Head of Ex Vivo

Job Description: Head of Clinical Development, Ex Vivo Programs

How you will Achieve More with Intellia:

We are hiring a Head of Clinical Development for Ex Vivo Programs to oversee the allogeneic cell therapy programs (ex vivo programs), both internally and in partnerships. You will steer the development and execution of short and long-term medical plans supporting ex vivo cell therapy programs in both immuno-oncology and autoimmunity, aligning them with overall business goals. You will act as a Program Team Lead for an innovative new Ex Vivo Cell Therapy Program. A significant portion of time will be externally-facing, and the Head of Development Ex Vivo will provide therapeutic area/product expertise in oncological and autoimmune indications and understand both the patient’s and physician’s point of view. Working with cross-functional colleagues, you will ensure that the clinical development plan is in line with the brand strategies and helps support successful product development, medical launch, and commercialization.

Responsibilities:

• Oversee early and late-stage clinical development plans and execution of the ex vivo programs, including medical and registrational strategies and tactics for assigned clinical research projects.
• Manage the clinical development teams starting at the time of CTA/IND or proof of concept depending on the program, including all functions: clinical, regulatory, biostatistics, program management, clinical operations, tech ops/CMC, clinical pharmacology, research, and preclinical development, to design and execute clinical development plans for assigned projects.
• Provide clinical guidance in preparation of clinical protocols, regulatory documents, and regulatory agency interactions, including an active presence in internal governance and review committees.
• Play a key role in the development of analysis plans, and in the review, interpretation, and communication of clinical trial data, safety, and efficacy trials.
• Establish strong external networks of thought leaders in collaboration with members in medical, medical affairs, and Research and Early Development to support clinical development strategies and help optimize program plans and protocols.
• Ensure high-quality clinical trials that meet key milestones, maintain timelines, and ensure ongoing medical monitoring and oversight of clinical trial data and external data collection.
• Provide strategic perspective and guidance to Research and Early Development on decisions that may have significant clinical components and implications.
• Collaborate closely with Non-clinical, Clinical Development, Regulatory Affairs, Clinical Operations, CMC, and Biometrics to ensure tight strategic integration of development plans and strategies.
• Provide leadership, coaching, and mentorship to the clinical development team members and ensure their deliverables on key program and study metrics are met.

Program Team Leader, Ex Vivo Cell Therapy Program

• Accountable for the achievement of program milestones in scope, time, budget together with sub-team leads and functional leads that is aligned with corporate strategy.
• Ensures cross-functional plans are supporting the overall program strategy.
• Lead and work closely with the Program Manager to provide strategic, process, and operational leadership for the successful delivery of program goals and life-cycle management activities.
• Fosters high-performing team culture and cross-functional collaboration.
• Proactively responds to the dynamics of a changing competitive environment and challenges, facilitates adjustments in functional plans in response to changes in strategic direction.
• Ensures appropriate resourcing, support, and input from functions and coordinates with Functional Heads to align with business and program imperatives.
• Provide strategic and tactical leadership and support to sub-team leaders to set the vision and direction for the program(s) and execute on key deliverables.
• Reports on progress of program, plans, changes, critical path(s), issues and risk resolution and impact to the Executive Leadership Team.
• Support activities related to safety evaluations and reporting requirements.

Medical Leader across In Vivo and Ex Vivo Programs

• Ensures appropriate resourcing, support, and input from functions and coordinates with Functional Heads to align with business and program imperatives.
• Acts as a standing member of committees responsible for the conduct and quality of all clinical programs: Development Review Meeting for consideration of important development issues, Development Leadership Team for all leaders reporting to CMO, Safety Management Board for review of safety in all programs, Protocol Review Committee for review of all protocols and amendments as well as common issues across trials.
• Represents Intellia development for investor and analyst meetings, conducted with individual companies or with multiple companies. Addresses questions across the portfolio as well as clinical questions relating to the pipeline.
• Represents Intellia development at scientific meetings, presenting the Intellia effort across in vivo and ex vivo therapies as appropriate.

About You:

We are looking for candidates with a Doctoral degree (M.D) or foreign equivalent, with or without a Ph.D. with 12 years or more experience in drug development roles in a pharmaceutical industrial R&D setting. Additional role requirements include:

• Served as clinical and, ideally, strategic enterprise leader who has delivered in multiple phases of drug development (including clinical protocol development) and ability to deliver against challenging goals.
• Participated in key regulatory interactions with the FDA, EMA, or similar national agencies.
• Knowledge and experience in gene therapy and/or oncology and autoimmunity is preferred.
• Strong analytical and problem-solving skills.
• Excellent communicator; able to motivate others from a position of influence, negotiate conflict situations and forge consensus.
• Professional demeanor & strong stakeholder relationship skills when dealing with external customers (KOLs/regulatory bodies), internal colleagues, and Executive Leadership Team.
• Demonstrated successful ability to lead and manage complex developmental program teams in a cross-functional environment.

Meet your future team:

The Program Leadership Team at Intellia 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, project management, and regulatory affairs. We are here because we believe genome editing has incredible potential to treat and cure life-threatening and fatal diseases, and we believe that Intellia has the right people, strategy, and culture to do it well.

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. Your medical colleagues at Intellia are physicians/scientists who share responsibility across the three development-stage programs as Project Leads and Medical Leads. Their responsibility will increase in the coming years as Intellia’s pipeline moves further into clinical development.

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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.