CDx Associate Director, Global Regulatory Affairs

Daiichi Sankyo; United States; Remote; USD 100,000 - 150,000; Full time

Job summary

Daiichi Sankyo is seeking a qualified regulatory strategist to oversee and contribute to the development of companion diagnostic tests and policies within oncology pharmaceuticals. This role is crucial in aligning global regulatory positions and strategies to ensure successful medical product registrations.

Qualifications

• Bachelor's Degree from an accredited college or university required.
• Master's Degree preferred; advanced degrees like Pharm D, MD, or PhD are preferred.
• 4+ years of experience in scientific and diagnostic development.

Responsibilities

• Provide strategic regulatory guidance for companion diagnostics.
• Assist with preparation of pre-submission documents for regulatory bodies.
• Keep abreast of global regulatory changes impacting device development.

Skills

Regulatory Strategy

Companion Diagnostics Development

Understanding of Diagnostic Regulations

Drug Regulatory Procedures

Cross-functional Collaboration

Education

Bachelor's Degree

Master's Degree

Advanced degree in Pharm D, MD, PHD

Job description

Join a Legacy of Innovation 125 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 125 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 18,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, 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:

Responsibility for regulatory strategy to support the development of biomarkers, companion diagnostic tests and other devices to enhance the value of our oncology pharmaceutical products.

Responsibilities:

CDx development: Provide critical strategic and tactical regulatory guidance for CDx/IVD development and CDx submission plan for each country/region, both before and after CDx testing, for less complex projects.

• At the time of implementation of a CDx study/IVDR performance evaluation study integration of an assay into clinical testing (before testing) and once data is ready for CDx submission (after testing)
• Serve as the Point of Contact (PoC) for gathering country/region specific CDx RA requirements from local RA team members (e.g. from Japan, China, Australia, Canada, Korea etc.)
• For recruitment in EU: It is critical that this person has, and continues to develop regulatory expertise on IVDR. This person will develop regulatory strategy and provide input on IVDR requirements to enable and support timely registration of both therapeutic and diagnostic products in the EU as well as UK and Switzerland.

CDx RA Strategy: Align strategy with lead CDx RA representative(s) and represent Global CDx Regulatory position and provide input and updates within internal cross-functional teams (e.g., Diagnostic Development Teams) and to external diagnostic business partners specifically:

• Use of CTA/CDx within clinical trials
• Device protocols and SAPs
• Device non-significant/significant risk determinations (both submission to CDRH in a Q-sub process and in a streamlined fashion within protocol submission to CDER via the INDs), IDEs
• Biomarker strategies towards patient selection, patient stratification, bridging between CTA/CDx assays, prospective vs retrospective analyses and collection, missing data, demographic/representativeness of samples from clinical trial and screen failures.
• Clinical trial protocol development and reviews (clinical trial protocols and medical device protocols)
• ICF reviews to ensure adequate disclosure for collection, retention, testing and retesting of samples
• Project Team Participation: Provide device-specific regulatory insight/guidance during CDx Indication Team Working Group (WG) cross-functional meetings. Serve as member of the Joint Project Team (JPT) with the Diagnostic (Dx) Partner to communicate key RA updates from the drug side, as needed. Provide RA specific inputs into CDx Risk Management plans for individual projects/indications. Assist the CDx team with the creation of contingency/backup plans for CDx submission.

Health Authority Submission Preparation: Assist with preparation of pre-submission documents and CDx related portions of therapeutic marketing applications and respond to regulatory queries/feedback from HAs. Contribute to providing timely feedback for Dx Partners to address regulatory questions from Global Health Authorizes (HAs) during review of device submissions

• In collaboration with CDx lead work with Dx partners to ensure robust development of assay, participate in HA interaction for drug-related CDx topics/questions, and attend device company HA meetings as appropriate
• In collaboration with therapeutic Regulatory leads and CDx lead develop key questions and company positions related to CDx for Health Authority interactions (for both sponsor and partner side)

CDx RA Policy and Intelligence: Keep abreast of the changing global regulatory environment for devices and share/educate CDx department on these changes

• Assessing the impacts of relevant drug and diagnostic regulations on the development and registration activities for the respective medical products

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
• Master's Degree preferred
• Advanced degree in Pharm D, MD, PHD preferred Experience Qualifications

Experience Qualifications:

• 4 or More Years Solid scientific background Understanding of scientific content and complexities and good knowledge of diagnostic development, including extensive experience of IDE submissions and approvals
• Extensive experience developing companion diagnostics and devices.
• Experience of drug development and drug regulatory procedures.
• Understanding of strategic and tactical role and deliverables of Global Regulatory Strategy in the Drug and Device Development and Commercialization process.
• Experience with developing and documenting regulatory strategies in coordination with clinical plans and marketing objectives. Experience with communicating the regulatory strategy, issues, and risks in written and verbal format to regulatory senior leadership team and other governing bodies required

Travel: Ability to travel up to 10% Occasional travel to Health Authority meetings in US and Europe, potentially Japan

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.