Director, Regulatory Affairs, Companion Diagnostics

Job Summary

Job Description

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

• 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: 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
• Contribute to shared learning forums, workshops and training on new guidances, regulations to enterprise
• Sharing case studies with enterprise

Qualifications

Education Qualifications

• Bachelor's Degree preferably in a scientific discipline required
• Advanced degree (e.g., Masters, Pharm.D., Ph.D., MD preferred

Experience Qualifications

• 7+ years relevant pharmaceutical experience including experience within Regulatory Affairs required
• Understanding of scientific content and complexities and good knowledge of diagnostic development, including extensive experience of IDE submissions and approvals required
• Extensive experience developing companion diagnostics and devices required
• 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 required

Travel Requirements
Ability to travel up to 10% of the time. Occasional travel to Health Authority meetings in US and Europe, potentially Japan.