Diligence Lead

Diligence Lead

Job Introduction

  • The Diligence Lead will perform governance, leadership and facilitation duties to support triage / pre-diligence of potential in-licensing opportunities, and the planning / conduct of International Diligence projects.
  • Under the oversight of the Executive Director, Diligence, and in collaboration with Business Development Leads and appropriate Licensing Leadership Team members, the Diligence Lead will facilitate the triage of potential in-licensing opportunities and coordinate the initial pre-diligence of progressed opportunities.
  • For opportunities authorised as progressing to diligence, the Diligence Lead will schedule and coordinate diligence meetings, set the strategy for diligence reviews, communicate assignments and expectations to team members, and coordinate the completion of all diligence related activities to ensure appropriate quality, integrity and completeness. The Diligence Lead, will consolidate review-specific information and communication documents to ensure the coordination of deliverables. The Diligence Lead will ensure senior management, Board member and additional stakeholder review materials are compiled and available in a timely manner.

Location

Cambridge (UK)

Start Date

As Soon As Possible

Main tasks

  • Responsible for leading International Diligence teams in partnership with the Executive Director, Diligence, and responsible for defining diligence requirements, responsible for setting and communicating diligence strategy, conducting and completing reviews on time and to the appropriate level of quality.
  • Utilise superior project management expertise, leadership skills and techniques, and pharmaceutical-scientific intellect in the coordination and governance of diligence reviews.
  • Liaise with Business Development Leads for coordination of triage and pre-diligence reviews, engaging with appropriate functional representatives to determine the rationale for progression or early termination.
  • Within the scope of diligence reviews, establish and lead cross functional diligence teams in the assessment of scientific consideration (mechanism of action), medical/clinical, technical and regulatory development, including assessment of intellectual property considerations, the manufacturing, testing and supply of pharmaceutical products.  The Diligence Lead will also coordinate the Corporate, Legal and Financial diligence review of Third Parties.
  • Develop robust communication pathways for matrix team members and stakeholders, design relevant presentation and reporting templates, create appropriate presentation drafts, review/edit/maintain diligence deliverables (including, but not limited to, reports and Board of Director meeting materials), and create/maintain the diligence project information repository.
  • Demonstrate an expertise in all aspects of clinical & pharmaceutical development, including assessment of regulatory strategies, clinical trial quality and manufacturing/testing of new drugs and drug products with consideration to compliance with current International guidelines (e.g. GLP, GMP, and GCP).
  • Liaise with external third parties to facilitate transfer of diligence materials, phone conferences, potential face to face meetings and manufacturing site assessments on pharmaceutical and clinical development opportunities.
  • Ensure diligence reviews are effectively planned and well-organised, covering the entire geographical region(s) of interest (Europe and Latin America, Asia Pacific, Middle East and Africa).
  • Utilise analytical processes, team building and motivational skills to organise resources and develop/communicate diligence project plans, timelines and deliverables.
  • Manage the information relating to projects including the development and maintenance of diligence information hubs on R&D SharePoint and ensuring the smooth flow of information within the diligence team.
  • In partnership with the Executive Director, Diligence Manager and appropriate matrix team members, facilitate the development and maintenance of Integrated Development Plans, Target Product Profiles, development resource workbooks, and additional diligence related documentation.
  • Deputises for the Executive Director, Diligence, when appropriate.
  • Undertakes any other reasonable tasks requested by the Executive Director, Diligence, to ensure the smooth running of diligence projects.
  • Take responsibility for personal learning and development in order to reach, and maintain, the required level of skills, knowledge and experience to perform the role.










Key Competencies

.

Main requirements

  • Successful completion of academic degree or PhD in Pharmaceutical Science/Technology, or a graduate from a University of Applied Sciences with a focus on management or natural sciences, or similar formal education and training.
  • Significant experience in the pharmaceutical industry, with extensive knowledge of clinical research and pharmaceutical development and the interactions between R&D, commercial and business development organisations.
  • Excellent experience with MS-Office with particular emphasis on Word and PowerPoint.
  • Good understanding of project management principles and project management tools, skills and practices.
  • Ability to work both independently and within a cross-functional team to achieve results.
  • Excellent communication skills demonstrating ability in organising and taking ownership of progressing complex processes.
  • Demonstrates and encourages ownership and responsibility, drive and motivation.  Has a “can do” attitude and is committed to delivering results and strive for continuous improvement.
  • International travel as and when required.

We Offer

This role will offer you the opportunity for personal development and will strengthen and enhance your scientific knowledge and understanding.

Contact Information

Name: Vanessa McHaffie
Email: mr.hr@mundipharma-rd.eu
Telephone: 01223 424900
Adress: HR Department
Mundipharma Research Limited
Cambridge Science Park
Milton Road
Cambridge
CB4 0GW

print page