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. 

Executive Assistant and Office Manager

JOB DESCRIPTION: 

Allena Pharmaceuticals is seeking a highly motivated and energetic professional to provide administrative support to Allena’s Executive Leadership Team and manage day-to-day office operations. 

Responsibilities: 

  • Support the Executive Leadership Team through calendar management (planning and scheduling meetings, conferences, teleconferences), coordinating domestic and international travel and preparing expense reports 
  • Handle business, company, and personnel details of a confidential and sensitive nature while engaging with key executive-level external constituencies, including investors, analysts, and the press 
  • Work closely with Board of Directors and their assistants for Board and Board Committee meetings 
  • Proactively create and maintain effective communication and workflow, which includes handling of a variety of projects and tasks simultaneously 
  • Assist in the design and preparation of corporate materials and presentations including the creation, editing and assembly of slides for presentations 
  • Support operations by managing administrative functions and mentoring/supervising administrative staff to ensure the office runs efficiently 
  • Manage day-to-day interactions with vendors including facilities, purchasing, IT, HR, finance, and legal service providers. Order office/lab supplies 
  • Cultivate and contribute to company camaraderie and culture as Allena continues to grow 
  • Plan and organize company-wide events/outings. 

Qualifications: 

  • Eight to ten years of relevant work experience, with 3-5 years in support of C-level executives. Biotech/pharma experience and/or experience in a start-up or rapid-growth company a plus. 
  • Ability to actively manage a wide range of tasks and the flexibility to shift priorities rapidly. Willingness to perform other tasks as assigned. 
  • Excellent interpersonal skills. Ability to work collaboratively in a highly dynamic, fast-paced environment. 
  • Self-motivated, enthusiastic and results oriented; strong level of initiative and ability to work with minimal supervision. 
  • Excellent verbal/written communication, organization and time management skills. 
  • Expertise with MS Office, with particular proficiency in PowerPoint. 

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.

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

 

 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.

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