Associate Director, Medical Affairs (Scientific Communications/Publications)
Valid8 Financial, Inc., Frankfort, KY, United States
Associate Director, Medical Affairs (Scientific Communications / Publications)
Remote
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 patients’ 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.
This role can be remote (East Coast hours) or based out of our Philadelphia, PA headquarters.
We are seeking a detail-oriented and proactive
Associate Director, Medical Affairs
to support our Clinical/Medical/Regulatory (CMR) team in the efficient planning, preparation, and data dissemination at conferences and in journal publications. Reporting to the Senior Director, Medical Affairs, the ideal candidate will have a strong background in scientific writing, scientific conference management, publication planning, and project management within the biotechnology or pharmaceutical sectors.
Responsibilities
Manage the end-to-end process of publication planning, ensuring adherence to timelines and compliance with industry standards.
Collaborate with cross-functional teams, including Clinical Development, Translational Medicine, Computational Biology, Regulatory Affairs, and external authors/key opinion leaders, and vendors, to facilitate the development of manuscripts, abstracts, posters, and presentations.
Manage the operational execution and day-to-day budget for external medical writing and communications agencies that support content and publication deliverables.
Lead the preparation of journal manuscripts and abstracts and presentations for medical conferences, ensuring compliance with conference guidelines and requirements.
Advise teams regarding compliance with medical publications as defined in journal and congress guidelines.
Coordinate internal review processes and facilitate approval workflows for publications in collaboration with Legal, Compliance, and Medical teams.
Train internal teams on publications software and workflows.
Assist in the preparation of scientific content for medical conferences and other scientific forums.
Maintain awareness of industry trends and regulatory guidelines related to publication practices in the biopharmaceutical industry.
Develop and execute comprehensive scientific engagement strategies and congress plans (i.e. manage relationships with conference organizers, lead internal pre/post congress meetings, organize onsite HCP meetings, etc.).
Conduct literature searches and maintain databases of scientific publications relevant to cell therapy and related therapeutic areas.
Assist in the development and execution of medical affairs activities including advisory boards, internal trainings, patient advocacy group engagements, etc.
Ability to travel up to 25% to attend conferences and meetings.
Partner with cross functional teams to create integrated evidence generations plans.
Qualifications
Master’s degree in Health Care, Life Sciences, Biomedical Sciences, or a related field. Terminal degree in Life Sciences or healthcare (PharmD, PhD, MD, etc.) preferred.
>3 years of experience in medical affairs, scientific communications, or publication planning within the biotechnology or pharmaceutical industry.
Therapy area experience in rheumatology, neurology, immunology, and/or cell therapy
Experience working with publications management software/vendors (such as iEnvision, PubStrat, PubPro)
Experience managing a publications or asset/project budget including overseeing external vendors
Strong scientific writing skills with the ability to translate complex scientific data into clear and concise publications, including ability to analyze and interpret clinical trial data.
Knowledge of publication guidelines (e.g., ICMJE, GPP2022) and industry best practices.
Excellent organizational skills with the ability to manage multiple projects simultaneously and meet deadlines.
Proficiency in Microsoft 365 (Word, Excel, PowerPoint, OneNote)
Preferred: Certified Medical Publication Professional (CMPP) and ISMPP active member
Personal Attributes
Detail-oriented and meticulous in maintaining data integrity and publication records.
Strong interpersonal and communication skills to collaborate effectively with internal stakeholders and external authors.
Proactive and self-motivated with a strong sense of accountability and ownership.
Ability to thrive in a dynamic and fast-paced environment while maintaining high standards of quality and compliance.
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.
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.
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Remote
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 patients’ 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.
This role can be remote (East Coast hours) or based out of our Philadelphia, PA headquarters.
We are seeking a detail-oriented and proactive
Associate Director, Medical Affairs
to support our Clinical/Medical/Regulatory (CMR) team in the efficient planning, preparation, and data dissemination at conferences and in journal publications. Reporting to the Senior Director, Medical Affairs, the ideal candidate will have a strong background in scientific writing, scientific conference management, publication planning, and project management within the biotechnology or pharmaceutical sectors.
Responsibilities
Manage the end-to-end process of publication planning, ensuring adherence to timelines and compliance with industry standards.
Collaborate with cross-functional teams, including Clinical Development, Translational Medicine, Computational Biology, Regulatory Affairs, and external authors/key opinion leaders, and vendors, to facilitate the development of manuscripts, abstracts, posters, and presentations.
Manage the operational execution and day-to-day budget for external medical writing and communications agencies that support content and publication deliverables.
Lead the preparation of journal manuscripts and abstracts and presentations for medical conferences, ensuring compliance with conference guidelines and requirements.
Advise teams regarding compliance with medical publications as defined in journal and congress guidelines.
Coordinate internal review processes and facilitate approval workflows for publications in collaboration with Legal, Compliance, and Medical teams.
Train internal teams on publications software and workflows.
Assist in the preparation of scientific content for medical conferences and other scientific forums.
Maintain awareness of industry trends and regulatory guidelines related to publication practices in the biopharmaceutical industry.
Develop and execute comprehensive scientific engagement strategies and congress plans (i.e. manage relationships with conference organizers, lead internal pre/post congress meetings, organize onsite HCP meetings, etc.).
Conduct literature searches and maintain databases of scientific publications relevant to cell therapy and related therapeutic areas.
Assist in the development and execution of medical affairs activities including advisory boards, internal trainings, patient advocacy group engagements, etc.
Ability to travel up to 25% to attend conferences and meetings.
Partner with cross functional teams to create integrated evidence generations plans.
Qualifications
Master’s degree in Health Care, Life Sciences, Biomedical Sciences, or a related field. Terminal degree in Life Sciences or healthcare (PharmD, PhD, MD, etc.) preferred.
>3 years of experience in medical affairs, scientific communications, or publication planning within the biotechnology or pharmaceutical industry.
Therapy area experience in rheumatology, neurology, immunology, and/or cell therapy
Experience working with publications management software/vendors (such as iEnvision, PubStrat, PubPro)
Experience managing a publications or asset/project budget including overseeing external vendors
Strong scientific writing skills with the ability to translate complex scientific data into clear and concise publications, including ability to analyze and interpret clinical trial data.
Knowledge of publication guidelines (e.g., ICMJE, GPP2022) and industry best practices.
Excellent organizational skills with the ability to manage multiple projects simultaneously and meet deadlines.
Proficiency in Microsoft 365 (Word, Excel, PowerPoint, OneNote)
Preferred: Certified Medical Publication Professional (CMPP) and ISMPP active member
Personal Attributes
Detail-oriented and meticulous in maintaining data integrity and publication records.
Strong interpersonal and communication skills to collaborate effectively with internal stakeholders and external authors.
Proactive and self-motivated with a strong sense of accountability and ownership.
Ability to thrive in a dynamic and fast-paced environment while maintaining high standards of quality and compliance.
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.
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.
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