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. 

Senior Director, Clinical Research/Clinical Development

JOB DESCRIPTION: 

Reports to and works closely with VP of Clinical Development. Responsible for implementing the global Phase III program for the lead compound in close partnership with Clinical Operations. 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. With other relevant Allena functions, will also contribute to developing the strategy for development of follow-on compounds. This position works collaboratively with other Allena functions including Medical Affairs, Commercial, and Regulatory Affairs. 

Responsibilities: 

  • Serve as primary Medical / Scientific leader for the reloxaliase (formerly ALLN-177) program. In that capacity:
    • 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. 
    • Contribute to development of Phase III study-related documents and statistical analysis plans 
    • Partner closely with Clinical Operations to 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 medical and scientific questions from various internal and external sources 
  • Analyze and interpret data, 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 
  • Mentor junior team members 

Qualifications: 

  • MD is required, specialty in internal medicine or relevant subspecialty (nephrology or rheumatology, endocrinology ) or urology preferred, and /or significant experience in nephrology/ urology or related indications; minimum 5 years of pharmaceutical clinical research or other highly relevant clinical research experience (e.g., academic research) 
  • Knowledge of scientific principles of controlled clinical studies, and working 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.

Director/Associate Director, Medical Affairs

JOB DESCRIPTION: 

Allena Pharmaceuticals is recruiting for a professional with experience in conducting high level scientific and strategic interactions with external thought leaders and internal stakeholders, to join our team based in Newton MA. Reporting to the Vice President of Clinical Development, the Medical Affairs Associate Director/Director will provide strategic input to all medical affairs initiatives. S/he will be responsible for managing medical affairs activities including oversight of non-registrational studies, supporting clinical trial recruitment, developing and nurturing opinion leader relationships, helping to plan the medical affairs organization and managing data dissemination for reloxaliase (formerly ALLN-177), including publications, congress planning, and implementation of scientific communications. 

We are seeking a highly motivated individual who can work independently on a broad range of projects and will collaborate effectively with individuals across multiple functions including Clinical Research/Development, Clinical Operations, Business Development, Strategy and Commercial. 

Responsibilities: 

  • Scope out Allena medical affairs priorities and define medical affairs plans, gaining cross-functional input from clinical, regulatory, legal, commercial, etc. 
  • Develop compliant relationships with thought leaders and investigators, and cultivate partnerships with Advocacy Groups and other organizations. 
  • Support PI engagement and recruitment of Phase III studies, working closely with Clinical Development and Clinical Operations 
  • Plan and provide medical oversight of other Sponsored studies (e.g., Phase I, phase IV, registry, expanded access) 
  • Develop a deep scientific knowledge base of Allena products and their target disease states, and a solid understanding of the relevant physician communities and their practice patterns 
  • Keep abreast of scientific, disease state, emerging therapies and healthcare landscape information in order to provide medical leadership and insights to all Allena activities, collaborating cross-functionally 
  • Identify and engage with KOLs and other critical clinical stakeholders, harnessing critical insights and ensuring cross-functional alignment and coordination. 
  • Plan and participate in scientific meetings and conferences; synthesize scientific insights and communicate feedback gathered from scientific exchange to support medical affairs strategies 
  • Oversee and lead development of publication and congress plans that optimizes data dissemination for reloxaliase and other Allena pipeline assets. 
  • Lead the development and review of abstracts, oral presentations and other scientific publications for Allena assets, ensuring consistency of content and scientific messages across all communications. 
  • Handle day-to-day medical, and scientific questions from internal and external sources, and lead preparation of responses to medical information queries 
  • Identify, facilitate and track progress of data generation activities through investigator-initiated research (IIR) Studies 
  • Develop, plan and provide support for medical education activities, such as advisory boards, congress symposia, steering committees and stakeholder meetings. 
  • Maintains cross-functional collaboration with internal functions & field teams to provide scientific expertise and advisement to Clinical Research, Clinical Operations, Product Teams, Commercial, Corporate communications, etc. 
  • Actively participate in the development and oversight of the field based MSL team. 
  • Travel up to 50%, including overnight and weekend commitments. 

Qualifications: 

  • MD, PharmD, PhD or other advanced medical/scientific degree; experience in nephrology or urology preferred 
  • Minimum 5 years of pharmaceutical/biotech industry experience in related areas (Medical Affairs, Research & Development, Medical Science Liaison); experience with design and oversight of clinical trials a plus Excellent communication and presentation skills both written and verbal 
  • Experience with medical communications and publication planning and development 
  • Strong cross-functional orientation 
  • Excellent interpersonal skills with demonstrated track record and ability to drive results as an effective team member and project leader 
  • Flexibility and ability to adapt to changing conditions 
  • Excellent problem solving, organizational, and negotiating skills 
  • Motivated, self-starter who operates well in a smaller organization and is passionate about building medical affairs capabilities within an organization 

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 Project Manager/Senior Clinical Project Manager

POSITION SUMMARY: 

The CPM/Sr. CPM will play a key role within Clinical Operations in leading clinical study(ies) within timelines and budget scope, and with quality standards. The CPM/Sr.CPM will work closely with cross-functional colleagues and must thrive in a highly entrepreneurial biotech environment. 

RESPONSIBILITIES: 

  • Provide operational management of one or more assigned clinical projects with focus on clinical quality in accordance with FDA, EMEA, GCP, and ICH guidelines and the clinical protocol. 
  • Drive progress and operational excellence for clinical trials from planning to close-out, with focus on adherence to intended timelines and achievement of study deliverables. 
  • Guide vendor selection and management. 
  • Lead site identification and initiation, and patient recruitment strategies. 
  • Lead site training efforts; Plan and present at investigator meetings and vendor meetings. 
  • Manages vendor relationship and performance, including CROs and other vendors. Develop good working relationships with study site staff as required. Contribute to data reviews and CSR. 
  • Manage development of the study related documents, including clinical protocol, informed consent forms, study plans and other study specific clinical documents. 
  • Lead development of eCRF and specifications with data vendor. 
  • Lead cross functional study teams. Lead internal communication of project status. 
  • Track and report on progress of study metrics. 
  • Facilitate the development and implementation of remedial activities. 
  • Support the continued development of departmental practices and Standard Operating Procedures. 
  • Manage invoice review and support the accrual process. 

REQUIREMENTS: 

  • A BS/MS or higher in biological sciences or related field. 
  • Minimum of 5 years of directly related experience is desired. Proven experience in the oversight of the operational aspects of all stages of clinical studies. 
  • Progressive experience in management and conduct of clinical trials (e.g., ICH and regulatory requirements, drug development process, clinical trial material considerations, budgeting and forecasting, trial operational considerations, and clinical compliance). Expertise in monitoring operational functions and working knowledge of data management and cleaning. 
  • Late phase clinical trials and global experience preferred. 
  • Strong organizational/project management/interpersonal skills. 
  • Excellent written, oral/presentation and computer skills. 
  • Ability to travel up to 20 % of the time, as needed. 

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.

Process Development Engineer II

POSITION SUMMARY:

The Process Development engineer will design and execute experiments supporting the development, characterization, scale up and transfer of Allena’s manufacturing processes. They will perform basic biochemical analysis to evaluate the outcome of the process development experiments.  They will also be responsible for the evaluation and implementation of new and existing technology.  The process development engineer will perform the role of subject matter expert in evaluation of deviations, change controls and CAPA’s as required. 

KEY DUTIES:

  • Design and conduct experiments for advancing understanding and further developing the manufacturing processes for the drug substance.
  • Design and conduct experiments using a DOE approach to define the process design space and to characterize the process.
  • Determine the acceptable raw materials and product contact materials to be used in the manufacturing process
  • Perform basic biochemical analysis of the in process, drug substance and drug product using spectrophotometric, HPLC and PAGE techniques.
  • Conduct, analyze and interpret the results and plan future experiments based on the findings
  • Operate and maintain lab scale process equipment such as disk stack centrifuges, homogenizers and crystallizers.
  • Develop/build validated scale down models of the manufacturing process for the evaluation of change controls, deviation investigations and process validation activities as need.
  • Collaborate with manufacturing team to model novel unit operations at the bench and industrial scale in an effort to improve yield, maintain quality of molecule, decrease operating cycle time and enhance profitability.
  • Provide technical and/or logistical support to facilitate the development and launch of the company’s products.
  • Participate on the QRM team to determine and monitor the critical process parameters critical material attributes and key performance parameters.
  • Provide effective communication through verbal and written reports, timely updates, and knowledge sharing.

SKILLS/ABILITIES:

  • Follow good laboratory documentation practices while maintaining laboratory notebooks and other relevant documentation.
  • A technical background in the separation of biomolecules using techniques such flocculation, centrifugation, precipitation, crystallization, filtration as well as chromatographic methods.
  • Adaptable to work on a variety of projects from initial method scouting through to GMP manufacturing support.
  • Ability to summarize the result of work performed in the laboratory into presentations and reports 
  • Strong interpersonal skills and ability to work independently as well as on cross functional teams and with external vendors. 
  • Ability to travel up to 10% as needed. 
  • Preferred computer skills include MS Office applications, process modeling/simulation programs, statistical experimental design and data interpretation.

PERSONAL ATTRIBUTES:

  • Ability to work hard and contribute to an energetic working environment.
  • Willingness to learn new things.
  • Ability to function in a small company atmosphere.
  • Ability to cope with a rapidly changing work environment.
  • Commitment to teamwork.
  • Commitment to continuous improvement in all areas.
  • Ability to focus attention to details and ensure high quality work.
  • Ability to work safely; seek out and encourage safe practices.

EDUCATION AND EXPERIENCE:

  • BS in Biochemistry or Chemical Engineering with a minimum of 5 years of pharmaceutical development and/or manufacturing engineering experience.
  • Background or experience in physical chemistry/material science, crystallization, spray drying and pharmaceutical drug product manufacturing is a plus.

Manager, Contract Manufacturing

JOB DESCRIPTION:

Allena is seeking an experienced process scientist/engineer to join the Technical Operations – Contract Manufacturing organization for a position based at their Sudbury, MA site. The incumbent will lead technical operations activities in support of process design, scale-up, technical transfer and GMP manufacturing operations at our manufacturing partners.

The process engineer role will support global drug substance supply chain & manufacturing operations in cooperation with contract manufacturing organizations (CMO) with emphasis on fermentation and liquid solid separation techniques. This position supports the early, mid and late-stage development and GMP manufacturing activities for two of the company’s lead biopharmaceutical products. The successful candidate must be able to work in a dynamic environment, will have strong technical skills in a related field, and will have strong written and verbal communication skills. This position will require some travel during the site evaluation/selection, process technical transfer as well as during the initial phase of GMP manufacturing campaigns.

RESPONSIBILITIES:

  • Represent the company and/or lead process engineering projects in drug substance development, scale up and external manufacturing activities.
  • Work with the process development team to identify, review, and assess process unit operations in the effort to improve process consistency, reduce cost, and improve product quality.
  • Provide input to Process Development and third parties regarding feasibility of manufacturing methods.  Recommend process and equipment modifications to support process optimization, Technical Transfer and Scale-up. 
  • In conjunction with PD, develop and prepare new product introduction deliverables including gap analysis/fit evaluation, process overview documents, batch records, bill of materials, mass balance and sample plans. 
  • Design and conduct testing independently or working with CMOs to evaluate process KPPs and CPPs, processing equipment cleaning and sanitization, cost reduction initiatives, or manufacturing capacity strategies
  • Provide technical oversight/support during the manufacturing of demonstration and GMP DS production runs.
  • Support investigational activities in support of GMP operations, including review of investigational reports. Contribute to change control and process improvement initiatives as needed.
  • Responsible for process trend analysis- process monitoring for control and capability analysis.
  • Stay current with relevant technologies to identify opportunities for innovation to improve production outcome.
  • Provide effective communication through verbal and written reports, timely updates, and knowledge sharing.

REQUIREMENTS:

  • BS or MS in Chemical Engineering or Scientific Discipline with 5-8 years of development and/or manufacturing engineering experience (dependent on degree). A technical background in a combination of fermentation, solid- liquid separation is strongly desired.
  • Background or experience in physical chemistry/material science and pharmaceutical manufacturing is a plus
  • Experience in technical transfer, process characterization, GMP process support and data analysis are highly desired and are key aspects of this position.
  • Adaptable to work on a variety of projects from engineering design to product research and development to manufacturing.
  • Strong interpersonal skills and ability to work on cross-functional teams and external vendors.
  • Ability to travel up to 25% as needed.
  • Preferred computer skills include MS Office applications, process modeling/simulation programs.
  • Ability to represent Allena and the CMO effectively internally and externally through organized and effective presentations.

PERSONAL COMPETENCIES:

  • Collaboration
  • Effective communication
  • Accountability
  • Experienced interpersonal skills and effectiveness
  • Agility and flexibility

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.

 

 

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