Early Clinical Development Project Lead ( M/F)

Description de l'offre

As core member of a global project team, the main mission of this position is to build strategy for early clinical development plans for Antibody Drug Conjugates (ADCs) projects and to lead the establishment and execution of the early development plan.

This position in Sanofi R&D Organization is reporting to the Global Project Head for Antibody Drug Conjugates.

Main Responsibilities

·  Define strategy and establish or adapt clinical development plans for early ADC projects including discussions with advisors and regulatory authorities and contingency planning.
·  Present and discuss development strategy with key internal stakeholders, external investigators and advisory boards, and regulatory authorities, as appropriate
·  Lead the clinical team for early clinical development of one or more ADC projects to establish the development strategy and execute the development plan., interacting with key internal stakeholders in Translational Medicine , in Clinical Operations as Biostatistics and Medical Operations, in Regulatory and Pharmacovigilance
·  Author protocol extended synopses, IB, clinical sections of IND/IMPD fillings, annual reports, development risk management plans.
·  Lead and author clinical summaries and overview for regulatory submissions.
·  Author clinical abstracts, presentations for conferences, and manuscripts, when appropriate

This role is also a core member of the global project team and can evolve to a role of global project leader.

In that function, the individual should be able to:

·  Ensure an effective, well-functioning team with preclinical research, translational medicine and biomarkers, pharmacokinetics and toxicology, chemistry and manufacturing, and project management.
·  Regularly review emerging preclinical, clinical data and adapt project strategy as appropriate
·  Oversee project planning to ensure optimal use of resources and timely implementation of the project plan.

Beyond responsibilities on the project team, the individual should also:

·  Serve as an Clinical expert reviewer on the Oncology Protocol Review Committee
·  Contribute to continuous improvement initiatives, effective team building and communication across the Oncology Clinical Development team and the broader organization.

Profile

·  MD degree or equivalent
·  Oncology fellowship or significant experience in Oncology (5+ years)
·  Expertise in medicine, oncology and pharmaceutical medicine based on industry experience (3+ years) or academic clinical research experience (3+ years)
·  Good understanding of the drug development process and experience with US and EU regulatory submissions
·  Strong demonstrated leadership skills and clinical expertise in the field for effective international collaboration with external and internal stakeholders.
·  Demonstrated ability to effectively work in a multi-disciplinary and multi-cultural environment to achieve efficiently project milestones and objectives
·  Lead by influence, with ability to develop and maintain excellent interpersonal relationships
·  Demonstrated ability to interact productively with external stakeholders as KOL& investigators and with Regulatory Agencies
·  Excellent communication & presentations skills
·  Understanding of and willingness to meet quality, compliance and applicable regulatory standards

At Sanofi diversity and inclusion are foundational to how we operate and are embedded in our values. We respect the diversity of our people, their backgrounds and experiences. We recognize that to benefit from the wealth that diversity brings, we must lead with inclusion and have a workplace where differences can thrive and be leveraged to empower the lives of patients!

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.