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Sr. Medical Director, Clinical Development

Philadelphia, PA

Cabaletta Bio (Nasdaq: CABA) is a clinical-stage biotechnology company focused on developing and launching the first curative targeted cell therapies designed specifically for patients with autoimmune diseases. The CABA platform encompasses two complementary strategies which aim to advance the discovery and development of engineered T cell therapies with the potential to become deep and durable, perhaps curative, treatments for a broad range of autoimmune diseases. The lead CARTA (Chimeric Antigen Receptor T cells for Autoimmunity) strategy is prioritizing the development of rese-cel, a 4-1BB-containing fully human CD19-CAR T cell investigational therapy. Rese-cel is currently being evaluated in the RESET (REstoring SElf-Tolerance) clinical development program spanning multiple therapeutic areas, including rheumatology, neurology and dermatology. Cabaletta Bio's headquarters and labs are located in Philadelphia, PA. For more information, please visit www.cabalettabio.com

and connect with us on LinkedIn.

Uniquely Differentiated. Rapid. Elegant.

At Cabaletta, we are driven by the shared mission of developing cures, where a patient's own cells are used to fight disease. We are building a culture grounded in the knowledge that successful cures can be achieved for patients if every member of the Cabaletta is focused on the success of the team. To nurture this, we make an active commitment to the well-being and continuous growth of each employee who joins the team. In this way, we are not only working to improve the lives of patients, but of everyone involved. #CabalettaCrew. 

We're proud to be a Great Place to Work-Certified company! #GPTWcertified Check out what our employees say makes working here so great:  Working at Cabaletta Bio Inc | Great Place to Work

Position Description:               

This role can be remote or based out of our Philadelphia, PA headquarters.  East Coast candidates are preferred.  Travel of 10-20% required.

Cabaletta is seeking an experienced, highly motivated hands-on physician leader to serve as a Senior Medical Director, Clinical Development reporting to the VP, Clinical Development. This individual will provide the medical oversight and leadership of Cabaletta's cell therapy programs in autoimmune diseases, including collaborating with the clinical operations, regulatory, translational research, manufacturing, and quality assurance functions; liaising with clinical investigators and site personnel; establishing and building relationships with key external experts; and interacting with Health Authority representatives, such as the FDA. The position requires a leader with significant experience working with CROs and vendors and interfacing with investigator sites to ensure operational efficiency and effective execution of trials within a complex, fast-paced environment.

Key Responsibilities:

• Provide medical leadership for various programs from first-in-human studies through registrational studies. Late-stage development experience is preferrable
• Formulate study designs, lead protocol development, partner with internal cross-functional teams in study start-up activities, and collaborate with clinical investigators, key external experts, and Health Authorities
• Participate in direct, hands-on involvement in all aspects of study conduct clinical activities, working with clinical operations, including data review, analysis, and reporting that conform to the ethical, safety, and quality standards of Cabaletta, GCP, and Health Authorities
• Become an expert and remain current in the relevant therapeutic areas and in the field of cell and gene therapy through review of the scientific literature, interactions with key external experts, and attendance at relevant scientific meetings
• Actively contribute during Health Authority interactions
• Review available preclinical data that could inform the design of future clinical trials
• Present at site evaluation and site initiation visits as applicable
• In partnership with relevant cross-functional team members, actively engage in the preparation of Clinical Study Reports, Annual Reports and other safety reports, Health Authority pre-meeting packages, Investigator Brochures, periodic clinical reports, and BLA submission documents
• Collaborating with cross-functional groups, formulate publication strategy including active participation in authoring, preparation and review of manuscripts, conference abstracts and presentations and other external presentations of clinical data

Qualifications:

• M.D., M.D./Ph.D. degree or equivalent required
• Board Certification, Board Eligibility, or clinical experience in the field of Rheumatology and/or Immunology highly desirable
• 7+ years of experience in clinical research, including the design and execution of complex clinical trials, with a pharmaceutical or biotech company
• Experience with or exposure to the development of adoptive cell therapies or biologic therapies is desirable
• Experience with Health Authority interactions and submission of clinical regulatory documents is desirable
• Strong written and verbal communication skills; ability to easily engage with investigators and key external experts; and ability to effectively present at conferences, advisory meetings, and other public for a
• Engaged, hands-on, independent, and goal-oriented mentality; willingness to work in highly dynamic work environment
• Ability to multi-task and willingness to flexibly contribute simultaneously to multiple facets of drug development; willingness to learn new therapeutic areas and technologies
• Self-motivated, innovative, and critical thinker with strong commitment to follow up on action items; strong organizational, analytical, and problem-solving skills
• Strong influencing skills and ability to create a clear sense of direction
• Thrives in a fast-paced small company environment and able to adjust priorities and workload based upon changing needs
• Comfortable with ambiguity and ability to define processes and procedures from scratch
• Strong team orientation and passion for continuous self-development
• Ability and willingness to travel as required

Our name - Cabaletta - is derived from the operatic term that represents a rapid, repetitive, and technically challenging section of an operatic aria, designed to showcase the skills of the lead singer. Analogously, Cabaletta Bio strives to achieve rapid and repetitive product development, building on our indication prioritization and biologic platform that targets the driver of specific autoimmune diseases without the need for long-term immunosuppression.

For more information, please visit  https://www.cabalettabio.com/join-our-crew

Our most important asset is our people, and we offer competitive benefits, PTO, and stock option plans.

Cabaletta Bio is an equal opportunity employer. We do not discriminate on the basis of race, color, gender, gender identity, sexual orientation, age, religion, national or ethnic origin, disability, protected veteran status or any other basis protected by applicable law.

Cabaletta Bio, Inc. does not accept unsolicited resumes from recruiters, employment agencies, or staffing firms. To conduct business with Cabaletta, a Master Services Agreement (MSA) must be executed and confirmed prior to submitting any information relating to a potential candidate. Without a signed MSA, Cabaletta shall not be responsible to any individual or entity for any payment relating to any form of fee or compensation.

And, if a resume or candidate is submitted by a recruiter, an employment agency, or a staffing firm without a fully executed MSA, Cabaletta has the unrestricted right to pursue and hire any of those candidate(s) without any legal or financial responsibility to the recruiter, agency, and/or firm.

#LI-REMOTE