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.
Executive Director, Medical Governance & Strategic CapabilitiesWhy JoinIntellia?
Our mission is to developcurativegenome 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. Wearen’tconstrained by typical end rails, and wearen’tout to just “treat” people.We’reall in this for something more.We’redriven to cure and motivated for change. Just imagine the possibilities of what we can do together.How you will Achieve More with Intellia:
As the Executive Director, Medical Governance & Strategic Capabilities you will be a member of the Medical Affairs Leadership Team and report to the Head of Medical Affairs (HMA). The successful candidate will play a key role in the establishment of a Global Medical Affairs organization, along with global and regional department policies and practices. The position is key to the design and implementation of the Intellia Medical Affairs (MA) governance structure and processes, while leading the operational execution of the MA strategic plans. The Executive Director, Medical Governance & Strategic Capabilities uses knowledge across several disciplines to drive key MA initiatives across the Intellia portfolio, partnering with other Clinical Development and Intellia teams to develop and execute integrated global medical plans. You will be responsible for the MA internal and external resource management, product planning, sourcing, medical communications, external medical engagement (societies, healthcare systems, government and payer stakeholders) as well as medical compliance and risk management. You will be responsible for:
- Partnering with the Head of MA to develop and implement the vision, mission, objectives, and strategy for the MA organization
- In partnership with the Program Teams and , will oversee the design and the development of medical communication plans (publications, HCP and HCS engagement plans, product/therapeutic advisory boards, medical symposia and congress activities, etc.).
- Develops and works to continually improve Medical Affairs’ governance and infrastructure, including development of SOPs, best practices, as well as training and workshops of MA associates.
- Medical input and management of budgets for MA programs, including clinical grants and medical education support activities.
- Accountable for MA Compliance initiatives, policy interpretations, risk mitigation, trainings, and corrective actions, in collaboration with compliance and clinical QA functions.Support Head of Medical Affairs in the oversight of strategic planning, setting metrics, operations execution, budgeting, strategic sourcing and vendor engagement, and process improvements.
- Analyze and assess MA capabilities, processes, systems to identify gaps within Medical Affairs to maximize value, operational efficiency and compliance aligned with strategic priorities.
- Collaborate across key Intellia’s line functions (Development, New Product Planning, Safety, etc.) to build fully integrated MA plans for priority development candidates.
- Provide direction, oversight and coordination of complex activities within the MA team in support of priority programs.
- Work with Program Teams to ensure full integration of MA plans with the overall global product strategy, resulting in one Integrated Product Plan that uniquely addresses patient needs.
- Oversight of the global MA near- and long-term product strategy and plan implementation.
- Oversight of MA operational excellence and quality key performance indicators with direct communications to the Development Leadership Team regarding expectations for strategic planning, and business alignment.
- Partner and collaborate with various line functions such as Outsourcing, Legal, IT, Compliance, and Commercial organization to simplify business process, maximize productivity, and minimize risk of non-compliance.
You are a key Medical Affairs leader who would embrace the challenge to create an innovative national and global Medical Affairs approach to Intellia’s CRISPR/cas9 programs.Qualifications:
Meet your future team:
- MSc, MBA preferred with significant (>15y) experience in Medical Affairs, Medical Technology and/or Medical Strategy in the biotechnology/pharmaceutical/medical device industry.
- Experience in Medical Affairs leadership for products addressing rare disease and/or harnessing gene editing biology.
- Minimum of 10 years of experience in direct project management, working in Medical Affairs, Drug Development or Clinical Research.
- Demonstrated track record of executing medical and/or scientific plans in support of product development and differentiation, addressing healthcare stakeholder requirements, and clinical practice patterns on a national and global level.
- Demonstrated ability in strategic planning, resource management and budget reporting.
- Strong technical and operational experience in planning, executing, reporting and publishing clinical and pre-clinical research.
- Demonstrated ability to lead and motivate a team; experience leading cross-functional teams and vendors/consultants.
- Demonstrated ability to present complex issues to upper-level management and contribute to executive level presentations and discussions.
- Excellent and demonstrated interpersonal skills: ability to understand and respond to multiple external and internal customers’ demands, manage and handle conflict constructively required.
- Strong knowledge and application of ICH GCP, GxP, global regulations and good document management practices.
- Demonstrated success working in a fast paced, matrixed, growing organization; successful in partnering with multiple internal & external stakeholders.
The Clinical Development Team at Intellia is here because we believe genome editing has incredible potential to treat and cure life-threatening and fatal diseases, and we believe the Intellia has the right people, strategy, and culture to do it well. It is made up of one or more people in functions related to clinical research, including but not limited to biometrics, clinical operations, clinical pharmacology, medical science, medical writing, project leadership, project management, and regulatory affairs.The team is led by our CMO, a physician and medical oncologist with over 25 years of experience in large pharma and biotech drug development. Other senior team members have 10 or more years of similar experience, including many with prior direct experience in nucleic acid therapeutics and cell therapy.#LI-KO2
Covid-19 Vaccination Policy: All Intellia employees, regardless of work location, must be fully vaccinated for COVID-19. This requirement includes a booster dose once eligible. Requests for exemption for medical or sincerely held religious beliefs will be considered.
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.