Arcellx is a clinical-stage biopharmaceutical company developing adaptive and controllable cell therapies for the treatment of patients with cancer and autoimmune diseases. The Arcellx vision is to utilize its novel proprietary platform to bring superior cell therapies to more patients through the care of academic and community practices worldwide. The Arcellx team is developing superior immune cell therapies that are both adaptive and controllable throughout the course of disease Although the Company’s initial clinical focus is cancer therapy, Arcellx is committed to extending its Antigen- Receptor Complex T cell (ARC-T) therapies across a broad spectrum of human disease, including autoimmune conditions.
Launched in 2015 by an exemplary founding team, to date, the company has raised $114M with a syndicate of top tier investors, including New Enterprise Associates, Novo Holdings, SR One, Quan Capital and Aju IB Investment. At present, there are 40 full-time employees working at Arcellx.
Arcellx has a diverse pipeline of therapies that represent multiple blockbuster product opportunities. The lead clinical program in multiple myeloma is currently enrolling patients with preliminary data to be presented at ASH 2020. Two additional clinical candidates are expected to enter Ph1 in 2021. Several other candidates are in discovery or lead optimization. A more thorough description of Arcellx’s pipeline and platform technologies can be found at www.arcellx.com.
The company continues to make substantial investments in discovery of novel target binding domains to enable targeting of tumors, and diseased cell in non-oncology indications. Arcellx wholly owns the ARC-T + sparX platform and controls all related intellectual property. The company is focused on leveraging the platform internally to develop their own products, and externally through strategic industry partnerships. With its novel biology platform, blue-chip investors, stellar board and management team, Arcellx is well-positioned to become an innovative and leading, next-generation biopharmaceutical company.
Arcellx is seeking a Head of Clinical Development who will develop, lead and help drive the clinical development and overall R&D strategy of the company in partnership with the Chief Medical Officer. This individual will also be expected to cultivate relationships with key opinion leaders and members of the broader medical and scientific communities. The incumbent fulfills a critical and highly visible role, making substantial clinical and medical contributions to the company.
This position provides clinical input, including trial design and execution, medical monitoring, and regulatory submission preparation, managing the selection of clinical consultants and investigators.
The responsibilities include the review and refinement of the clinical development protocols and plans and works with colleagues in Clinical Operations and other Arcellx departments to ensure that the clinical goals for the company’s program are met.
Areas of specific responsibility and attention will include the following:
- Manage and help lead all translational medicine and clinical research activities at Arcellx from the pre-IND stage through full development
- Provide leadership and clinical perspective to the development and comprehensive regulatory strategies for Arcellx’s pipeline.
- Build and manage a high performing clinical team.
- Provide medical review, assessment and interpretation of all clinical data reported in clinical study reports to ensure that the data are presented with the appropriate medical interpretation.
- Monitor project deliverables from inception to completion and achieves high quality results that meet clinical end-points in a timely manner.
- Provide day-to-day practical and overarching strategic guidance for preclinical and clinical programs, ensuring that the design, implementation and conduct of the company’s clinical studies provide unambiguous data and information that allows for clear decision making and advancement of its developmental efforts.
- Act as the clinical representative at regulatory agencies.
- Contribute to authorship, review and approval of other key documents, including investigator brochures and INDs/CTAs as well as co-authored publications in scientific journals.
- Ensure seamless transition between research and clinical development by partnering with the preclinical development team to shape and define the development strategy for early assets.
- Maintain understanding of competitors and clinical developments in relevant therapeutic areas by attending scientific meetings, maintaining relationships with KOLs, and tracking literature.
- Represent and manage the company’s clinical programs to diverse audiences including regulatory agencies, the board of directors, and other key stakeholders.
- Provide consultative guidance on all medical-related matters to leaders across the company, as well as with outside scientific/medical/regulatory organizations, and KOLs.
- Recruit, motivate and develop a world class, highly innovative development organization. S/he will establish a culture that promotes creativity, open communication and collegiality.
- S/he will establish an effective clinical development reporting structure and management strategy.
- Responsible for effectively managing a cost budget, and delivering results based on predetermined performance goals.
The successful candidate will be a proven drug developer in oncology, with a minimum of 10 years’ experience in biotech or pharmaceutical industry. A record of accomplishment, including developing, planning, directing and designing clinical studies.
Seasoned drug hunter and organizational leader with experience building clinical stage oncology pipelines through both internal translational successes and in-licensing or partnerships.
Arcellx is committed to diversity of experience, skills, and backgrounds, and this individual will ideally serve as a champion for the development of women and minority talent.
Key requirements include:An MD or MD/PhD with strong leadership skills and proven biopharmaceutical industry experience in leading clinical development of early as well as mid-late stage therapeutic programs.
- A record of accomplishment including developing, planning, and designing clinical studies ideally leading to the successful registration of therapeutics.
- Experience with NDA/BLA submissions, ideally with oncology products, including formal interaction with regulatory agencies is preferred.
- Experienced in development of therapies for hematologic malignancies and solid tumors
- Experience with cell therapies preferred.
- Existing personal and professional relationships with key opinion leaders is desired.
- Proven track record of excellent interpersonal and communication skills with ability to relate to both internal and external stakeholders, develop strong positive relationship with senior management and provide leadership and guidance to high functioning clinical and regulatory team.
- Experience presenting to a wide variety of audiences including internal teams, Board of Directors, medical and scientific communities.
- Experience in developing successful collaborations with academic and industrial partners.
- Solid management skills and a good reputation for managing others to succeed.
- Builder and leader of exceptional clinical science teams.
- Ability to operate effectively within an entrepreneurial and science-driven company environment.
- A self-motivated, assertive, driven and hands-on individual.
- Sophisticated scientific management skills and business judgment with an ability to evaluate alternatives, establish priorities and apply resources effectively.
- Strong judgment and decision-making skills in making critical decisions while treating critically ill patients.
- Unquestionable integrity and highest ethical standards.
- Able to inspire people and stimulate creativity. Skilled at developing others and helping them navigate change and uncertainty.
- Exceptional interpersonal skills and a collaborative management style to facilitate interaction with the senior management team and other colleagues across all levels.
- Strong external presence with excellent written and verbal communication skills.
- Sound project, financial, and operational management capabilities.
An MD/PhD or MD in a relevant scientific/medical discipline is required. Training and experience in oncology is required, hematology oncology strongly preferred.
- Must have strong organizational skills and an ability to handle track and execute multiple priorities.
- Highly motivated, with willingness to acquire new skills and ability to learn quickly.
- Detail oriented, good documentation practices, technical writing and verbal communication skills
- Possess problem solving and analytical skills and be an independent and creative thinker.
- Ability to navigate and be successful in a fast-paced, highly matrixed work environment.
- Interpersonal and leadership skills to work with teams in different functions and organizations.