Job Summary

Oversees early-stage hematology trials, such as global clinical development program for multiple product candidates with one or more indications; Interacts with our Discovery and Research programs for development of early clinical studies. Provides senior level clinical representation at meetings with health authorities; Leads the creation of developmental and regulatory strategy; Accountable for performance of CROs; Routine interactions with senior management of CRO, as needed; Accountable for clinical development plans, protocol profiles and sections of key submission documents; Represents Clinical Development as team leader or as supervisor of team leaders; Accountable for Clinical Development input into commercial strategy including Translational Medicine and biomarker strategy; Thought partner in driving Business Development decisions in collaboration with External Scientific Affairs dept.

Job Description

Responsibilities

• Clinical Monitoring Planning: Oversees and coordinates Sponsor oversight of CRO clinical Monitoring activities, including plan for internal communication and issue escalation with Clinical Study Lead (CSL)
• Clinical Surveillance: Documents ongoing Clinical Monitoring review of data for safety (with Clinical Safety Pharmacovigilance) and quality at project level; Ensures global consistency of clinical Monitoring activities; Defines or contributes to department level surveillance activities across projects
• Study strategy: Interacts with leaders of each function to develop study strategy; Approves project or TA-level TM and biomarker strategy in collaboration with Translational Medicine and Clinical Pharmacology; Attends regulatory agency meetings and leads clinical strategy discussions
• Study planning and execution: Develops prospective contingency plans for management of key risks across a large project or a portfolio of projects or across the Therapeutic Area; Clearly defines priorities and high-level execution plans across projects within and outside of Daiichi Sankyo; Supports effective communication and decision-making process cross-functionally and cross-regionally at department level
• Study Outputs: Has strong understanding of statistics and study design principles applicable to primary and efficacy and safety endpoints in registrational trials to critically assess study conclusions and new study designs for early stage.
• External collaboration: Ensure continuous, effective alignment within / between CRO and vendors; For large, multiple indication project in late development, develops and leads Ad-Board with top tier KEEs for project level strategic advice; Consults with KEEs for advice on complex development or safety issues; Maintains and leads external collaborations and advisory panels at department level
• People Management: Assign staff with appropriate training and experience or arrange requisite support to lead large study teams, coordinate complex studies, lead projects, and/or ensure proper medical oversight; Monitor and manage direct report’s performance in such roles, ensuring that there is proper understanding of task complexity and management of key risks; Participate in department’s planning for staff and cross-functional staffing plans for the Therapeutic Area.
• Additional Non-Study related activities: Routine senior management interactions; Influential relationship with top KOLs; Committee member, in-licensing and acquisitions

Qualifications

Education Qualifications (from an accredited college or university)

• MD or MD/PhD with relevant clinical and industry experience required in clinical hematology
• Postgraduate training in TA or related specialty required

Experience Qualifications

• 7+ years’ experience required
• 4+ years managing Clinical Development group required