Senior Medical Director, Clinical Development

Cambridge, MA, United States
Nov 23, 2020
Required Education
Position Type
Full time
Our mission:

Developing curative genome editing treatments that can positively transform the lives of people living with severe and life-threatening diseases.

At Intellia, we are committed to solving the complex challenges of making CRISPR/Cas9-based medicines a reality for patients suffering from genetic diseases and to create novel engineered cell therapies for immuno-oncological and autoimmune diseases.

Reporting to the Global Program Development Head, the Senior Medical Director will serve as a medical expert across Intellia Therapeutics global clinical programs that utilize in vivo genome editing. The Senior Director will co-lead with Clinical Program Management the in vivo genome editing Clinical sub-teams, and serve as the medical monitor for Phase I - IV clinical trials. This role will contribute strategic medical and clinical trial expertise into the development programs, 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.

    • Provide medical leadership across the Intellia's in vivo genome editing clinical development programs
    • Partner with Clinical Program Management to develop clinical development plans (CDPs) and co-lead the clinical sub-team to execute the CDP(s)
    • 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.

    • MD or MD/PhD with specialty Board Certification or Board Eligible
    • 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.
    • 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


What Intellia Stands For:

We push boundaries. We are focused on positively disrupting health care treatment of patients with genomic diseases. The values we live by and drivers we look for are:

- One is respect for individuals; our unique qualities and strengths; our own ways to understand, learn and improve. One is our single-minded determination to excel; to succeed together. One is you and us - trusting and counting on every single one of us.

- Explore because we seek new ways to tackle disease. Explore with unbounded from assumptions, open to ideas. Explore by staying curious, by pushing boundaries, overcoming obstacles. Explore means thinking of new ways.

- Disrupt by thinking courageously...and creating a better future. Disrupt by defying conformity; interrogating the status quo; questioning our momentum. Disrupt with challenging thoughts...with that breed of skepticism that shows you have better solutions.

- Deliver with your focus on the objective and your determination to complete the task. Deliver by advancing relentlessly and by maintaining high standards...even when nobody is watching. Deliver by staying accountable and pulling your weight. Deliver because patients are counting on us to make the promise reality. Get it done.

POSITION: Full-Time, Exempt

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.

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