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.

To be considered for one of the positions below, please complete the form below and send us your resume. 

Quality Assurance Specialist

Description

Quality Assurance Specialist will support the organization by ensuring conformance to established quality assurance processes and standards while actively working to continuously improve them. In this position you will be responsible for providing support for internal and external quality activities through control of documentation, tracking and maintenance of QMS, review and verification of analytical and technical reports and batch documentation, formatting and editing of controlled documents and administration of controlled documents within Veeva Vault. This position involves quality experience working with regulatory filings and the ability to review documents and data that will support the regulatory filings for clinical/commercial processes.

Responsibilities:  

Document control administration 

  • Process, track and retrieve SOPs, protocols, reports, policies, etc. and manage and track associated periodic reviews and training using Veeva Vault electronic document management system

Maintain Quality Systems

  • Assist with the maintenance of Internal Quality Systems including deviation control, change control, document control, inspection readiness, OOS/OOT, CAPA/quality issue management, internal and external audits, management review and training programs

QA representative on cross-functional teams

  • Interface with internal and external stakeholders to address and resolve product and process related issues.

Review batch related documentation

  • Review and approve CMO/CTL documents including: Master and executed batch records in support of drug substance and drug product manufacture; test methods and data in support of release and stability testing; Process Validation Protocols and Reports; Documents associated with deviations, investigations, OOS results, and CAPA action plans 

Ensure documentation meets established requirements for cGxPs, internal SOPs, and company policies

  • Know and apply technical and quality concepts, applicable guidelines of the FDA or other regulatory bodies and relevant SOPs

Manages the review and approval of qualification, validation and tech transfer activities

  • Review analytical and process development technical reports and verification/review of associated data.  Review of analytical method development and qualification/validation data, protocols and reports

Edit and file GxP documentation as required and maintain organization of GxP File Room

  • Perform word processing tasks and support in the revision and formatting of documents. Check format and conformance to document templates, verifies own work. Perform archival and retrieval of GxP Documentation.

Perform other duties as assigned

  • Responsibilities also include providing support for regulatory submissions related to clinical and commercial products and support for review of GCP and GLP related documents. 

Skills/Abilities:

  • Understanding and knowledge of FDA Guidelines and GxP regulations.
  • Must be highly proficient in MS Office Suite.
  • High proficiency in Veeva Vault: required.
  • Must be self-directed and able to function under general supervision and also be able to adjust to fluctuating assignments and workloads.
  • Demonstrates general knowledge of the processes and impact of document control, and the relationship between the document change process and products.

Competencies:

Results orientated: Sets challenging yet achievable goals; pursues them persistently, overcome obstacles while focusing on meeting or exceeding these goals. Plans out work, organizes resources and monitors progress. Has a strong desire for Allena, own team, and self to succeed.

  • Constantly pushes self for best results 
  • Demonstrates a “can-do” spirit 
  • Figures out the process necessary to get things done
  • Monitor process, progress and results
  • Understand how to separate and combine tasks into efficient work flow
  • Works tirelessly to meets goals successfully

Communication: Promotes a smooth flow of information and communication throughout Allena. Communicates effectively and often with all audiences. Openly shares knowledge and expertise. Listens actively and encourages others to express their ideas and opinions.

  • Ask questions in order to confirm understanding 
  • Effective communicator in a formal setting: one-on-one, small and large groups, with peers and bosses
  • Has good judgment as to what information is significant and useable in each situation
  • Listens to feedback, comments from superiors and colleagues
  • Organizes ideas in a clear, logical flow that can easily be followed by the audience
  • Practices effective listening skills
  • Shares information with others regularly and often to promote free flow of information
  • Writes and speaks clearly and succinctly in a variety of communication settings

Collaboration: Develops and uses collaborative relationships to facilitate the accomplishment of work goals. Fosters collaboration among team members and among teams. Involves others in decisions and plans and credits them for their contributions and accomplishments. Fosters enthusiasm and maintains mutual trust, candor and respect.

  • Uses team approach to solve problems when appropriate
  • Understands the dynamic of the group in terms of positions, roles, expectations and needs
  • Works with other units/teams/functions to accomplish goals
  • Learns new skills and knowledge and shares that with the team
  • Encourages collaboration and is cooperative
  • Shares best practices and knowledge with others

Education and Experience:

  • Associate degree in science and minimum of 5 years of appropriate experience in GMP regulated environment, preferred.
  • Bachelor's degree Library Science or biotechnology with 2 years of appropriate work experience in GMP regulated environment, preferred.

Location: Newton or Sudbury, MA

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, Process Development

Description:

The Director of Process Development will establish the strategy, project plans, and timelines for internal/external process development efforts to characterize and optimize the late-stage Reloxaliase process as a lead-in to process validation, commercialization and process monitoring. Additionally, the Director of Process Development will grow the PD function within the company and lead the creation of subsequent manufacturing processes for clinical candidate compounds with an emphasis on translating academic/R&D processes into scalable, robust methods suitable for industry and subsequent technology transfer into a GMP manufacturing environment.

The individual chosen for this role will work in close partnership within a matrixed environment by regularly interfacing with diverse teams and functions including MSAT, Quality, Regulatory, Legal, Analytical Development, and Program Management.

Responsibilities:  

The Director of PD will be responsible for primarily downstream PD activities with some peripheral involvement in upstream development activities. Those duties include:

  • Assessing and refining the strategy for Allena’s PD group with an immediate focus on completing the actual process development and “locking” the process to be used for GMP runs and PPQ (process validation) of our lead candidate
  • Working closely with other necessary department heads to develop a tech transfer plan for processes coming from PD and moving into GMP manufacturing
  • Lead an internal team consisting of Analytical Development, MSAT and External Manufacturing to determine a robust Process Performance Qualification (PPQ) protocol strategy, to include generation of appropriate acceptance criteria
  • Responsible for the all stages of process development for all programs within the pipeline
  • Oversee the development and implementation of an (upstream and downstream) process monitoring/control strategy program using appropriate statistical guidelines
  • Provide expert and scientific input into the development and implementation of drug substance and drug product release specifications 
  • Leads authoring efforts for specific CMC sections of regulatory filings (including INDs, BLA’s, and formal responses to regulatory inquiries)
  • Drives innovation from ideation to realization for process improvements, including definition of technology roadmap, justification of projects, and developing implementation plans.
  • Support business cases and CAPEX justifications for capacity expansion, facility build-outs and acquisitions
  • Participates in planning to ensure alignment between resource availability and project pipeline 

Skills/Abilities:

  • A demonstrated self-starter who is excited by the challenge of commercializing a late-stage product and values the direct impact he/she will have on the lives of our patients
  • Willing and able to work at whatever operational level needed to meet the goals of the function 
  • Highly motivated and ability to take a proactive approach on the job
  • Has a solid understanding of business and financial fundamentals
  • Willing to challenge the status quo and provide creative solutions to identified challenges

Competencies:

Results orientated: Sets challenging yet achievable goals; pursues them persistently, overcome obstacles while focusing on meeting or exceeding these goals. Plans out work, organizes resources and monitors progress. Has a strong desire for Allena, own team, and self to succeed.

  • Constantly pushes self for best results 
  • Demonstrates a “can-do” spirit 
  • Figures out the process necessary to get things done
  • Monitor process, progress and results
  • Understand how to separate and combine tasks into efficient work flow
  • Works tirelessly to meets goals successfully

Communication: Promotes a smooth flow of information and communication throughout Allena. Communicates effectively and often with all audiences. Openly shares knowledge and expertise. Listens actively and encourages others to express their ideas and opinions.

  • Ask questions in order to confirm understanding 
  • Effective communicator in a formal setting: one-on-one, small and large groups, with peers and bosses
  • Has good judgment as to what information is significant and useable in each situation
  • Listens to feedback, comments from superiors and colleagues
  • Organizes ideas in a clear, logical flow that can easily be followed by the audience
  • Practices effective listening skills
  • Shares information with others regularly and often to promote free flow of information
  • Writes and speaks clearly and succinctly in a variety of communication settings

Collaboration: Develops and uses collaborative relationships to facilitate the accomplishment of work goals. Fosters collaboration among team members and among teams. Involves others in decisions and plans and credits them for their contributions and accomplishments. Fosters enthusiasm and maintains mutual trust, candor and respect.

  • Uses team approach to solve problems when appropriate
  • Understands the dynamic of the group in terms of positions, roles, expectations and needs
  • Works with other units/teams/functions to accomplish goals
  • Learns new skills and knowledge and shares that with the team
  • Encourages collaboration and is cooperative
  • Shares best practices and knowledge with others

Education and Experience:

  • PhD in a life science and 5-7 years of experience in large-molecule, biologics-related PD, an MS and 10 years of experience, or a BS/BA and 12 years of experience 
  • Must have expertise in and be able to demonstrate a deep understanding of end-to-end bioprocessing strategies to include the current state of the art analytical tools used to evaluate them
  • Has a deep technical understanding of large-molecule and large-scale manufacturing platforms
  • Demonstrated experience in late-stage product development including execution of product risk assessments, implementation of Quality by Design and integration of RA and QbD into process validation protocols and BLA submissions
  • An excellent leader with experience managing teams of high-performing PD scientists/engineers

Location: Sudbury, MA

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, External Manufacturing (Drug Substance)

Description

The Director of External Manufacturing (Drug Substance), will form a key part of a vital External Manufacturing & Operations function. This function is growing to meet the business needs of Allena’s maturing CMO network. This role manages the operational relationship with multiple Contract Manufacturing Organizations (CMOs) in preparation for commercialization of the company’s lead product. The Director is responsible for operations performance of all external manufacturing within Allena’s Commercial Contract Manufacturing Organization (CMO) network under their remit. This role partners with both internal and CMO functional peers to ensure adherence to Allena’s manufacturing standards, budgets, outputs and schedules.  The Director will lead and coordinate multiple cross-functional operations teams to ensure CMO manufacturing is proactively supported. The role is responsible for establishing strategy, implementing actions, reporting status, identifying / mitigating risks and driving a culture of continuous improvement. The role drives for excellence in PAI and routine cGMP Inspection performance and will support the development of BLA, NDA and other regulatory filings.

Who are we looking for?

  • An External Manufacturing/Drug Substance Leader who loves working on multiple projects in a fast-paced, cross-functional team environment
  • Minimum of bachelor’s degree in Life Sciences discipline appropriate to cell therapy programs (immunology, cell biology, genetic engineering, etc.)
  • 10+ years of experience working in biopharmaceutical manufacturing, technical operations, supply chain, or process development. Fluency in cGMP requirements.

What are we looking for?

  • Leading the way:  A creative and learning-agile leader, willing to challenge the status quo
  • Ownership:  A partner to jointly own our company’s goals, execution and success
  • Working together:  A colleague to thrive on collaboration with our teammates
  • Loving what you do:  A team member with positive energy that is passionate about our mission

What are we offering?

  • Membership within a growing, CARING and collegial organization
  • Exposure to pioneering science of the therapies that utilize the GI tract to degrade metabolites
  • Unique opportunity to help develop the platform and strategy of an expanding company
  • Manager who is a proven mentor and coach
  • Career support and leadership opportunities within the CMC group

Responsibilities:  

  • Lead and direct Allena and CMO cross-functional tiered meeting structures to ensure business objectives and manufacturing, supply and quality deliverables are met.
  • Ensure issues are effectively resolved and that supply risks are being proactively managed
  • Build and maintain strong relationships with CMO and internal peers to develop and deliver shared objectives
  • Ensure timely escalation of issues and risks as relevant to appropriate stakeholders
  • Provide operational expertise to support all aspects of the manufacturing of commercial and late stage clinical pharmaceutical products at CMOs
  • Develop, maintain and communicate suitable KPIs to measure CMO / Allena performance to ensure business and patient supply needs are achieved
  • Lead troubleshooting efforts and high-level deviation investigations in conjunction with CMOs and internal partners
  • Support the Allena executive teams at Joint Steering Committee (lJSC) meetings where appropriate. Drive internal cross functional alignment on key issues as outcome of these CMO engagement meetings
  • Identify manufacturing best practices across the network and lead or participate in teams to implement best practices
  • Support identification and implementation of continuous improvement initiatives within the External Manufacturing & Operations team
  • Work closely with internal peers to adopt, promote and improve the External Manufacturing & Operations model
  • As needed support CMO due diligence during new CMO selection to vet capabilities, risks and investments required
  • Engage, as needed, in contract negotiation and review. After execution of a contract, act as contract monitor, ensuring both Allena and the CMO comply with commitments.
  • Provide regulatory filing support (IND, BLA, etc.)
  • Inventory management (in partnership with Drug Product/Supply Chain)
  • Drive a continuous improvement mindset (e.g. process improvements: throughput, cycle time, robustness)
  • Maintain financial responsibility for CMO spend, managing the budget allocation, negotiating work statements, ensuring purchase requisitions are raised and PO’s are reconciled 
  • Oversee change management (pre- and post-approval), ensuring owners are identified and change controls are raised and assessed in a timely manner.

Skills/Abilities:

  • Extensive knowledge of a variety of drug substance manufacturing unit operations used in USP and DSP of large molecule products from microbial fermentation. Prefer candidates with microfiltration and ultrafiltration experience
  • Comprehensive understanding of cGMP requirements for clinical and commercial manufacturing
  • Ability to present and defend technical aspects of manufacturing operations during regulatory agency inspections
  • Demonstrated experience with technology transfers and scale-up of manufacturing processes
  • Experience of working with CMOs demonstrating strong communication and influencing skills
  • Ability to demonstrate strategic thinking and risk management
  • Systems and process development, optimization and implementation

Competencies:

Passion for Innovation: Generates and champions new ideas, approaches, and initiatives, and creates an environment that nurtures and supports innovation. Leverages knowledge and best practices, fresh perspectives, breakthrough ideas, and new paradigms to create value. Encourages new ways of looking at problems, processes, or solutions.

Planning: Creates a comprehensive and realistic business plans by defining deliverables, milestones, accountabilities and measures of success to achieve objectives, while ensuring the optimal use of resources to meet efficiency, requests and due dates. Allocates appropriate amounts of time for completing own work. Prioritize critical and less critical activities. Proactively plans to avoid problems.

Collaboration: ls and promotes collaboration and works effectively with others across the organization to achieve goals. Demonstrates proficient cross company communication, cultural sensitivity, and partnership in interactions with others.  Involves others in decisions and plans and credits them for their contributions and accomplishments.

Adaptability: Responds resourcefully, flexibly and positively when faced with new challenges, transitions and demands. Willingly and effectively deals with the stress and complexities of various situations. Moves forward productively and optimistically under conditions of change and uncertainty. 

Execution: Drives execution of strategic and operating plans while maintaining operational effectiveness.  Conveys a strong sense of urgency around continuous improvement, achieving high quality results, and accelerating business performance.  Addresses problems directly and drives changes necessary to achieve business objectives.

Education and Experience:

  • Bachelor’s degree in Life Sciences discipline appropriate to cell therapy programs (immunology, cell biology, genetic engineering, etc.)
  • 10+ years of experience working in biopharmaceutical manufacturing, technical operations, supply chain, or process development. Fluent in cGMP requirements
  • Demonstrated ability to lead matrix teams
  • Demonstrated experience in management of external partners

Location: Sudbury, MA

Travel: 20%+ (routine travel to CMO sites)

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.

Scientist, Process Development

Description

Allena is seeking a highly skilled and motivated Scientist to reside in Allena’s Process Development organization in Sudbury, MA. This role will support both the early-phase process development of Allena’s pipeline products and process characterization of the company’s late-stage lead product. The applicant should have strong communication and collaboration skills, along with multiple examples of strong technical contribution in large molecule downstream process development.

Who are we looking for?

  • Innovative scientist who will help Allena’s Process Development team in execution of their goals
  • MS degree in biochemistry, chemistry, chemical engineering, bioengineering, or related area with 3-4 years of industry experience/or Ph.D. degree in biochemistry, chemistry, chemical engineering, bioengineering, or related area with 1-2 years industry experience 
  • 3+ years of downstream process development experience of the biologics, such as viral vectors, monoclonal antibodies, vaccines, and therapeutic recombinant proteins in the biopharma industry 

What are we looking for?

  • Leading the way:  A creative and learning-agile scientist, willing to challenge the status quo
  • Ownership:  A partner to jointly own our company’s goals, execution and success
  • Working together:  A colleague to thrive on collaboration with our teammates
  • Loving what you do:  A team member with positive energy that is passionate about our mission

What are we offering?

  • Membership within a growing, CARING and collegial organization
  • Exposure to pioneering science of the therapies that utilize the GI tract to degrade metabolites
  • Unique opportunity to help develop the platform and strategy of an expanding company
  • Manager who is a proven mentor and coach
  • Career support and leadership opportunities within the CMC group

Responsibilities:  

  • Design and execute development studies to evaluate new technologies, improve existing technologies and assist in the implementation of new/improved processes for clinical and commercial product purification
  • Lead or support the development of 2nd generation downstream process for the late phase programs 
  • Lead and execute late-phase process characterization activities including: risk assessments, scale down model qualification, pre-characterization and characterization experiments, impurity clearance studies, and development of the PPQ and commercial process control strategy
  • Support process transfer and scale up 
  • Apply engineering concepts to the screening, optimization and scale-up of solids isolation/removal and filtration processes including microfiltration, depth filtration, ultrafiltration, diafiltration, and sterile filtration
  • Collaborate within cross-functional teams (Analytical Development, MSAT, Quality, and External Manufacturing) to deliver required CMC activities
  • Generate, manage, evaluate, and maintain critical data in a highly organized manner 
  • Author technical reports, process descriptions, study protocols and reports, risk assessment documents, process characterization documents, and control strategy documents
  • Prepare scientific presentations as needed 
  • Support regulatory filings and response to health authority questions. Author and review CMC sections for IND and BLA submissions

Skills/Abilities:

  • Deep knowledge and understanding of downstream process of biologics is required with emphasis on filtration methods preferred
  • Experiences of large scale GmP manufacturing and GXP compliant documentation is beneficial
  • Strong written and oral communication skills
  • Strong data organization skills, interpretation and troubleshooting are critical to be successful

Competencies:

Planning: Creates a comprehensive and realistic business plans by defining deliverables, milestones, accountabilities and measures of success to achieve objectives, while ensuring the optimal use of resources to meet efficiency, requests and due dates. Allocates appropriate amounts of time for completing own work. Prioritize critical and less critical activities. Proactively plans to avoid problems.

Collaboration: ls and promotes collaboration and works effectively with others across the organization to achieve goals. Demonstrates proficient cross company communication, cultural sensitivity, and partnership in interactions with others.  Involves others in decisions and plans and credits them for their contributions and accomplishments.

Adaptability: Responds resourcefully, flexibly and positively when faced with new challenges, transitions and demands. Willingly and effectively deals with the stress and complexities of various situations. Moves forward productively and optimistically under conditions of change and uncertainty. 

Execution: Drives execution of strategic and operating plans while maintaining operational effectiveness.  Conveys a strong sense of urgency around continuous improvement, achieving high quality results, and accelerating business performance.  Addresses problems directly and drives changes necessary to achieve business objectives.

Education and Experience:

  • MS degree in biochemistry, chemistry, chemical engineering, bioengineering, or related area with 3-4 years of industry experience/or Ph.D. degree in biochemistry, chemistry, chemical engineering, bioengineering, or related area with 1-2 years industry experience is required
  • 3+ years of downstream process development experience of the biologics, such as viral vectors, monoclonal antibodies, vaccines, and therapeutic recombinant proteins in the biopharma industry is required

Location: Sudbury, MA

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.

Executive Director/Senior Director Quality Assurance

Description

This position is a key senior leadership role at Allena, reporting directly to the SVP of Technical Operations. The Executive / Senior Director of Quality is responsible for establishing, enhancing and managing the Allena quality and compliance activities within Allena and across a network of outside contractors (CRO, CDO, CMO) responsible for development, ongoing manufacture and eventual commercialization of Allena’s products. This role will operate at an executive level to define the strategy for product quality management at Allena across both early-stage and late-stage clinical products. The primary responsibilities of the position are to prepare the company for preapproval inspection and commercialization while simultaneously developing and refining quality systems and building/leading a small organization to prepare for inspection and oversee product quality at all 3rd party contractors, while ensuring high levels of quality and service to internal customers, positive experience of staff, and meeting departmental initiatives. The ideal candidate for this role is an experienced, natural self-starter with strong organizational skills that thrives in a busy, fast-paced environment, and who can communicate effectively with executive leaders and key leaders from external partners and customers.

Who are we looking for?

  • Innovative Quality leader to lead our strong, reliable and high performing QA team
  • Must be versed in all relevant GMP and GLP guidance with preference to candidates with GCP experience as well.
  • Strong preference for candidates with CFR 210/211, EMEA Annex 1 experience, in addition.
  • Leader with 15+ years minimum experience in the Quality/Supplier Quality field in life sciences, pharma or biotech.

What are we looking for?

  • Leading the way:  A creative and learning-agile QA leader, willing to challenge the status quo
  • Ownership:  A partner to jointly own our company’s goals, execution and success
  • Working together:  A colleague to thrive on collaboration with our teammates
  • Loving what you do:  A team member with positive energy that is passionate about our mission

What are we offering?

  • Exposure to pioneering science of the therapies that utilize the GI tract to degrade metabolites
  • Unique opportunity to help develop the platform and strategy of an expanding company
  • Manager who is a proven mentor and coach
  • Career support and leadership opportunities within the CMC group
  • Membership within a growing, CARING and collegial organization

Responsibilities:  

  • Enhancing and maturing the vision for corporate quality at Allena as an emerging biotech.
  • Act as key strategic driver in integrating the role of quality into the business with the executive committee.
  • Lead a cross functional group at establishing an industry standard quality system that interfaces with all key business components.
  • Develop a mid-term roadmap for preapproval inspection and oversee the development of a team that will manage execution on the plan.
  • Help oversee the development of a nimble, risked-focused quality system architecture that can flex across different clinical stage products, risk profiles, and sources/CMOs.
  • Drive QBD initiatives into product development to help enable best practices in building manufacturable products.
  • Represent Allena quality in all partner / customer interactions.
  • Define quality policy and cross-company RACI matrix.
  • Develop a best in class program for supplier management and auditing, as well as internal audit management.
  • Oversee the ongoing management of the Quality Document Control and the sourcing, design, and implementation of a comprehensive Quality Management system.
  • Enhance, drive and report on the CAPA/OOS/OOT and investigations programs.
  • Mature the quality governance system that tracks the business with internal and external KPI’s and holds departments/CXOs accountable on deliverables.
  • Ensuring management of changes associated with products and processes are carried out appropriately using science and risk-based assessment to determine the impact of change.
  • Monitoring, communicating and acting on any emerging compliance trends that may potentially impact on product quality.
  • Provide direction and mentorship to management staff.
  • Oversees departmental product issues and commits resources to understand root cause root and appropriate corrections.
  • Select, train/orients and schedules department staff. Develops standards of performance, evaluates KPIs, and initiates or makes recommendations for personnel actions.
  • Provide regular KPIs and other metrics to senior management.

Skills/Abilities:

  • Must be versed in all relevant GMP and GLP guidance with preference to candidates with GCP experience as well.
  • Strong preference for candidates with CFR 210/211, EMEA Annex 1 experience, in addition.
  • Experience with large-molecule, fermentation-derived products is a plus.
  • Excellent communication skills, both written and verbal.
  • Demonstrated skills in problem identification, analysis and resolution.
  • Demonstrated ability to assess needs, train and supervise staff.
  • May have had department-level leadership responsibilities with a commercial company.
  • Strong preference for candidates with global experience.

Competencies:

Planning: Creates a comprehensive and realistic business plans by defining deliverables, milestones, accountabilities and measures of success to achieve objectives, while ensuring the optimal use of resources to meet efficiency, requests and due dates. Allocates appropriate amounts of time for completing own work. Prioritize critical and less critical activities. Proactively plans to avoid problems.

Collaboration: ls and promotes collaboration and works effectively with others across the organization to achieve goals. Demonstrates proficient cross company communication, cultural sensitivity, and partnership in interactions with others.  Involves others in decisions and plans and credits them for their contributions and accomplishments.

Adaptability: Responds resourcefully, flexibly and positively when faced with new challenges, transitions and demands. Willingly and effectively deals with the stress and complexities of various situations. Moves forward productively and optimistically under conditions of change and uncertainty. 

Execution: Drives execution of strategic and operating plans while maintaining operational effectiveness.  Conveys a strong sense of urgency around continuous improvement, achieving high quality results, and accelerating business performance.  Addresses problems directly and drives changes necessary to achieve business objectives.

Education and Experience:

  • Bachelors degree in scientific discipline (Biology, Chemistry, Engineering), MS/PhD a plus
  • 15+ years minimum experience in the Quality/Supplier Quality field in life sciences, pharma or biotech
  • 15 years in leadership roles in increasing responsibility
  • 3+ years experience in senior/direct-line position at an organization that underwent PAI and/or regular audits by customers / regulatory agencies required

Location: Sudbury, MA

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.

VP of Clinical Operations

Description

The Vice President of Clinical Operations will be responsible for the strategic oversight, execution (within budget and timelines), compliance and day-to-day management of the clinical operations team, as well as CRO management for investigational and marketed products. She/he will identify and drive strategic initiatives for clinical trial planning, execution, close out, and continuous process improvements. The Vice President will be accountable for the line management of Clinical Operations Team members, including development, coaching, and talent planning and performance management. 

Who are we looking for?

  • Innovative VP of Clinical Operations who will help Allena’s Clinical Operations team in execution of their goals.
  • Ideally a minimum of 15 years of directly related experience in drug development, including running multiple concurrent large global phase 3 trials and NDA/BLA regulatory filing experience.
  • Significant management experience including outsourcing to Contract Research Organizations (CROs) and other clinical trial vendors.

What are we looking for?

  • Leading the way:  A creative and learning-agile clinical leader, willing to challenge the status quo
  • Ownership:  A partner to jointly own our company’s goals, execution and success
  • Working together:  A colleague to thrive on collaboration with our teammates
  • Loving what you do:  A team member with positive energy that is passionate about our mission

What are we offering?

  • Primary strategic leadership role for overall clinical operations activity and execution of global clinical trials in alignment with Program Team goals
  • Membership within a growing, CARING and collegial organization
  • Exposure to pioneering science of the therapies that utilize the GI tract to degrade metabolites
  • Unique opportunity to help develop the platform and strategy of an expanding company

Responsibilities:  

  • Manages vendors and consultants relevant to the supported function (such as statistics, medical writing), including consulting agreements, contracts and related budgets and invoicing.  Specifically, responsible for managing the Duke Clinical Research Institute (DCRI) collaboration, and non-clinical trial research projects (such as OM-1 database research project); may support expanded access program. 
  • Manages selected meetings, including scheduling, preparing meeting minutes, timelines, tracking action items, driving deliverables; works with colleagues across projects and functions to understand and take into consideration cross-project overlap and existing resources within CD/MA to streamline their activities and deliverables. 
  • Identifies critical resource gaps and suggests and implements solutions and mitigation; will provide direct hands-on assistance as needed. 
  • Prepares or assists in the preparation of presentations to internal and external stakeholders and supports/manages the preparation of abstract/posters/manuscripts and other documents with internal reviewers and external contributors (e.g., external medical writing, authors); contributes content as appropriate, consolidates comments and resolves issues. 
  • Coordinates/assists with preparation for Advisory Board meetings, Allena presence at national and/or regional scientific meetings; includes supporting logistical management of vendors, investigators, Allena personnel at academic/scientific meetings and attending meetings.
  • Gains and maintains knowledge of therapeutic area and current medical practice; helps with hands-on consolidation/organization of data to support medical functions and business development.

Skills/Abilities:

  • Manage reports up through Executive Director Level within the Clinical Operations line function: attract as needed, supervise, mentor and ensure high performance of Clinical Operations staff. Ensure appropriate and high performing staffing of the line function to meet clinical deliverables. Evaluate resource requirements, including people and develop efficient and comprehensive resourcing plans across all clinical studies.

Competencies:

Adaptability: Responds resourcefully, flexibly, and positively when faced with new challenges, transitions, and demands. Willingly and effectively deals with the stress and complexities of various situations. Moves forward productively and optimistically under conditions of change and uncertainty.

Collaboration: Embodies and promotes collaboration and works effectively with others across the organization to achieve goals. Demonstrates proficient cross-company communication, cultural sensitivity, and partnership in interactions with others.  Involves others in decisions and plans and credits them for their contributions and accomplishments.

Communication: Creates an environment which promotes the free flow of communication and information throughout the organization. Communicates effectively in large and small groups. Openly shares knowledge and expertise. Listens actively and encourages the open expression of ideas and opinions.

Execution: Drives execution of strategic and operating plans while maintaining operational effectiveness. Conveys a strong sense of urgency around continuous improvement, achieving high quality results, and accelerating business performance. Addresses problems directly and drives changes necessary to achieve business objectives. 

Relationship Building: Establishes and maintains strong relationships internally and externally. Respects and relates well to management, colleagues, peers, and direct reports. Champions a culture of respect, diversity and inclusion that values and respects individuals. Earns the respect of others through principled leadership, sound business ethics, and authenticity.

People Development: Creates comprehensive and robust talent plans, talent pools, and bench strength within the organization. Ensures that talent receives feedback, mentoring, training and development opportunities. Shapes roles and assignments in ways that leverage and develop individual’s capabilities. ​

Education and Experience:

  • BS/BA degree in related discipline and 20 years of related experience; or,
  • MS/MA/MBA degree in related discipline and 15 years of related experience; or,
  • PhD in related discipline and 12 years of related experience.
  • Ideally a minimum of 15 years of directly related experience in drug development, including running multiple concurrent large global phase 3 trials and NDA/BLA regulatory filing experience.
  • Significant management experience including outsourcing to Contract Research Organizations (CROs) and other clinical trial vendors.
  • Extensive experience managing Clinical Operations staff and optimizing resources across clinical studies.

Location: Newton, MA

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.

Project Manager: Clinical Development & Medical Affairs

Description

Project Manager will support the CMO and other physicians/scientists and personnel involved in clinical development and medical affairs (CD/MA) in a broad range of activities (not including direct clinical trial management), and will also support the Executive Director, Program Management.  Aware of the big-picture and priorities, works closely with other project managers and functions including regulatory affairs, business development, clinical operations, CMC.

Who are we looking for?

  • Innovative project manager who will help Allena’s Clinical Development & Medical Affairs teams in execution of their goals
  • Master’s degree or higher in the sciences is preferred; bachelor’s degree in the sciences considered if has extensive work experience in project management within the scientific/ pharmaceutical field.
  • Experience (5+ years) working as a project manager within a pharmaceutical/biotechnology company or within a consulting firm providing project management support to pharma, preferably in the medical/scientific arena.

What are we looking for?

  • Leading the way:  A creative and learning-agile project manager, willing to challenge the status quo
  • Ownership:  A partner to jointly own our company’s goals, execution and success
  • Working together:  A colleague to thrive on collaboration with our teammates
  • Loving what you do:  A team member with positive energy that is passionate about our mission

What are we offering?

  • Membership within a growing, CARING and collegial organization
  • Exposure to pioneering science of the therapies that utilize the GI tract to degrade metabolites
  • Unique opportunity to help develop the platform and strategy of an expanding company
  • Career support and leadership opportunities within the Clinical group

Responsibilities:  

  • Manages vendors and consultants relevant to the supported function (such as statistics, medical writing), including consulting agreements, contracts and related budgets and invoicing.  Specifically, responsible for managing the Duke Clinical Research Institute (DCRI) collaboration, and non-clinical trial research projects (such as OM-1 database research project); may support expanded access program. 
  • Manages selected meetings, including scheduling, preparing meeting minutes, timelines, tracking action items, driving deliverables; works with colleagues across projects and functions to understand and take into consideration cross-project overlap and existing resources within CD/MA to streamline their activities and deliverables. 
  • Identifies critical resource gaps and suggests and implements solutions and mitigation; will provide direct hands-on assistance as needed. 
  • Prepares or assists in the preparation of presentations to internal and external stakeholders and supports/manages the preparation of abstract/posters/manuscripts and other documents with internal reviewers and external contributors (e.g., external medical writing, authors); contributes content as appropriate, consolidates comments and resolves issues. 
  • Coordinates/assists with preparation for Advisory Board meetings, Allena presence at national and/or regional scientific meetings; includes supporting logistical management of vendors, investigators, Allena personnel at academic/scientific meetings and attending meetings
  • Gains and maintains knowledge of therapeutic area and current medical practice; helps with hands-on consolidation/organization of data to support medical functions and business development

Skills/Abilities:

  • Knows and implements Program and Project Management standards, including the use of templates, tools, and processes for effective planning and execution (e.g., MS Project)
  • Excellent written and oral communication skills

Competencies: PACE

Planning: Creates a comprehensive and realistic business plans by defining deliverables, milestones, accountabilities and measures of success to achieve objectives, while ensuring the optimal use of resources to meet efficiency, requests and due dates. Allocates appropriate amounts of time for completing own work. Prioritize critical and less critical activities. Proactively plans to avoid problems.

Adaptability: Responds resourcefully, flexibly and positively when faced with new challenges, transitions and demands. Willingly and effectively deals with the stress and complexities of various situations. Moves forward productively and optimistically under conditions of change and uncertainty. 

Collaboration: ls and promotes collaboration and works effectively with others across the organization to achieve goals. Demonstrates proficient cross company communication, cultural sensitivity, and partnership in interactions with others.  Involves others in decisions and plans and credits them for their contributions and accomplishments.

Execution: Drives execution of strategic and operating plans while maintaining operational effectiveness.  Conveys a strong sense of urgency around continuous improvement, achieving high quality results, and accelerating business performance.  Addresses problems directly and drives changes necessary to achieve business objectives.

Education and Experience:

  • Master’s degree or higher in the sciences is preferred; bachelor’s degree in the sciences considered if has extensive work experience in project management within the scientific/ pharmaceutical field.
  • Experience (5+ years) working as a project manager within a pharmaceutical/biotechnology company or within a consulting firm providing project management support to pharma, preferably in the medical/scientific arena.

Location: Newton, MA

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

Description

Clinical Project Manager is responsible for the planning, implementation, execution, and management of one or more clinical research studies. Manages clinical outsourcing to CROs and other vendors such as labs, IRBs, etc. May author, review, and approve various study-related documents and plans. Evaluates issues, interprets data, and suggests and implements solutions and mitigation as required. Responsible for the financial management of a vendors for the study, and develops and oversees study timelines.

Who are we looking for?

  • Innovative project manager who will help Allena’s Clinical Operations team in execution of their goals
  • Bachelor’s degree or nursing qualification is required. Scientific/health care field preferred. 
  • Experience (5+ years) working in relevant clinical research, preferably in clinical operations within a pharmaceutical company or CRO or similar organization.

What are we looking for?

  • Leading the way:  A creative and learning-agile project manager, willing to challenge the status quo
  • Ownership:  A partner to jointly own our company’s goals, execution and success
  • Working together:  A colleague to thrive on collaboration with our teammates
  • Loving what you do:  A team member with positive energy that is passionate about our mission

What are we offering?

  • Membership within a growing, CARING and collegial organization
  • Exposure to pioneering science of the therapies that utilize the GI tract to degrade metabolites
  • Unique opportunity to help develop the platform and strategy of an expanding company
  • Manager (Senior Director) who is a proven mentor and coach
  • Career support and leadership opportunities within the Clinical Operations group

Responsibilities:  

  • Leads global clinical trials and may be responsible for multiple trials simultaneously.
  • Represents and leads the study team to design, develop, execute, and deliver the clinical study following the clinical development plan/strategy and timelines.
  • Authors/reviews/ contributes to clinical study documents. Reviews and approves study-related plans generated by Clinical CROs and vendors. Ensures accuracy and information provided in clinical registration websites (www.clinicaltrials.gov)
  • Responsible for planning and conducting investigator’s meetings in cooperation with the respective departments.
  • Manages escalation of study related issues and communicates as appropriate with management and other functions. Evaluates CRO and vendor performance for future work
  • Trains and manages CRO and other clinical vendor activities to ensure the quality meets Allena and regulatory requirements.
  • Monitors the progress of clinical activity and produces regular and ad hoc reports and presentations as required (including budget, deliverables and timeline metrics).
  • Collaborates with the cross-functional teams on clinical activities (drug supply, resolution of data queries, etc.) and selection and management of clinical vendors
  • Maintains knowledge of therapeutic area, current medical practice and pharmaceutical regulations to ensure best practice across all activities.
  • May attend relevant symposia, conferences and scientific meetings, as necessary.
  • Provide support and potential identification of training needs across Clinical Operations and may support the creation, development, and potentially provide training support to meet those needs. This includes any lessons learned sharing across the project team members.

Skills/Abilities:

  • May perform periodic visits to sites and/or CROs to assess the progress of studies/protocol compliance. 
  • Up to 20% domestic and/or international travel may be required.

Competencies: PACE

Planning: Creates a comprehensive and realistic business plans by defining deliverables, milestones, accountabilities and measures of success to achieve objectives, while ensuring the optimal use of resources to meet efficiency, requests and due dates. Allocates appropriate amounts of time for completing own work. Prioritize critical and less critical activities. Proactively plans to avoid problems.

Adaptability: Responds resourcefully, flexibly and positively when faced with new challenges, transitions and demands. Willingly and effectively deals with the stress and complexities of various situations. Moves forward productively and optimistically under conditions of change and uncertainty. 

Collaboration: ls and promotes collaboration and works effectively with others across the organization to achieve goals. Demonstrates proficient cross company communication, cultural sensitivity, and partnership in interactions with others.  Involves others in decisions and plans and credits them for their contributions and accomplishments.

Execution: Drives execution of strategic and operating plans while maintaining operational effectiveness.  Conveys a strong sense of urgency around continuous improvement, achieving high quality results, and accelerating business performance.  Addresses problems directly and drives changes necessary to achieve business objectives.

Education and Experience:

  • Bachelor’s degree or nursing qualification is required. Scientific/health care field preferred. 
  • Experience (5+ years) working in relevant clinical research, preferably in clinical operations within a pharmaceutical company or CRO or similar organization.

Location: Newton, MA

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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