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Company Overview

CRISPR Therapeutics is a leading gene editing company focused on developing transformative gene-based medicines for serious diseases using its proprietary CRISPR/Cas9 platform. CRISPR/Cas9 is a revolutionary gene editing technology that allows for precise, directed changes to genomic DNA. CRISPR Therapeutics has established a portfolio of therapeutic programs across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine and rare diseases. To accelerate and expand its efforts, CRISPR Therapeutics has established strategic partnerships with leading companies including Bayer, Vertex Pharmaceuticals and ViaCyte, Inc. CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc., and R&D operations in Boston, Massachusetts and San Francisco, California, and business offices in London, United Kingdom.

Position Summary

The Director/Senior Director of Medical Affairs for Leukemia and Lymphoma will report to the Executive Director of Medical Affairs. He/she will provide scientific and medical affairs leadership in support of compounds in various stages of clinical development. This individual will aid with the design and implementation of disease as well as product specific medical plans and scientific platforms, working in conjunction with their cross-functional peers in early development, translational medicine, and commercial. They will lead and coordinate the development of medical affairs program goals and strategies and translate them into appropriate tactics to improve patient outcomes, and access to medicines. Additionally, the Director/Senior Director will be responsible for content and execution of advisory boards, analysis of insights generated and utilizing that data to create/update open data questions required for product specific development plans. He/she will assist in the evaluation and support of investigator-initiated trials (IITs) and early access programs. The Director/Senior Director builds trust with the external scientific community via peer-to-peer engagement with scientific leaders, research and educational collaborations and publications. He/she will serve as a therapeutic area expert in scientific, strategic, and tactical discussions and presentations with internal colleagues, external stakeholders, health care providers (HCPs) and payor organizations. He/she will support the accurate and timely provision of medical information when requested.  This is a strategic as well as a tactical position with project-specific and future management-specific responsibilities.

Responsibilities

Leadership responsibilities:

• Represent Medical Affairs in cross functional teams/meetings including, but not limited to Project Teams, Clinical Sub-teams, and medical sub teams

• Lead Medical affairs cross-functional sub team meetings

• Lead advisory boards and steering committee meetings (as needed)

• Perform and/or coordinate research and analytics to provide recommendations to support decisions regarding life cycle management, clinical research, and internal planning

• Development of open data questions and evidence generation plans, with cross-functional peers, to support potential IIT programs, data generation and product life cycle management

• Represent company at professional meetings, congresses, and local symposia

• Identify, select, and manage future team members, external collaborations, vendors, profile organizations, and researchers with appropriate expertise

Deliverable responsibilities:

• Generate disease strategy and tactical plans appropriate for stage of disease specific pipeline products

• Partner with cross-functional departments on development of communication and publication strategy to address data disclosures, gap analysis, and key messages

• Work with internal and external stakeholders to build, refine, and update a comprehensive scientific platform

• Provide scientific and clinical leadership to the following (including but not limited to):

• Abstracts, posters, slides, manuscripts in disease area

• Educational materials in disease area including slides, webcasts, etc.

• Cooperative group proposals and CR&D study concepts

• IIT concept submissions

• Commercial Brand Plans, Integrated Disease Plans

• Scientific educational grant requests

• Patient advocacy grant requests in collaboration with cross-functional partners

• Regulatory submission documents

• Track priority Medical Affairs tactics and performance to goals/budget

• Engage/interact with key internal stakeholders including Clinical Research and Development, Biostatistics, Translational Development, Regulatory Affairs, Project Leadership, Marketing and Market Access and key external stakeholders including

• Respond to medical information requests in an accurate, compliant, and timely manner

Minimum Qualifications

• MD/DO/PhD/PharmD with at least 5 years of clinical or industry experience, previous Medical Affairs experience preferred

• Excellent analytical skills and solid experience in translating medical/clinical information into tactical activities and/or strategic plans

• Proficiency in scientific and clinical data review and interpretation

• Strong matrix leadership skills in cross-functional teams

• Strong organization skills

• Superior people skills

• Excellent oral and written communication skills, including presentations to large groups, facilitation of interactive discussions, and 1:1 discussion with thought leaders; demonstration of these activities within a virtual environment is a plus

• Experience creating and managing to a corporate budget

• Regular travel will be required (approx 20%)

Preferred Qualifications

• Expertise in oncology, hematology, or cardiovascular disease states

Competencies

• Collaborative – Openness, One Team

• Undaunted – Fearless, Can-do attitude

• Results Orientation – Delivering progress toward our mission. Sense of urgency in solving problems.

• Entrepreneurial Spirit – Proactive. Ownership mindset.

CRISPR Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.

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