Careers

Working Together Toward a Shared Vision

At Allena, we’re proud of our dynamic, thoughtful and engaging culture, and we are always looking for outstanding professionals to join our team.

We are innovators and collaborators. We fully appreciate our responsibility to the patients and to our stakeholder community, which is supporting our efforts to advance the development of novel oral enzyme therapeutics to treat complex metabolic complications.

Allena is currently seeking to fill the following positions. To be considered for a position, please complete the form below and send us your resume. 

Director/Associate Director Medical Writing and Scientific Communications

JOB DESCRIPTION: 

Allena Pharmaceuticals is recruiting for a professional with experience in scientific communications and medical writing to join our team based in Newton MA. We are seeking a highly motivated individual who can work collaboratively with individuals across multiple functions including Medical, Clinical Operations, Commercial, and Regulatory Affairs, and who will thrive in a highly entrepreneurial biotech environment. This role will be responsible for content development as well as overseeing external medical writing. 

Responsibilities: 

  • Acquire a medical/scientific knowledge base for Allena products and disease states. 
  • Develop content that is scientifically accurate, meets the stated strategic objectives of the project, and is at the appropriate level and tone for the intended audience(s), including press releases, abstracts/posters/manuscripts, slide presentations, training materials, etc. 
  • Liaise with Commercial and Medical/Clinical functions in publication planning. 
  • Source supporting references and annotate in accordance with project requirements. 
  • Contribute to or oversee the preparation of high quality clinical/regulatory documents including study protocols, clinical study reports, Investigator’s Brochures, relevant modules of regulatory dossiers, risk management plans, periodic reports, briefing books. 
  • Responsible for ensuring that written materials produced internally or externally are of high scientific and literary standards; as appropriate, undertake research in the therapeutic area, and engage Key Opinion Leaders and clinical investigators. 
  • Develop medical writing project timelines and plans; coordinate tasks, roles, responsibilities of authoring team, internal / external reviewers, QC, etc., to drive the process of document preparation and completion; manage document reviews and incorporate edits and resolve queries to produce a final document. 
  • Develop SOPs, work instructions, style guide, document templates, etc to ensure preparation of high quality medical-writing / medical communication deliverables that meet international (GPP, GCP) guidelines and requirements as appropriate, eliciting input from relevant functions (clinical development/medical affairs, commercial, regulatory, project management). 
  • Develop and maintain medical writing vendor relationships where required. Participate in bid defense, contract development, work alignment and / or operation meetings.

Qualifications: 

  • Minimum of a BA/BS in Science; Advanced degree in a health-related science desirable 
  • 3-5 years medical writing experience in pharmaceutical industry, including lead author of clinical and regulatory documents, experience with preparation of manuscripts and posters, etc. 
  • Excellent written and verbal communication; excellent grammar and proofreading skills and extremely detail-oriented 
  • Familiarity with eCTD format 
  • Proficiency in MS Office (Word, Excel, PowerPoint, Outlook) and other relevant products 
  • Proven ability to search PubMed to access scientific content, assess quality and relevance of publications, and summarize literature 
  • Ability to collaborate across departments and relate effectively to people at all levels of the company 
  • Highly organized, self-motivated, and extremely detail-oriented; Proven ability to work independently in a dynamic environment, and deliver high-quality products on time 
  • Excellent organizational/project management skills and a proven ability to multi-task 

Allena Pharmaceuticals is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law

Senior Director, Clinical Research/Clinical Development

JOB DESCRIPTION: 

Reports to and works closely with VP of Clinical Development. Responsible for developing and implementing the global strategy and tactical plans for the Phase III program for the lead compound. The Senior Director will engage and establish relationships with the medical and patient communities to inform and execute the Phase III Program, while ensuring strategic alignment of internal and external activities. This position works collaboratively with other Allena functions including Medical Affairs, Clinical Operations, Commercial, and Regulatory Affairs. 

Responsibilities: 

  • Serve as primary Medical leader for the ALLN-177 Program. In that capacity: o Develop and implement medical / scientific strategy through strong engagement and learning from medical/KOL and patient communities 
    • Participate in site identification and PI engagement, Investigator’s meetings, working closely with clinical operations personnel, CRO, etc. 
    • Develop Phase III and other study designs/protocols and statistical analysis plans 
    • Proactively identify program risks, and create and implement mitigation strategies 
    • Oversee and participate in ongoing safety monitoring and the interpretation/analysis of trial results including laboratory and biomarker data, review and approve trial coding. 
  • Oversee and contribute medical/scientific input to the preparation of clinical study reports, Investigational Brochures, statistical analysis plans including the ISS and ISE, periodic safety update reports, briefing documents, annual reports, IND, BLA and other regulatory documents 
  • Collaborate cross-functionally in strategic planning and contribute to preparation of the clinical development plan (CDP), product development plan, target product profile (TPP) and other corporate documents 
  • Handle day-to-day clinical, medical, and scientific questions from various internal and external sources 
  • Analyze and interpret data expertly, and clearly communicate results both internally and externally, through presentations, publications and education material 
  • Participate in preparation for and in meetings with the EMA, FDA, or other regulatory bodies 
  • Mentoring junior team members 

Qualifications: 

  • MD is required, board certification in nephrology or urology, or significant clinical trial experience in nephrology /urology indications; minimum 5-7 years of pharmaceutical clinical research or other highly relevant experience 
  • Knowledge of scientific principles of controlled clinical studies, and knowledge of GCP and FDA/ICH guidelines 
  • Demonstrated experience in clinical research and ability to meaningfully contribute to development strategy, critical review of data, generation of research hypotheses, publication and presentation of scientific information 
  • Exemplary written, verbal and electronic communications skills with diverse audiences 
  • Proven success working with and effectively supporting cross-functional teams 
  • Professionalism, objectiveness, critical thinking, evidence-based reasoning, and a positive outlook are essential 
  • Ability to travel up to 20-25% of the time 

Allena Pharmaceuticals is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.

Clinical Trial Associate

JOB DESCRIPTION: 

The Clinical Trial Associate (CTA) is responsible for assisting with execution of clinical trials while ensuring the trial is conducted in compliance with the protocol, ICH/GCP, applicable regulatory requirements and applicable SOPs/Work Instructions. The CTA is an in-house position. Responsible for assisting and providing support to the members of the clinical operations project team in order to facilitate the management clinical trial processes including planning, execution and closeout of outsourced clinical trials. The Clinical Trial Associate assists in the supporting the conduct of trials and may be responsible for managing specific study and operational tasks and hold vendor management responsibilities. 

RESPONSIBILITIES: 

  • Facilitate CDA & clinical trial agreement execution process and participates in site selection and startup activities 
  • Participate in creation and distribution of sponsor specific study aides/materials and communications 
  • Assists with the generation of study specific documents including protocols, study plans, and templates 
  • Review of clinical documents, ICFs, essential documents/IMP release packets 
  • Review and provide tracking oversight of Monitoring reports 
  • Support the development and design of CRFs, including participating in the EDC and IXRS specification process and UAT 
  • Under supervision of study manager or clinical lead, may assist with tasks typically associated with study management such as manage study vendor 
  • Liaise with Regulatory to support Clintrials.gov updates 
  • Responsible for agenda and minutes distribution for internal study team meetings 
  • Review of Trial Master Files 
  • Participate in data reviews 
  • Support invoice and budget activities 
  • Contribute to preparation of presentations 
  • Maintain up-to-date internal/external training as necessary 
  • May participate in site visits 
  • Performs other work-related duties as assigned 

REQUIREMENTS: 

  • Knowledgeable of clinical research operations, including interpretation and implementation of FDA regulations/ICH/GCP guidelines, is required 
  • Associates/Bachelor's degree and/or equivalent relative experience required 
  • Minimum 3-5 year's experience in supporting or managing tasks within a pharmaceutical/biotech or CRO setting. 
  • Strong interpersonal, organizational and multi-tasking skills; attention to detail 
  • Displays initiative and a maintains a solutions approach 
  • Adaptable to changing priorities, excels in fast-paced environment 
  • Perform job duties with minimal supervision and guidance 
  • Occasional Travel may be required (eg, 10%) 
  • Prior CTA or CRA (monitoring) experience preferred 

Allena Pharmaceuticals, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.

Quality Control Manager

 

 JOB DESCRIPTION: 

The QC Manager, reporting to the Sr. Director of Quality Control and Stability, will manage the day-to-day QC including method transfer, qualification, and validation, managing the testing activities at external contract laboratories, Assay Life Cycle management, Critical Materials management, and data review. This is an opportunity for the right individual to join the Allena team at a time where significant growth is occurring and the development of a scalable quality unit is key. He or she will help develop processes and procedures that reflect best practice and provide assurance that the products Allena releases to the clinic and future commercial market meet Allena’s high quality standards and FDA regulations. A high level of initiative, competence and professionalism is a key requirement. This role works across multiple departments, including Quality Assurance, Analytical Development, Supply Chain, Manufacturing, and Regulatory. 

Responsibilities: 

  • Support all QC functions related to GXP activities including authoring sops, protocols and reports supporting testing and method transfer and validation. 
  • Responsible for the management and monitoring of the progress of all QC testing activity and deliverables at CMOs and CTLs (including in-process, release and stability) and ensures complete documentation for compliance with cGMPs. 
  • Review release and stability data and provide feedback to both external and internal teams. Approve certificates of analysis received from contract laboratories. 
  • Author and review method transfer/qualification/validation protocols and reports 
  • Provide technical support for internal and external investigations, deviations, CC and CAPA activities. 
  • Perform trend analysis of testing data to establish release specifications for in-process and finished product 
  • Assist with preparation and review of IND and BLA submissions 
  • Assist the preparation, review and approval of Annual Reports 
  • Technical writing is critical as the candidate will be required to write new standard operating procedures (SOPs), protocols, reports, deviations and memos. 
  • The candidate will play key roles in all method transfers and validations. 
  • Support long-term planning of all QC lab capabilities and capacity. 
  • Responsible for coordinating with AD for the implementation of new technologies into the CTL network. 
  • The candidate must be able to troubleshoot issues and must work well in a team environment and be able to work across multiple departments. 
  • Assist in continuous improvement activities 

Qualifications: 

  • B.S/M.S. in life sciences, preferably Chemistry, with minimum of 5-10 years pharma/biotech QC experience 
  • A minimum of five years of hands-on QC laboratory experience in a GMP laboratory setting. 
  • Demonstrate conceptual and theoretical knowledge in chemical analysis methodologies, including methods common for biologics analysis including RP-HPLC, SEC-HPLC, SDS-PAGE, ELISA, Dissolution, in addition to compendial testing. 
  • Solid understanding of cGMP requirements and thorough knowledge of ICH method transfer and validations requirements. 
  • A comprehensive understanding of a Quality Control environment and GxP procedures is required. 
  • Experience reviewing and approving raw data, test results and Certificates of Analysis for raw materials, drug product intermediates and final product. 
  • Experience authoring, reviewing and approving method transfer and method validation protocols and reports 
  • A minimum of three years of experience working in companies that have an outsourced/ virtual business model 
  • Proven ability to work independently and effectively handle multiple priorities is a must. 
  • Excellent interpersonal skills, strong organizational skills and effective communication across all levels within an organization. 
  • Effective problem-solving skills and results orientated. 
  • Strong computer skills including knowledge of Empower, JMP, Excel, PowerPoint. 
  • The flexibility to travel to Allena’s contract laboratories when required. 

Allena Pharmaceuticals is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law

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