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Medical Director

3 months ago

Cambridge, United States Intellia Therapeutics Full time

Why Join Intellia?

Our mission is to develop curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases.

 

Beyond our science, we live our four core values: One, Explore, Disrupt, Deliver and feel strongly that you can achieve more at Intellia. We have a single-minded determination to excel and succeed together. We believe in the power of curiosity and pushing boundaries. We welcome challenging thoughts and imagination to develop innovative solutions. And we know that patients are counting on us to make the promise a reality, so we must maintain high standards and get it done.

 

We wantall ofour people to go beyond what is possible. We aren’t constrained by typical end rails, and we aren’t out to just “treat” people. We’re all in this for something more. We’re driven to cure and motivated for change. Just imagine the possibilities of what we can do together.

 

 

How you will Achieve More with Intellia:

 

Reporting to the Head of In Vivo Development, the Medical Director will serve as a medical expert for Intellia’s ATTR program and other cardiovascular indications as needed. In this role, you will work closely with Clinical Program Management, the ATTR-CM Clinical Development Lead (Senior Medical Director) and R&D Leadership as the medical monitor for Intellia ATTR clinical trials and will be responsible for evaluating data and extracting key insights from ongoing and completed clinical trials. As an expert in ATTR, the Medical Director will also participate in the preparation of publications and in the design of supportive ATTR studies. This role will contribute strategic medical and clinical trial expertise, prepare clinical trial and regulatory documents, build strong relationships with key opinion leaders and communicate development plans and study results internally and externally. This position will collaborate closely with other functional groups including, Clinical Operations, Regulatory Affairs, Discovery, Patient Advocacy and others.

 

Additional responsibilities for this role highlighted below:

  • Provide medical expertise for Intellia’sin vivogenome editing ATTR-CM clinical development program.

  • Act as Medical Monitor for ATTR-CM clinical trials.

Along with R&D Leadership and ATTR-CM Clinical Development Lead, Clinical Program Management, you will contribute to development plans (CDPs) and their execution.

Develop and maintain relationships with academic investigators, pharmaceutical partners/sponsors, KOL’s, and patient advocacy groups.

Contribute to activities in support of the company’s regulatory submissions, including authoring clinical sections for INDs, NDAs, and other related documents.

Partner with pharmacovigilance to best understand the safety profile of compounds.

Maintain a high level of clinical and scientific expertise in the disease area(s) by reviewing the literature, attending medical/scientific meetings, and through personal interchanges with consultants, thought leaders, investigators and internal stakeholders.

Author manuscripts and collaborate with cross-functional colleagues and thought leaders to meet publication plan objectives.

Maintain ethical standards of the highest level, with an absolute commitment to comply with all relevant ethical, regulatory, and legal strictures and the associated learnings thereof.

Lead/participate in clinical research due diligence in support of business development activity.

Interface with relevant functions (e.g. discovery, preclinical development, regulatory, clinical operations, etc.) to design and execute clinical development plans for assigned projects.

Provide medical information on existing and emerging data, in response to questions from internal and external stakeholders.

 

About You:

MD or MD/PhD with Cardiovascular Disease Board Certification; expertise in ATTR strongly preferred.

Strong clinical and scientific background with a good understanding of genetic concepts and molecular biology laboratory techniques

A minimum of 4+ years of pharmaceutical or biotechnology industry drug development experience required in clinical drug development and particularly in ATTR.

Must have multi-trial, Phase II/Phase III global experience.

Experience in the development of New Molecular Entities across multiple therapeutic areas or disease state/indications desirable, including life cycle management.

Experience in cellular and/or gene therapy and rare disease preferred.

Regulatory experience, including interactions with FDA/EMA and submitting INDs/IMPDs and NDAs/BLAs/MAAs

Experience running complex clinical research programs.

Team player with commitment to cross-functional working and yet, fully capable of independent working

Proven leadership through respect, example, knowledge and influence

Excellent verbal, written, and interpersonal communication and presentation skills.

 

#LI-SV1

 

 

Covid-19 Vaccination Policy:All Intellia employees, regardless of work location, are expected to follow all applicable federal, state, and local public health regulations and guidelines, and are strongly encouraged to follow all public health recommendations, including being vaccinated for COVID-19.

 

 

EEOC Statement: Intellia believes in a diverse environment, and is committed to equal employment opportunity for all its employees and qualified applicants. 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. Intellia will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.