and materials properly.

            • Quality management: Looks for ways to improve and promote quality and demonstrates accuracy and thoroughness.

            • Problem solving: Identifies and resolves problems in a timely manner and gathers and analyzes information skillfully.

            • Planning/organizing: Prioritizes and plans work activities, uses time efficiently and develops realistic action plans.

            • Analytical: Synthesizes complex or diverse information.

            • Judgment: Displays willingness to make decisions, exhibits sound and accurate judgment and makes timely decisions.

            • Mentor/Teacher: Demonstrates a willingness to organize and explain complex regulatory or compliance concepts. Has made the growth and development of others a priority.

            • Communicator: Is observed to share information positively, accurately and effectively with others. Naturally keeps others informed. Effective communicator both written and verbal to project team members, cross functionally, to regulatory consultants and to clients.

            • Facilitator: Has history of helping diverse groups accomplish goals in a positive manner. Naturally makes other's job easier.

            • Capabilities

              • Excellent written and verbal communication skills. Excellent interpersonal skills. Strong computer skills, including Microsoft Office.

                #LI- MMM

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Keywords: Clinipace, Denver , Director, Regulatory and Strategic Development (Home Based), Executive , Boulder, Colorado

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