Director Clinical Development Sanofi Swiftwater

Job Description
The Primary Responsibilities For This Position Are

Medical monitoring of clinical trials to maintain patient safety

Compliance with ICH-GCP guidelines

Communication with principal investigators and study site coordinators in order to address any scientific and medically-related inquiries

Serve as medical expert on call for site audits and inspections (will delegate as appropriate to regional colleagues)

Review and reporting of all serious and non-serious adverse events

Current with SOP training and maintains up-to-date training records

Clinical trial management from research to licensing, including ownership and strategic direction of Clinical Development Plans (CDP)

and the subsets of the Common Technical Document (CTD)

Contribution to the strategic vision of the project and support the project team as a member of Clinical Development

Liaise with Senior Director/ Clinical Franchise Leader to ensure CDP is aligned with Franchise objectives

Ensure clear, timely and consistent strategy definition across the clinical trials reflected in the CDP

Organize the CDP to encompass plans for three to five years

Lead the interpretation and critical evaluation of study results

Contribute to the generation and submission of documentation to Regulatory and Health Authorities, including Clinical Study Reports and INDs

Ensure CDPs are properly reviewed and approved by internal committees prior to submission

Adherence to both adherence to internal procedures and regulatory/ industry standards

Interact with global Sanofi Pasteur employees for future US trials and compliance

Oversee the operational aspects of the clinical trials and interact with internal team members and external clients

Ensure the timelines and quality requirements of trials are clearly communicated and followed

Be a contributing member of the Clinical Development organization

Timely and accurate accomplishment of key project milestones including the design of the clinical development strategy, licensure submissions,

and integration of clinical data for milestone decision processes

Participate actively in process improvement and other initiatives

Ensure that the Clinical Development Plans are reviewed with the document review committee to ultimately present documentation to the FDA

Interact with the Program Managers, other Franchise Leaders and other internal members in a positive and collaborative manner

Work as a project team member

Multi-company project teams to incorporate multiple antigens into a single vaccine

Coordinate multi-departmental input for writing and capturing data

Coordinate and interact with corporate committees for budgeting for clinical trials and presentation of CDPs

Periodically review all safety data from all ongoing clinical trials as a member of a Safety Management Team

Preparation of presentation materials including study results internally to senior management and externally to investigators,

outside partners, regulatory agencies and public health agencies

As Appropriate, Serve As Ambassador For Sanofi Pasteur

Representing the Company in conferences (international and domestic)

Author publications

Establish, develop and maintain a network of Key Opinion Leaders (KOLs) and leading scientists in the field



Performance Expectations:

Performance Expectations In The First Year Include

Assimilate into the internal Clinical R&D team on a global scale - this includes working well with international Clinical Development

and Public Policy teammates as well as internal Project Leaders

Ensure that project timeline and quality milestones are met

Contribute to the strategic vision of assigned vaccines

If required, an adjustment to the industry environment and setting

Specific Skills & Experience

Experience in Infectious Diseases, vaccines preferred; experience in Immunology acceptable

Clinical trial experience preferred

Experience in conducting clinical trials preferred; working knowledge of ICH/ GCP guidelines and IRBs preferred

Bench experience a plus

EIS training very advantageous

Personal Characteristics

Demonstrated organizational skills

Ability to network and communicate clearly

Personal drive to surpass timelines on projects

Ability to multitask and re-prioritize

Politically astute

Ability to work well under pressure

Positive and welcoming personality

Intuitive drive for novel science