We launched Atara Biotherapeutics in August 2012 to help patients with serious diseases and few therapeutic options to combat cancer and other serious illnesses. Our research is based on technology that enables the ability to harness and augment the immune system to stem disease. Our goal is to help patients, such as Atara Ciechanover, our company’s namesake, who suffered from cancer before passing away in 2012. We aim to empower patients to fight their illnesses with innovative treatment options.
The Director, Scientific Communications develops and executes a comprehensive scientific communication strategy and global publication plan for all AtaraBio’s development programs and products. The role collaborates closely with cross-functional teams to ensure that scientific and medical strategies are aligned with broader corporate, patient, physician, and payor needs. The Director should be well-versed in clinical practice and clinical research to deliver cutting edge data and technical/practical education to Health Care Professionals.
Reports to: SVP, Medical Affairs
Location: Preferably Westlake Village or South San Francisco, CA.
- Defines scientific communications and collaboration strategy to develop a comprehensive publication plan across the program life cycle that aligns with clinical and commercialization strategies.
- Coordinates execution of strategic publication plans to ensure alignment across departments.
- Ensures deliverables are met within set timelines including the development, approval and release of materials that support medical and scientific communications (i.e. reports, manuscripts, abstracts, posters, slide presentations and scientific symposia presentations).
- Builds global scientific communications team and function to support growth of AtaraBio’s programs.
- Monitors competitive literature, communications, and trials in order to predict competitive data release and optimizes strategic publication plan.
- Collaborates with internal medical writers, and manages external agencies to support the writing, editing, and submission of abstracts and articles to peer-reviewed scientific journals and scientific/medical conferences.
- Creates and implements policies and processes for compliant scientific communications and ensures all publication activities are in alignment with appropriate SOPs, strategic initiatives, and industry guidelines (eg, ICMJE, GPP3, CONSORT).
- Collaborates with R&D, Clinical, Legal, Commercial, Corporate Communications, Medical Affairs, Outcomes Research, and external stakeholders as needed to ensure that clinical and scientific data is represented accurately in published literature, slide decks and other materials.
- Participates in coordinating key scientific conference activities, including publications, symposium, advisory boards, sponsorship and booth activity.
- Develops and implements appropriate SOPs and strategic initiatives to improve efficiencies.
- Effectively builds relationships and works with global medical thought leaders.
- Manages the financial and contractual aspects of assigned projects, including vendor relationships.
- Prepares posters, developing content for scientific and educational programs, and working closely with KOL's.
- Leads key scientific communication projects and perform other responsibilities as assigned.
- Participates in long-range planning; develops and manages project plans, assess resource needs, investment planning and develop and implement processes and standards within the medical communication and publications expertise.
More About Atara Bio
We are a four-year-old approximately 100+ person publicly traded (NASDAQ exchange symbol ATRA) clinical-stage biopharmaceutical company focused on developing meaningful therapies for patients with severe and life-threatening diseases that have been underserved by scientific innovation. We are co-located by design in Westlake Village, CA (northwest LA) and South San Francisco, CA, with a process development lab in the Denver, CO area at the Fitzsimons Innovation Center and an office in New York City.
We are concentrating on developing allogeneic or third-party derived antigen-specific T-cells. T-cells are a type of white blood cell. Cytotoxic T-cells, otherwise known as cytotoxic T lymphocytes, or CTLs, can mount an immune response against an antigen or antigens to combat viral infection or disease.
Our most advanced T-cell product candidate, ATA129 (previously referred to as EBV-CTL), which is a third-party derived Epstein-Barr virus CTL, is currently being investigated for the treatment of Epstein-Barr virus, or EBV, associated post-transplant lymphoproliferative disorder, or EBV-PTLD. In immunocompromised patients, EBV causes lymphomas and other lymphoproliferative disorders, collectively called EBV-PTLD. EBV-PTLD most commonly affects patients after hematopoietic cell transplant, or HCT, or after solid organ transplant, or SOT.
In December 2016, we announced that we had reached agreement with the U.S. Food and Drug Administration, or FDA, on the designs of two Phase 3 trials for ATA129 intended to support approval in two separate indications, the treatment of rituximab-refractory EBV-PTLD after HCT and after SOT.
In February 2015, the FDA granted breakthrough therapy designation for ATA129 in the treatment of rituximab-refractory EBV-PTLD after HCT. Breakthrough therapy designation is an FDA process designed to accelerate the development and review of drugs intended to treat a serious condition when early trials show that the drug may be substantially better than current treatment. In February 2016, the FDA granted orphan drug designation for ATA129 for the treatment of patients with EBV-PTLD after HCT or SOT.
We are also pursing marketing approval of ATA129 in the European Union, or EU. In March 2016, the European Medicines Agency, or EMA, issued a positive opinion for orphan drug designation for ATA129 for the treatment of patients with EBV-PTLD. In October 2016, the EMA Committee for Medicinal Products for Human Use, or CHMP, and Committee for Advanced Therapies, or CAT, granted access to the EMA’s newly established Priority Medicines, or PRIME, regulatory initiative for ATA129 for the treatment of patients with rituximab refractory EBV-PTLD following HCT. PRIME provides early enhanced regulatory support to facilitate regulatory applications and accelerate the review of medicines that address a high unmet need.
In January 2017, we announced that pursuant to parallel scientific advice from the EMA’s Scientific Advice Working Group and several national Health Technology Assessment, or HTA, agencies in the EU, in 2018 we plan to submit an application for Conditional Marketing Authorization, or CMA, of ATA129 in the treatment of patients with rituximab refractory EBV-PTLD following HCT.
In addition to ATA 129, Atara Bio is in the process of bringing forward three other t-cell product candidates (ATA188, ATA520, ATA230 for indications ranging from Multiple Myeloma to Nasopharyngeal carcinoma to Multiple Sclerosis) that are in various trials.