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Job Details

Executive Director, Clinical Regulatory Consultant-135745

Company: PPD
Location: Europe, Middle East & Africa-UK-England-Cambridge
Reference: 135745
Closing Date: 11 Dec 16
Type: Full Time
Salary (£): On Application
Benefits:

Job Summary:

We are seeking an Executive Director to join our global PPD Consulting group in the EMEA region as Clinical Regulatory Consultant. This is primarily for the therapeutic areas of gene therapy and rare disease.The role can be office or home based in any of the European countries where PPD has an office.PPD are seeking a candidate based in the EMEA region to join the Global Product Development team. ...

Requirements:

We are seeking an Executive Director to join our global PPD Consulting group in the EMEA region as Clinical Regulatory Consultant. This is primarily for the therapeutic areas of gene therapy and rare disease.

The role can be office or home based in any of the European countries where PPD has an office.

PPD are seeking a candidate based in the EMEA region to join the Global Product Development team. The position can be based at any of our EMEA offices or home based (in a country when PPD has an office). It is a permanent in-house role.

The successful candidate will serve as PPD’s senior European regulatory strategic lead and provide advice to clients on strategic regulatory considerations for non- clinical and clinical (I - IV) product development and study designs. They will advise on product competitive benchmarking, such as review of relevant regulatory precedents for evolving standards; product label key messaging and rigorous regulatory review for successful registration. They will also provide strategic assessment, impact analysis and business inflection points for the client assets and develop target product profiles and key messaging for product labelling to support product critical regulatory development milestones to enable approvable investigational and marketing applications.

Key responsibilities

  • Provides client program and/or portfolio oversight and senior level regulatory review/editing for NDA/BLA CTD Module 2 biopharmaceutics, clinical pharmacology and clinical efficacy and safety summaries and Module 5 CSR/ISE/ISS key messaging.
  • Expertly facilitates client and regulatory agency interfaces.
  • Provides leadership and oversight to a small clinical regulatory team.
  • Plays an active role in business development to expand portfolio of standalone regulatory and cross functional consulting projects.
  • Develops and executes on thought leadership strategy related to European regulatory advising.
  • Maintains up-to-date knowledge and understanding of PPD SOPs, relevant client SOPs/directives, and current regulatory guidelines as applicable to services provided
  • Establishes strategy and direction for assigned areas in alignment with strategic plans established by senior management.
  • Broad function-wide objectives and assignments are established under the general senior management direction and guided by approved operating plans. Work is reviewed upon completion for meeting timelines, adequacy, and objectives. 
  • Develops and manages interpersonal relationships to influence decisions of senior leaders both within and outside of the company.

Qualifications

  • Advanced degree (PhD, PharmD, MD or MS) required
  • 15 years of clinical regulatory experience in the pharmaceutical industry with a demonstrated record of career advancement and drug development accomplishments; Previous team management experience preferred
  • A focus in either Gene Therapy or Rare Diseases and tangible achievements in other therapeutic areas
  • Experience as a consultant desired but not required
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.    
  • Significant knowledge of and experience with European Phase I - III regulatory requirements and broad knowledge of U.S. regulatory requirements with proven track record of successful negotiations with EMA and NCAs
  • Ability to write regulatory submissions from source documents
  • Trained in GCP and other GXP regulations and demonstrated ability to train others
  • Ability to manage multiple projects, external consultants and CRO’s
  • Demonstrated understanding of the drug development process
  • Excellent communication and interpersonal skills and a track record of working effectively in matrixed teams
  • Ability to build and implement a cohesive business plan and strategy
  • Strong decision-making and analytical skills

*LI_EC1


Apply for this job: Executive Director, Clinical Regulatory Consultant-135745

Contact Information:

Address:  PPD Cambridge
Granta Park
Great Abington
Cambridge

CB21 6GQ
England
Tel:  +44 1223 374100
Website:  Visit Our Web Site

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