Development Scientific Director, Oncology

Job summary and key strategic intent

The Development Scientific Director (DSD) manages the clinical development of drug candidates. The DSD will have a solid understanding of all phases of early pharmaceutical drug product development, including clinical trial design, management, IND and CTA submissions, medical monitoring, GCP principles, and will have experience in collaboration with Clinical Science, Clinical Operations, Research and Clinical Pharmacology, Regulatory Affairs and other key stakeholders.

The role requires strong subject matter expertise and/or ability to independently research the area of study, and is a well-organized, strategic focused, resourceful individual with excellent emotional intelligence, self-motivation and ability to operate at a “hands on” level and leads trial conduct with ease and authenticity.

• Serve as the clinical and/or medical lead on one or more early preclinical/clinical molecules within the Sanofi pipeline from and able to apply clinical relevance and translation from preclinical data as projects move from Phase I through proof of concept.

• Serve as the clinical and/or medical lead on individual clinical trials in partnership with Clinical Science, Clinical Operations, Drug Safety, Regulatory, Clinical QA and other key stakeholders

• Contribute to strategic and scientific discussions on related projects and technologies within the Clinical Development team.

Key individual duties, responsibilities

• Contribute to clinical development planning and clinical strategy

• Work with academic leaders/advisers to develop clinical strategy

• Provides clinical leadership and medical strategic input for all clinical deliverables in the assigned project or section of a clinical program if applicable

• Design clinical studies and develop protocols to execute clinical development strategies

• Clinical deliverables may include clinical sections of individual protocols, clinical data review, program specific standards, clinical components of regulatory documents/registration dossiers, and publications 

• Review all key documentation such as IND/CTA, health authority communications and other documents (DUSR, INDAR, DRMP, RMP, etc), protocols and amendments

• Leads development of clinical sections of trial and program level regulatory documents (e.g., Investigator’s Brochures, briefing books, safety updates, submission dossiers, and responses to Health Authorities) and supports all other Regulatory activities and NDA related questions

• Work cooperatively with Clinical Operations and designated CROs to execute the programs (e.g. lead study start up and database lock, performs data and coding reviews; draft/present clinical slides for Investigators Meeting, Advisory Boards and therapeutic/monitor training; review draft CRFs, etc.)

• Drives execution of the section of the clinical program in partnership with other line functions (regulatory, clin ops)

• May act as study medical monitor ensuring overall safety in collaboration with the Global Safety Officer of the molecule, and supports overall program safety reporting (e.g., Periodic Safety Update Reports (PSURs), Drug Safety Update Reports (DSURs), and other safety related documents) in collaboration with Patient Safety

• Consistently complies with, and ensures the compliance from direct reports, of all governing laws, regulations, Sanofi Standard Operating Procedures (SOPs) and other guidelines

• Keeps abreast of the highest standards and levels of scientific and clinical knowledge in relevant therapeutic and disease area(s).

• Review all data generated across the program to update strategy and risk assessment

• Regular review of competitive intelligence to update risk, differentiation and valuation of program

• Collaborates with Sanofi and external partners, regulators, and diverse internal stakeholders and collaborators

• Other duties commensurate with position as assigned

• Ability to travel required

Skills, competencies required

• Experience with pharmaceutical product development collectively through clinical science or clinical trial conduct

• Expertise in clinical development and methodology of clinical studies and GCP principles

• Ability to adapt and learn quickly in new areas of research, clinical development, and have resourcefulness to independently gather relevant information

• Independent creative thinking related to overcoming hurdles and problems.

• Excellent communication skills (verbal and written) for interactions across functional areas and for interactions with investigators, key regulatory agencies

• Demonstrated cap