Development of protocols for clinical studies.

Contribute to the development of program strategy for assigned compounds/programs including participation in the preparation of clinical development plans.

Drafting of clinical scientific documents such as IND, IND amendments, Clinical Study Reports, Investigator Brochures, Annual Reports, and other health authorities submissions.

Responsible for providing clinical input into eCRF design, SAP, and TLFs.

Monitor, review, and summarize clinical safety and efficacy data in ongoing studies.

Collaborate with study team members to conduct timely and thorough review of study data using best practices and available tools to identify and evaluate data trends.

Will lead the clinical matrix teams for assigned studies, represent clinical development on project teams and serve as liaison to project teams, CRO's and others.

Provide clinical updates on assigned studies to Sr. management, Project Teams, Joint Project Teams and/or Steering Committees (if appropriate), Clinical sub-teams, internal strategy, and governance meetings, eDMC meetings, steering committees, advocacy groups, scientific advisory boards, and publications committees.

Liaise with cross functions on training of current studies, results, meeting with lead PIs/KOLs at conferences; present as needed.

Develop relationships with appropriate consultants and external experts and utilize these relationships to obtain feedback on protocol design.

Contribute to writing and review of study abstracts, posters, oral presentations, and manuscripts for assigned studies.

Degree in scientific/life-sciences field. Pharm.D. or Ph.D. preferred.

Minimum of 4 - 6 years of experience in research with at least 3 or more years of clinical research/drug development experience are required for Director level.

Experience in Immunology field is required.

Ability to multi-task and work in a fast-paced environment.

Excellent written and oral communication skills.

Strong Analytical ability.

Ability to accommodate up to 20% travelor as business dictates.