Senior Medical Director, Clinical Science

Kyowa Kirin Co.; Princeton (AL); Hybrid; USD 302,000 - 335,000; Full time

Benefits offered by this job

401K with company match

Annual Bonus Program

Generous PTO and holidays

Healthcare Benefits

HSA & FSA

Job summary

Kyowa Kirin is seeking a Senior Medical Director, Clinical Science, to lead clinical strategy and regulatory documentation for development programs. You will guide internal teams from program milestones to regulatory submissions, while maintaining KOL relationships and scientific leadership across disease areas.

The role requires 10+ years in pharma with 5+ in clinical development, MD/PhD or equivalent, and strong endocrinology background.

Qualifications

• MD, MD/PhD, or clinical PhD with R&D experience.
• 10+ years pharma industry experience; 5+ years in clinical development.
• Experience with external partners and KOLs.
• Endocrinology expertise preferred.
• Strong leadership and strategic thinking in drug development.

Responsibilities

• Serve as SME for internal project teams and guide clinical perspective.
• Prepare clinical sections of regulatory submissions and engage with authorities.
• Help formulate clinical development strategies and plans.
• Lead protocol development with disease-area expertise and ensure feasibility.
• Contribute to Target Product Profile and safety analysis.
• Oversee external medical monitors and ensure trial integrity.

Skills

Leadership in clinical teams

Regulatory submissions knowledge

Written and oral communication

Cross-functional collaboration

KOL relationship management

Education

MD/PhD or MD with clinical science

Tools

MS Office Suite

Job description

Kyowa Kirin is a global specialty pharmaceutical company backed by more than 70 years of breakthrough life science innovation, dedicated to discovering and advancing treatments for diseases in which unmet need is greatest. Based in Japan with worldwide operations, we work across the continuum from drug discovery to commercialization, guided by our commitment to patients and their families.

Our research teams, located in California and around the world, are focused on developing the next generation of antibody, cell, and gene therapies, with particular emphasis on bone and mineral disorders, hemato-oncology, and rare diseases. We accelerate development through collaborations with industry, academia, patients, and healthcare providers, and since 2018 we have introduced four new therapies serving patients with progressive illnesses often in need of new therapeutic alternatives.

Our culture is grounded in our values: Commitment to Life, Integrity, Innovation, and Teamwork/Wa, and brought to life through the Kabegoe Principles, which define the behaviors and actions that guide how we work together to deliver meaningful impact for patients.

We’re proud of the progress we’ve made and mindful of the countless individuals still waiting for their own breakthroughs. A commitment to making people smile unites our efforts. Learn more at www.kkna.kyowakirin.com.

Summary:

The Senior Medical Director, Clinical Science is a vital position in our growing global organization. As part of the Development Strategy & Science group, this position 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. In this role, the position will dive deeply into the underlying science, as a subject matter expert in the field. She/he will play an active role in the creation of regulatory documents (e.g., BB, IND), study protocols, and clinical development plans. The position will be responsible for establishing and maintaining KOL relationships.

Essential Functions:

• Serve as subject matter expert for internal project teams, providing guidance from clinical perspective.
• Create written material for clinical sections of key regulatory submissions; interface with regulatory authorities in each country to provide support for regulatory submissions and ensure compliance with local regulatory requirements and standards throughout the course of clinical trials.
• Contribute to the formulation of clinical development strategies, in collaboration with related functions, and create clinical development plans, accordingly.
• Actively contribute to the formulation of clinical trial protocols with sufficient feasibility and high probability of success based on expertise in the disease area.
• 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. SAE assessment, as needed.
• Perform close oversight of work performed by external medical monitors involved in group’s clinical studies.
• Maintain knowledge of scientific developments in field and activities of competitors.
• Create and maintain good relationships with KOLs and clinical investigators; identify physicians with potential to serve as strong investigators for clinical studies.
• Attend relevant scientific meetings to strengthen competency in field and to gain awareness of research activities underway.
• Lead and author the publications and meeting presentations of clinical trials and review articles in cooperation with Medical Writing.
• Support business development, as needed, in due diligence efforts of new in-licensing opportunities (or other topics).
• Perform other duties, as required.

Requirements:

Education

MD, combined MD/PhD, or relevant clinical or biomedical Ph.D. A degree in science, pharmacy, nursing, or MSc with significant, applicable R&D experience may also be considered.

Experience

• A minimum of 10 years of pharmaceutical industry experience with a minimum of five (5) years in clinical development; significant comparable experience outside of pharmaceutical industry may be considered.
• Significant experience and ability to work effectively with external partners, including physicians and vendors.
• Advanced specialty training in Endocrinology greatly preferred.

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 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 (strategically and tactically) and simultaneously consider scientific, medical, and business aspects of projects.

Working Location

Expect average of 2 days per week in office (or eight days/month) with details of schedule being agreed jointly with manager based on business needs.

Working Conditions

Requires up to 10% domestic and international travel

The anticipated salary for this position will be $302,000 to $335,000. The actual salary offered for this role at commencement of employment may vary based on several factors including but not limited to relevant experience, skill set, qualifications, education (including applicable licenses and certifications, job-based knowledge, location, and other business and organizational needs.

The listed salary is just one component of the overall compensation package. At Kyowa Kirin North America we provide a comprehensive range of benefits including:

• 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

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.

KKNA and all of its employees have an obligation to act in accordance with the law and with integrity in all our operations and interactions

It is the policy of Kyowa Kirin North America, Inc. to provide equal employment opportunity to all qualified persons without regard to race, religion, creed, color, pregnancy, sex, age, national origin, disability, genetic trait or predisposition, veteran status, marital status, sexual orientation or affection preference or citizenship status or any other category protected by law.

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Recruitment & Staffing Agencies

Kyowa Kirin does not accept agency resumes unless contacted directly by internal Kyowa Kirin Talent Acquisition. Please do not forward resumes to Kyowa Kirin employees or any other company location; Kyowa Kirin is not responsible for any fees related to unsolicited resumes.

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