Clinical Trial Diversity Head in Remote at Daiichi Sankyo

Date Posted: 7/17/2024

Job Snapshot

  • Employee Type:
    Full-Time
  • Experience:
    Not Specified
  • Date Posted:
    7/17/2024
  • Job ID:
    R3364
  • Location
    Basking Ridge,NJ

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 16,000 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 Head of Clinical Trial (CT) Diversity sits within Global Oncology Clinical Development, an organization dedicated to the effective strategy, design, execution, and interpretation of Oncology clinical trials. We strive to ensure that clinical trials are representative of the diverse populations they aim to serve. •Leads cross functional development and implementation of strategies to enhance diversity and inclusion in our clinical trials •Accountable for the process by which diversity plans are established in adherence with Good Clinical Practices (GCP), Standard Operating Procedures (SOPs), Health Authority (HA) Regulations and International Conference on Harmonization (ICH) guidelines •Surveys the regulatory landscape related to trial diversity along with the RA and updates our trial diversity strategy and tactics as appropriate •Leads the data acquisition that study teams will utilize to develop study specific clinical trial diversity plans •Leads the strategy of country and site selection across assets from the perspective of accomplishing the goals of enhancing diversity in our clinical trials •Accountable for developing a strategy to leverage patient advocacy groups and related patient organizations in support of achievement of our organizational trial diversity objectives, along with the Patient Advocacy Group •Accountable for developing trial diversity metrics and measuring success of our trial diversity program against these metrics •Matrix management responsibilities across the internal and external network •Supports study teams by implementing the DS framework, guidance and further instruction around diversity and inclusion in our clinical trials

Responsibilities

- Strategic Leadership

- Develop and implement a comprehensive cross-functional strategy and process to enhance diversity and inclusion in all phases of clinical trials
- Leads a matrix team of cross functional partners, including but not limited to: Global Clinical Operations, Global Regulatory Affairs, Biostatistics and Data Management, Epidemiology, Patient Advocacy, and Global Oncology Medical Affairs to integrate diversity considerations into study planning and execution
- Partner with Disease Area Strategy Team (DAST) leaders to ensure diversity and inclusion toolkits are based upon DS needs as well as include real-time feedback, lessons learned, and represent enterprise-wide best practices

- Stakeholder Engagement

- Build and maintain relationships with community organizations, including advocacy groups and healthcare professionals to foster collaboration and promote diverse patient recruitment
- Work closely with patient advocacy team and groups (internally and externally) to understand and address barriers to diverse participation in DS clinical trials

- Clinical Trial Design

- Provide input to Therapeutic area leadership as well as Global Clinical leads in the establishment of a Clinical Trial Diversity template to be followed by study teams when designing and implementing clinical trials that are inclusive and representative of diverse patient populations
- Collaborate with Oncology Clinical Development Global Clinical Leads to ensure appropriate consideration of diversity is included in study protocols
- Collaborate with Global Clinical Operations leadership to ensure recruitment strategies include considerations for diversity and the needs of our oncology portfolio

- Education and Training

- Develop and deliver training programs for internal teams (Clinical Development, Clinical Operations, etc.), investigators, and site staff to enhance awareness and understanding of DS diversity and inclusion practices

- Data Analysis and Reporting:

- Collaborate with the Biostatistics and Data Management (BDM) teams to develop metrics and Key Performance Indicators (KPIs) to analyze and report on diversity metrics in clinical trials
- Monitor data and regularly communicate findings to senior leadership to make recommendations for process improvements

- Compliance

- Partner with Global Regulatory Affairs to ensure current regulatory requirements are met with regards to diversity and inclusion in clinical trials
- Stay abreast of industry trends and changes in regulations related to clinical research diversity and inclusion

- Health Authority Interactions

- Point of contact / subject matter expert (SME) for inspectors and/or auditors with regards to diversity and inclusion in our clinical studies
- Contributes to HA response / leads CAPA activities related to diversity and inclusion

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 Bachelor's Degree in a relevant scientific discipline with relevant work experience required and
- PhD preferred or
- PharmD preferred

Experience Qualifications

- 7 or More Years •7+ years of pharmaceutical industry experience in trial diversity and patient access and/or clinical operations project management (required) required
- •Demonstrated success in working with cross functional teams in a global matrix; 2+ years of managing or supporting global cross-functional process initiatives and teams preferred
- •Experience interpreting quantitative data and analyzing metrics preferred
- Experience interpreting quantitative data and analyzing metrics preferred

Travel

Ability to travel up to 10%. Travel might be required


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.