Clinical and Development Manager

6 days ago

Uckfield, East Sussex, United Kingdom F. Hoffmann-La Roche Gruppe Full time
Job Summary

We are seeking a highly experienced Senior/Principal Medical Director to join our Clinical Development team in the neurology franchise. The successful candidate will lead the development of the Clinical Development (CD) strategy and be responsible for developing the CD plan and ensuring effective and efficient execution for assigned molecule(s)/indication(s).

Key Responsibilities

  • Develop and operationalize the Clinical Development Plan (CDP) for assigned molecule(s)/indication(s), acting as the CDP lead and/or supervising the development of study analytics & data management plans.

  • Collaborate with internal/external partners & stakeholders, as well as multidisciplinary internal groups, including business development, research, commercial, legal, etc.

  • Participate in meetings, reviews, discussions and other interactions regarding early development/Phase I studies to provide clinical science input & guidance.

  • Lead or oversee others in development of briefing packages by providing clinical science information and input; lead or oversee others in development of responses to HA questions by providing clinical science information and input; lead or oversee others in health authority (HA) interactions.

  • Play a lead role in educating others internally and externally on relevant clinical developments as these may implicate the assigned therapeutic area's CDP strategies, plans and programs.

  • Help research and other groups to ensure consistency of scientific and late-development strategies with target label claims and corporate goals, including the ability to perform clinical assessments on relevant drug discovery projects.

  • Develop strong presence and relationships with Key Opinion Leaders (KOLs) in the field of neurodegenerative medicine.

  • Have strong experience in late-stage drug development, particularly in the US and globally.

Requirements

  • Neurologist with experience in Alzheimer's disease drug development.

  • Strong understanding of clinical development strategies and plans.

  • Excellent communication and leadership skills.

  • Ability to work in a fast-paced environment and prioritize multiple tasks.

  • Strong analytical and problem-solving skills.

About Us

F. Hoffmann-La Roche Gruppe is a leading research-focused healthcare group with a presence in over 100 countries. We are committed to delivering transformational medicines to patients and are dedicated to fostering diversity, equity and inclusion in our workplace.

We offer a range of benefits, including flexible working options, 18 weeks of maternity leave and 10 weeks of gender-independent partnership leave. Our employees also benefit from multiple services on site, such as child-care facilities, medical services, restaurants and cafeterias, as well as various employee events.

We believe in the power of diversity and inclusion and strive to identify and create opportunities that enable all people to bring their unique selves to Roche.

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