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R

Medical Director, Clinical Development (CNS & Neuromuscular)

regenxbio · 30+ days ago

Remote

Negotiable

Full-time

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Who we are

REGENXBIO is an exceptional place to work. You'll have the opportunity to collaborate with some of the best and the brightest people, touch amazing science, and be a part of extraordinary plans. Our core values: Trust, Accountability, Perseverance, and Innovation drive everything we do. We aim to bring these values to life every day with all that we do, and we believe that what we do matters - to patients, to their families, and to their communities.

The opportunity:

As the Medical Director, Clinical Development (CNS & Neuromuscular), you will lead the development of a transformational gene therapy to treat MPS II and responsible for another development program in the future. You will be responsible for providing innovative scientific knowledge, skill, and technical expertise for assigned clinical programs and projects at REGENXBIO. You will play a key role is shepherding the candidate drug from pre-clinical stages through launch and lifecycle management.

What you'll be doing:

Accountable for clinical strategy, including the clinical development plan, and coordination of cross-functional execution of clinical strategy by the clinical sub teams.
Works in collaboration with external and internal experts to generate innovative development plans that create the best balance of time, resource and risk while ensuring the proposed plans align with the overall corporate strategy.
Represents clinical on the cross-functional program core team.
Accountable for clinical input and clinical sections of the Product Development Plan.
Accountable for clinical project timelines
Clinical core team representative presenting clinical development plans and recommendations to senior management and key stakeholders.
Chairs the Internal Safety committee monitoring clinical safety of clinical studies.
Accountable for overseeing medical monitoring to clinical studies.
Leads and/or participates in clinical/medical advisory panels and investigator meetings.
Contributes as author and provides clinical review of protocols, clinical study reports and publications.
Provides support to publication strategy for the projects/products assuring the highest standards of science, within product strategic needs and Compliance requirements. May work with academic investigators to present and publish clinical trial results at scientific meetings and in peer reviewed medical journals.
Remains up-to-date with current information on regulations, guidelines, and practices and therapeutic area knowledge and ensures consistent best practice across all activities.
Provides credible company representation in the academic Medical/Scientific Community to facilitate the constructive exchange of positions and ideas.
Develop and demonstrate expertise in data review and interpretation to deliver meaningful efficacy and safety conclusions.
Demonstrate the ability to interpret conclusions in context of product profiles and medical practice to create key messages, in collaboration with key stakeholders
Accountable for the adherence to Good Clinical Practice, data integrity principles and other key REGENXBIO policy requirements by external and contract partners
Responsible for traveling up to 25% of the time
It is imperative that REGENXBIO employees embody our core values by working collaboratively, building strong relationships and using clear communication to meet shared objectives.

What we're looking for:

M.D., Ph.D. or PharmD
Proven track record of experience and leadership in clinical trials/drug development
Practical experience including, development of clinical investigational protocols, implementation of protocols, interpretation of data, and interactions with regulatory bodies
Experience with gene or cell therapies and/or rare orphan diseases preferred
Excellent leadership skills
Deep knowledge of drug development from end to end
Ability to manage multiple and diverse internal/external collaborations at different stages of development
The ability to work well under intense pressure, tight timelines, and in rapidly changing situations
Evidence of an entrepreneurial spirit and a capacity to find creative solutions to unexpected hurdles
Interacts effectively across boundaries with supporting REGENXBIO functions and disciplines using influencing, communication and relationship building skills
Commitment to anticipate, influence and direct change
Excellent listening and collaboration skills

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Last updated on Nov 7, 2024

About the company

R

regenxbio

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