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 .
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:
EducationMD, 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
- SkillsStrong 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 AwardsThe 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. When you apply to a job on this site, the personal data contained in your application will be collected and stored by Kyowa Kirin, Inc. ("Controller"), which is located at 510 Carnegie Center Dr. Princeton, NJ 08540 USA and can be contacted by emailing kkus.talentacquisition.8h@kyowakirin.com. Controller's data protection officer can be contacted at usprivacyoffice@kyowakirin.com. Your personal data will be processed for the purposes of managing Controller's recruitment related activities, which include setting up and conducting interviews and tests for applicants, evaluating and assessing the results thereto, and as is otherwise needed in the recruitment and hiring processes. Such processing is legally permissible under Art. 6(1)(f) of General Data Protection Regulation (EU) 2016/679 ("GDPR") as necessary for the purposes of the legitimate interests pursued by the Controller, which are the solicitation, evaluation, and selection of applicants for employment. Your personal data will be shared with Greenhouse Software, Inc., a cloud services provider located in the United States of America and engaged by Controller to help manage its recruitment and hiring process on Controller's behalf. Accordingly, if you are located outside of the United States, your personal data will be transferred to the United States once you submit it through this site. The transfer will be made using appropriate additional safeguards under the standard contractual clauses approved by regulators for transfers of personal data outside the European Union. Your personal data will be retained by Controller as long as Controller determines it is necessary to evaluate your application for employment. Under the GDPR, if you are located in the European Union, you have the right to request access to your personal data, to request that your personal data be rectified or erased, and to request that processing of your personal data be restricted. You also have the right to data portability, and to lodge a complaint with an EU supervisory authority. If you have any questions about our use of your data, you may contact us by email at usprivacyoffice@kyowakirin.com. 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.#LI-TT1 #Hybrid #Princeton
