Director, Clinical Science (non-hemato-oncology)

Kyowa Kirin North America•Princeton, NJ

18d•Hybrid

About The Position

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.

Requirements

MD (or equivalent), PharmD, PhD in life sciences or related field; applicable R&D experience may also be considered.
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
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 multinational organization
Excellent written and oral communication skills
Good project management skills; able to organize and prioritize multiple activities
Proficient in MS Office Suite, relevant software applications, using templates, and other electronic formats
Ability to think analytically (in terms of both strategy and tactics) and simultaneously consider scientific, medical, and business aspects of projects
Requires up to 15% domestic and international travel

Nice To Haves

leadership role in large, late-stage, global outcomes trials
background in Bone & Mineral or Rare Disease trials

Responsibilities

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.

Benefits

401K with company match
Annual Bonus Program (Sales Bonus for Sales Jobs)
Generous PTO and Holiday Schedule which includes Summer and Winter Shut-Downs, Sick Days and, Volunteer Days
Healthcare Benefits (Medical, Dental, Prescription Drugs and Vision)
HSA & FSA Programs
Well-Being and Work/Life Programs
Life & Disability Insurance
Concierge Services
Long Term Incentive Program (subject to job level and performance)
Pet Insurance
Tuition Assistance
Employee Referral Awards