US-MA, Early Development Regulatory Director 201419BR-MZ
Early Development Regulatory Director
Global Drug Development
Global Develop NPH
Research & Development
Early Development Regulatory Director (EDRD) provides regulatory leadership for early projects (pre-first in human) in the Novartis Institute of Biomedical Research (NIBR) portfolio This individual functions as a core member of Early Development Teams to define the optimal regulatory strategy for first in human studies and work with franchise Regulatory Affairs to develop an expedient path to proof of concept (POC) that also enables full development. The EDRD will have cross franchise project responsibility through sPOC and planning for first in human (pre-IND meetings, etc.) and the work with the franchise DRA and DRA operations to optimize strategies from first in man to Development Decision Point (DDP). The EDRD serves as a regulatory expert for NIBR and early development teams to assure an understanding of regulatory process and compliance. The EDRD supports NIBR driven licensing activities and biomarker strategies, and provides internal regulatory advice to NIBR on compliance and operational issues.
Develop regulatory strategies for projects in the NIBR portfolio (both small molecule and biologics programs) assuring regulatory guidance is provided to teams from the time of candidate selection through first in man/POC. Assure a smooth transition of all programs into the development portfolio, across business franchises in general medicines.
Provide global regulatory direction and evaluate regulatory risks/gaps and trade-offs for the overall ED development plan with a focus on efficient global planning for first in human studies. Develop contingency plans for identified risks in the regulatory strategy.
Follow closely industry and health authority actions and guidance's in novel technologies, such as advanced cell therapies, assuring the NIBR scientists and teams have a state of the art understanding of the current regulatory environment in these fast moving fields, actively participate in NIBR scientific forums to share critical learning.
Work with Development DRA leadership and NIBR teams to align project milestones and risk benefit analyses with the goals of assuring a smooth transition from NIBR to development for all programs, both internal and in-licensing opportunities.
Drive global approaches to early development strategies, considering novel approaches to timely POC outcomes. Provide regulatory guidance on biomarker strategies. Lead interactions with regulatory consultants for strategic input and challenges, particularly for novel technologies and therapeutic approaches.
Provide regulatory input into NIBR driven licensing activities including technologies and M&A proposals, assuring regulatory risks are identified. Take regulatory lead on transition teams as ap-propriate.
Assure understanding of regulatory compliance/best practice in the NIBR organization, identify training needs as appropriate training. Assure an operational understanding of the Novartis regulatory process is in place in Novartis Institute Biomedical Research ( NIBRI) teams, identify gaps that require training.
Health Authority Interactions
Develop global regulatory strategy and plans for Health Authority (HA) interactions for all Early Development programs including pre-IND meetings, country selection for first in human studies and biomarker strategic discussions.
Work with the Regulatory Affaris Franchise Heads to take leadership in providing regulatory guidance to DADB and NIBR leadership on strategies for early HA interactions, proposed meetings, timelines, country selection.
Take a lead in preparing briefing books for Early Development HA meetings, leading the meetings and communicating key outcomes to both NIBR and Development
Take the lead in interacting with HA s on both informal and formal questions relating to NIBR programs, assuring timely responses to HA questions to facilitate program timelines.
Work with the TA DRA representatives to assure a well defined IND/CTA submission planning process for first in human and other early trials, in collaboration with the Development DRA franchise and DRA operations.
Provide strong scientific guidance as well as regulatory strategy for submissions; determine which submission procedures to utilize; provide strategic review of IND/CTA s including preclinical safety, clinical and CMC sections.
Assure excellent communications between the NIBR teams and NVS DRA Operations to expedite the filing process.
Identify issues, gaps, options and trade-offs for development plan leading to an optimal and timely submission and approval of IND s and minimize clinical holds and other delays.
Assure regulatory guidance and expertise to early development teams on biomarker qualification strategies and preparation for and implementation of biomarker meetings with FDA, EMEA, and other HA.
Accountable for ensuring regulatory compliance for all NIBR assigned programs.
Management of indirect reports, interface with DRA operational and BF DRA staff.
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
PharmD, MD or PhD in Life Sciences, Pharmacy or Medicine, or equivalent experience. Prefer a strong background in molecular biology, biochemistry, pharmacology or toxicology. Experience in discovery research, preclinical pharmacology drug development in the ophthalmology or infectious disease area is a plus.
Fluency in English (oral and written
8-10 years of involvement in regulatory and drug/biologic development spanning activities from preclinical development through Phases I-IV in most or all of the following areas:
Prior history in early development strategies, expertise in biologics preferred.
Innovation in regulatory strategy.
Involvement in an IND/CTA submissions and approval.
Leadership role in HA negotiations in multiple regions, particularly for early programs.
Working knowledge of biomarker development strategies and regulatory process for qualification.
Demonstrated understanding of critical development concerns for therapeutic protein and advanced cell therapies, knowledge of regulatory guidance/industry best practice for development.
Working knowledge of development issues for preclinical and comparability strategies for biologic products.
Regulatory operational expertise.
2-5 years of demonstrated leadership and accomplishment in regulatory affairs in a global/matrix environment in the pharmaceutical industry.
2-5 years additional drug development experience, including chemistry, pharmacology or toxicology experience.
Global people management experience desirable.
Strong presentation, interpersonal, communication, negotiation and problem solving skills.
Considerable organizational awareness (e.g., interrelationship of departments, business priorities), including significant experience working cross functionally and in global teams.
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