At Daiichi Sankyo, we are united by a single purpose, to improve lives around the world through innovative medicines. With a legacy of innovation since 1899, a presence in more than 30 countries, and more than 19,000 employees, we are advancing breakthrough therapies in oncology, cardiovascular disease, rare diseases, and immune disorders. Guided by our 2030 vision to "be an innovative global healthcare company contributing to the sustainable development of society", we are shaping a healthier, more hopeful future for patients, their families, and society.
This position is a Clinical Science lead position and will lead a group of clinical scientists organized around one or more clinical stage assets (including those at the pre-IND stage) within the Global Clinical Science function. This position may be at the executive director level or senior director level, depending on the scope and size of the asset program. This Clinical Science (CS) lead will be responsible for leading and managing one or more clinical scientists, oversee a program of clinical trials from the clinical science perspective, and ensure the writing of high quality clinical trial protocols, review of clinical data and Clinical Study Reports (CSRs)/outputs throughout the project life cycle. The CS lead will also contribute to the program study strategy, planning, execution and reporting outputs. CS lead responsibilities include overseeing the CS direct reports who will be responsible for the writing of protocols / amendments and associated documents (writing of ICF, DM charter, response assessment charter, etc), clinical data review excellence with a focus on patient safety and data integrity, site scientific engagement, and HA responses. Interactions with the internal clinical study physicians and physician scientists as well as external investigators is expected. Depending upon team composition and scope of program, the CS lead may also be responsible for study level clinical sciences responsibilities, as well as clinical and safety monitoring under direct guidance of a physician (Global Clinical Leader or Physician Scientist). The clinical science lead will also participate in the creation and management of new clinical science group from existing pool of clinical scientists, formulate a structure and a resourcing plan, and develop capabilities to serve the needs of the enterprise based on a vision for the function. As a member of the Global Project Team (GPT), the incumbent closely collaborates with the Global Clinical Lead (GCL), the Global Team Leader (GTL), and other members of the GPT and key stakeholders and leaders across the Global Daiichi Sankyo R&D organization to achieve desired business results (short-term, mid-term, long-term).
Accountable for developing the Global (Oncology) Clinical Science Strategy and delivery of clinical studies for one or several oncology assets:
Create a performance-based team culture with clear accountability and a sense of urgency for achieving results. Lead (recruit, hire, coach, develop, motivate, manage and monitor performance) managers and/or professionals in department specific knowledge, process and procedures. Sets clear job expectations, provides regular feedback, conducts timely Performance Plan reviews, identifies performance challenges, creates action plans and monitor the effectiveness of those action plans. Complete Career Planning and competency assessment to ensure professional development of department members. Ensure that CS are maintaining up to date knowledge of all-important advances within oncology through scientific literature, attendance at critical meetings and relationships with Key External Experts (KEEs). Contributes to clinical/scientific training of relevant DS stakeholders on the disease area and compound/Drug. May serve as speaker for program/ franchise medical/scientific training Guide the Clinical Science staff in the creation of the development strategy ensuring the highest scientific/medical standards in accordance with ethical and regulatory requirements across regions. Interact with clinical investigators, academic organizations, co-development partners, and strategic outsourcing. Contribute to Clinical (oncology) Development initiatives, global education and process development projects, as required.
May serve on or lead global initiatives (e.g., process improvement, Protocol review, training, SOP development, other Clinical (oncology) Development line function initiatives) and represent the function on various leadership teams and committees.
Master's Degree or equivalent preferred PharmD or equivalent preferred PharmD or equivalent preferred Postgraduate training in oncology or related specialty, or equivalent preferred
7 or More Years relevant clinical oncology experience preferred
Ability to travel up to 30% of the time. In-house office position that may require travel (global).
Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.
USD$234,450.00 - USD$390,750.00
Daiichi Sankyo is an innovative global healthcare company contributing to the sustainable development of society that discovers, develops, and delivers new standards of care to enrich the quality of life around the world. With more than 120 years of experience, Daiichi Sankyo leverages its world-class science and technology to create new modalities and innovative medicines for people with cancer, cardiovascular, and other diseases with high unmet medical need.
For all other inquiries about Daiichi Sankyo such as products or careers, please visit our website www.daiichisankyo.com.
