$150K - $200K(Ladders Estimates)
At Janssen Immunology, our vision is to restore health for the millions of patients living with immune disease. Our approach to achieving this aspirational vision is systematic and evidence-driven. We start with deep insights to unmet medical needs. We then align distinct immune pathways insights against these unmet needs. Our ultimate goal is rebalancing the immune system to achieve long-term remission. With unrivaled insights into the diseases of greatest unmet need and actionable science, we have established an industry-leading Immunology portfolio.
This position will serve as Senior Director for Clinical Immunology for Immunology marketed and investigational products in development. The successful candidate will consult and assist in direction for early phase (phase 0/I) clinical development for selected NMEs across multiple immunologic indications. They will work closely with leadership in informing, influencing and implementing strategies for all aspects of clinical development. They will design, implement and report phase II and III clinical trials and support of resulting regulatory submissions. He/she will provide the highest-level of scientific expertise through entire clinical trial process including interactions with commercial and all level of management.
Responsibilities for the Senior Director include overall program leadership:
• Designing of Clinical development program (CDP), as well as execution and reporting of trials
• Monitoring safety of clinical trials and providing scientific leadership in the area of responsibility
• Providing scientific & clinical leadership of Phase 2 and 3 clinical trial teams
• Leading the development of the Integrated Study Plans and study summaries, IND submissions, and technical reports
• Providing input to strategic decisions regarding therapeutic indications
• Overseeing the preparation of clinical portions of Immunology project INDs, IBs, CTAs, BLAs and other regulatory submissions
• Authorship of abstracts and manuscripts for publication based on clinical trial data
• Presenting data and scientific information to the organization at all levels
• Building credible relationships with opinion leaders and external alliances for partnered products when relevant
• Line management accountability for promotions, recruitment strategy and team structure
• Evaluation of business development/in-licensing opportunities and contribution to development programs
• MD or DO is required
• Board certification in a relevant therapeutic area is desired
• Experience in Immunology clinical development desired.
• A minimum of 5 years of clinical research or clinical trials experience preferably in an industry setting is strongly preferred
• Must have strong planning and communication skills to manage and proactively identify resource issues
• Experience in clinical trial design and medical monitoring is highly desired.
• Prior experience in a leadership role is a must.
• This position may require up to 10% annual travel (domestic and international).
Valid Through: 2019-10-16