Director, Clinical Science (non-hemato-oncology)

Kyowa Kirin is a fast-growing global specialty pharmaceutical company that applies state-of-the-art biotechnologies to discover and deliver novel medicines in four disease areas: bone and mineral; intractable hematologic; hematology oncology; and rare disease.  A Japan-based company, our goal is to translate science into smiles by delivering therapies where no adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, NJ, with offices in California, North Carolina, and Mississauga, Ontario.

Summary:

The Director, Clinical Science (non-hemato-oncology) is a vital position in our growing global organization. As part of the Clinical Science group, this person is a key member of multi-disciplinary project teams responsible for the achievement of milestones (e.g., IND, FIH, POC, EOP2, NDA) for development programs. It is expected for this role to exercise leadership in the scientific discussion in project teams from the clinical perspective, diving deeply into the science of her/his assigned program(s), and perform the role of a subject matter expert for the program(s). He/she will play an active role in the creation of regulatory documents (e.g., BB, IND), study protocols, and clinical development plans for new and/or launched products, including lifecycle management.  He/she will be responsible for establishing and maintaining KOL relationships.

Essential Functions:

•    Serve as leading voice on clinical matters as Clinical Science representative on assigned project team(s), based on firm understanding of given disease area(s) and of clinical development processes, especially in the US and Europe
•    Lead in the formulation of clinical development strategies, in collaboration with related functions, and create clinical development plans, accordingly
•    Lead in the formulation of clinical trial protocols with sufficient feasibility and high probability of success, based on significant expertise in new drug development
•    Lead in the development of written material for clinical sections of key regulatory submissions; work closely with Regulatory in the process of preparing these submissions and ensure compliance with local regulatory requirements and standards throughout the course of clinical trials.
•    Work closely with cross-functional teams, including Regulatory, Marketing, and Quality to support clinical trial design and execution, regulatory submissions, and launch-related activities.
•    Provide input from the clinical perspective to the formulation of Target Product Profiles.
•    Analyze safety and efficacy findings from clinical studies; participate in inter-disciplinary team meetings, as required
•    Support required safety evaluations for clinical studies, e.g. AE assessment, as needed.
•    Create and maintain good relationships with clinical investigators and relevant Key Opinion Leaders; identify physicians with potential to serve as strong investigators for clinical studies
•    Attend relevant scientific meetings to strengthen competency in assigned field(s) and to gain awareness of research activities underway and activities of competitors
•    Serve as an author and lead in the preparation of review articles and conference presentations, relating to assigned clinical trial(s)
•    Support business development, as needed, in due diligence efforts of new in-licensing opportunities (or other topics).
•    Foster and contribute to collaborative environment that seeks to encourage innovation, strengthen scientific understanding among team members, and enhance professional development for all.
•    Perform other duties, as required.

Requirements:

Education
MD (or equivalent), PharmD, PhD in life sciences or related field; applicable R&D experience may also be considered.

Experience
•    Minimum 10 years of relevant clinical research experience with at least 5 years in clinical development role
•    Authorship and review of clinical development plans, clinical study protocols, briefing books, IBs, SAPs, and CSRs
•    Significant experience and ability to work effectively with external partners, including physicians and vendors
•    Preferred experience: leadership role in large, late-stage, global outcomes trials; background in Bone & Mineral or Rare Disease trials

Technical Skills
•    Strong scientific background with good understanding of drug development process
•    Good leadership skills, highly motivated, great attention to detail, ability to work in complex and changing situations, excellent problem-solving skills
•    Broad level of interpersonal skills and flexibility; cultural sensitivity and ability to develop consensus within matrix structure of a mu