Global Program Clinical Head - Neuroscience Early Pipeline

A job vacancy for a Global Program Clinical Head Neuroscience Early Pipeline has arisen at a leading global pharmaceutical company specialising in development of biological therapies.

Job Responsibilities:

• Clinical assessments of internal (NIBR) as external (BD&L) early clinical programs across indications in assigned TA.
• Supporting decision milestones, regulatory requirements and market access for those early compounds in collaboration with relevant other functions like DRA, New products, market access and others.
• Contributing to the development and execution of the disease area strategy and the biomarker strategy, including:
• The development of TA strategies including biomarker if appropriate.
• Serving as the Clinical Development Representative on NIBR clinical/project teams to drive transition of pre-PoC (Proof of Concept) projects to Development Decision Point (DDP).
• Supporting Business Development & Licensing (BD&L) activities and is member of BD&L Search and evaluation team.
• Leading the development of the clinical strategy for GDD, pre-DDP.
• Developing a high level endorsed Integrated Development Plan (IDP) in line with the Target Product Profile (TPP) which is designed for successful global regulatory approval/market access for one or multiple treatment indications and/or multiple programs.
• Together with Patient Safety and if relevant Translational Medicine, ensures evaluation of drug safety profile and signal detection.
• Leading interactions with external stakeholders (e.g. regulatory authorities, key opinion leaders, data monitoring committees, advisory boards, patient advocacy groups), internal stakeholders (e.g. Research, Translational Medicine, Global Medical Affairs (GMA), Marketing, Health Economics & Outcomes Research), and internal decision boards.
• Supporting TAH with leading the peer-review of IDPs, CTPs, and other clinical documents across various indications and programs; and with driving excellence across clinical trial strategy, design, and execution.
• Ensuring career development of program reports through active participation in the performance management, talent review, and succession planning processes. Provides on-boarding, coaching, and/or mentoring support; develops and fosters Clinical Development culture.
• Responsible for medical/scientific training of relevant stakeholders on the disease area and compound/molecule. May serve as speaker for franchise
• medical/scientific training.
• Leading or serving on global process improvement work streams, act as Subject Matter Experts for standard operating procedures or trainings, and/or contributes to other cross-functional or Clinical Development line function initiatives.

Skills and Requirements:

• ≥ 5 years people management experience required; this may include management
  in a matrix environment.
• ≥6 years (MD or equivalent)/ ≥ 10 years (PhD or PharmD) of involvement in clinical
  research or drug development in an industry environment spanning clinical activities
  in Phases I through III/IV, including submission dossiers.
• Specialisation in a subspecialty may be needed.
• Advanced clinical training/knowledge in medical/scientific area aligned with TA
  Medical Board certification preferred.
• Advanced knowledge in medical/scientific area (e.g., oncology, haematology,
  endocrinology) required Fluent oral and written English development in an academic
  or industry environment spanning clinical activities in Phases I through III (some
  industry experience preferred).
• Advanced knowledge of assigned therapeutic area required, with the capability to
  innovate in clinical development study designs that provide relevant evidence to
  decision-makers, and to interpret, discuss and present clinical trial or section
  program level data.
• Thorough knowledge of Good Clinical Practice, clinical trial design, statistics, and
  regulatory/clinical development process.
• Experience with submissions and health authorities required.
• Experience with BD&L activities including clinical stage compounds.
• MD or equivalent required.
• Demonstrated ability to establish strong scientific partnership with key stakeholders.
• Demonstrated leadership and management skills with a documented track record.
  of delivering high quality projects/submissions/trials in a global/matrix environment
  (including remote) in pharmaceutical or biotech industry.
• Considerable organisational awareness including significant experience working
  cross-functionally and in global teams.
• Demonstrable multitasking, project management, and execution skills.
• Good interpersonal skills, including communication, presentation, persuasion, and influence.
• Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
• Proficiency with computer skills, such as MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Terence Au 0203 861 8605 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

#LI-TA2

#MedicalAffairs