Oncology Early Development Center Network Lead in Munich, ND at Daiichi Sankyo

Job Description

Join a Legacy of Innovation 110 Years and Counting!

Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. Under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.

Summary

The Oncology Early Development Center (OEDC) Network Lead is 100% dedicated to OEDC and will provide support both externally to the sites and internally to OEDC leadership, including the OEDC Chief of Staff (COS) in establishing and facilitating an effective world class DS FIH Site Network. This transformative network will provide better opportunities to access some of the top global sites and principal investigators while also establishing long term relationships necessary for transforming Daiichi Sankyo (DS) early development to be regarded around the world as one of the most innovative, trustworthy, and science-driven organizations in the industry. This role will help OEDC to accomplish its mission to create an innovative and robust global network, to execute oncology early development scientific and First in Human strategies efficiently. The Network Lead plays a central role in the site selection process, site and functional teams' engagements, while also managing DS FIH Site Network meetings, alignment, and participation of KEE in OEDC lecture series. This position is globally focused to ensure network sites are representative of DS global vision. The Network Lead will assist to drive strategy, coordinate, and facilitate key global oncology early development studies, functional lines including, global regulatory operations, biostatics, data management, clinical science and clinical operations. The Network Lead will have direct accountability for administrative deliverables, will interact regularly with OEDC leadership, and will play a role to integrate DS FIH studies globally. The added role Network Lead is accountable to ensuring that the DS FIH Site Network is prepared to meet any new or proposed oncology early development requirements and evaluate the sites' compliance with network objectives. This position acts as a "change agent" within DS to ensure an effective and efficient strategic change of prioritization of network sites before recommendation of sites outside of the DS FIH Site Network. This position interfaces with the OEDC Scientific and Infrastructure Committees as well as leads the KEE committee.

Responsibilities:

The Network Lead is an enterprise-level support for the OEDC and is responsible for oversight of all network activities, including:

• Assessing potential new network sites for appropriateness to join the DS FIH Site Network.
• Maintaining communications among the PIs, Sites, KEEs in the DS FIH Site Network and the Center.
• Managing network relationships between OEDC and the KEEs and sites.
• Traveling to sites multiple times per year for relationship building amongst network sites.
• Responsible for managing internal and external conferences/symposiums to network with OEDC PIs and site personnel, holding (for example) quarterly and annual meetings with the DS FIH Site Network to ensure agile study start-up/MSAs in place, enrollment target needs, etc.
• Responsible for executing and managing the KEE tumor boards, lecture series, topic and portfolio KEE meetings.
• Working with the OEDC head to evaluate sites and recommend course corrections.
• Being a change management agent between the DS functional areas and the sites.
• Overseeing coordination and escalation of incidents between teams, regions, and sites.
• The Network Lead will work cross-functionally to aid in proposing or executing studies at a network site.
• The Network Lead will not manage any individual study or trial. The Network Lead: Focuses on managing the entire DS FIH Site Network and the execution of the DS portfolio of studies in the sites. Responsible for coordination across functional areas addressing time, cost and quality of deliverables.
• Works with the OEDC Head to select sites that are most appropriate for individual studies. Works with functional areas to open and execute the studies at member sites.
• Oversight of functional area interactions with sites.
• Works across functional areas to create a study-related site/KEE meeting where sites will provide direct feedback in the concept/protocol development stage to aid in refining study design.
• The Network Lead is responsible for reviewing and monitoring site performance across all early phase FIH studies in the portfolio at the sites. Such measurements will be reviewed both per site running multiple studies, and per study at multiple sites. These metrics include time to open, first patient on study, other KPIs and KQIs.
• Works with OEDC Program Lead to design and update of OEDC Network Dashboard for content management.
• Identifies trends, issues and risks across the network sites.
• Utilizes site performance and quality data to optimize prioritization of oversight.
• The Network Lead reports to the Head of the OEDC, and conducts all other duties as assigned by OEDC leadership team, including OEDC Program Lead
• Assists OEDC Program Lead in drafting OEDC, G-PAD, and other DS leadership deliverables.
• Responsible for providing updates from DS FIH Site Network and KEEs to OEDC newsletter.

Qualifications: Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
Education Qualifications: (from an accredited college or university)

• Bachelor's Degree required.
• PharmD preferred.
• PhD preferred.
• MD preferred Experience Qualifications
• 4 or More Years Relevant global, multinational experience is required required.
• Experience in assessing potential new FIH sites and in FIH site clinical operations methods required.
• Experience in site selection for network membership preferred.
• Experience considered relevant includes clinical or basic research in a pharmaceutical company, a medical device/Diagnostic company, Academic Research Organization (ARO) or Contract Research Organization (CRO). preferred
• Early Oncology Development experience preferred.
• Time spent directly in a medical environment preferred.
• Familiarity to a Japan-based organization preferred.

Travel Ability: to travel up to 30% In-house office position that may require occasional travel (domestic and 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.