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/Senior Director, GCP Quality Assurance

JOB DESCRIPTION:

The Director/Senior Director, GCP Quality Assurance oversees GCP activities at Allena, our CROs and Investigator Sites, leads related vendor and site audits, and implements internal quality systems/processes for ongoing compliance and Inspection Readiness. The successful hire will ensure high quality execution of clinical trials from first in human through commercial marketing authorization and post-marketing clinical trials. This person will manage cross functional relationships with internal and external stakeholders and be the Lead Quality Assurance representative to clinical teams. This individual will be hands on with internal and external partners. This is a high visibility position with great impact potential.

RESPONSIBILITIES:

  • Proactively provide GCP QA support to global clinical development activities to protect patient safety, maintain data integrity, and support operational efficiency
  • Work dynamically and proactively with other Quality Assurance and Functional Area leads to facilitate development of GXP-compliant procedures to support conduct of clinical studies and prepare the company to successfully commercialize pharmaceutical products
  • Assist with the organization, planning, preparation, coordination, and documentation of regulatory inspections, including QA oversight and auditing of eTMF.
  • Lead, and/or conduct, global Good Clinical Practice (GCP) Audits of systems and processes related to clinical drug development and operations.  As a preference, the Director role may include Good Laboratory Practice (GLP) audits related to pre-clinical studies.
  • Lead, and/or conduct/support (in collaboration with GMP QA colleagues), global Good Pharmacovigilance Practice (GVP) Audits of systems and processes related to clinical and post-market patient safety information collection, evaluation and reporting
  • Select and manage contractors who provide contract audit services
  • Lead quality investigations, including generation and follow-up of Corrective and Preventative Action (CAPA) plans
  • Lead GCP related refinements and improvements to the Quality System of controlled procedures (Policies, SOPs, Work Instructions, etc.) As a preference, the Director role may include GLP Quality System improvements.
  • Provide GCP compliance oversight of internal systems and processes as well as those of CROs, Vendors, and Clinical Investigator Sites (via vendor selection, vendor audits, site audits and execution of integrated clinical quality management plans)
  • Review and provide input to clinical documentation (e.g. protocols, study reports, IBs, ICFs, etc.)
  • Develop and measure quality metrics to drive consistent standards throughout the organization
  • Create key quality metrics for tracking and trending data related to GCP activities, report metrics and significant quality incidents to QA management.
  • Conduct and coordinate GCP compliance training to internal and external customers (as required).
  • Lead inspection readiness preparations (internal and external) including hosting and interacting with regulatory agencies during inspections on GCP related matters.

REQUIREMENTS:

  • Bachelor's degree required with 10+ years relevant experience in Pharmaceutical or Biotechnology and/or Medical Device Quality Assurance (in sponsor companies, CROs, or GCP consulting), with at least 5+ years (for Director) and 10+ years (for Senior Director) global GCP specific experience.
  • Demonstrated ability to effectively communicate and influence the outcomes of the decision-making process, conveying an appropriate sense of urgency.
  • Analytically strong, with great attention to detail.
  • Practical knowledge and experience identifying key performance metrics for quality indicators, setting targets to maintain a state of control while identifying areas for improvement.
  • Extensive experience auditing clinical CRO's, vendors, and clinical sites.
  • Preferred related experience in GLP and/or GVP quality assurance for the Senior Director position.

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.

Head of Legal and Administrative Affairs

JOB DESCRIPTION:

We are seeking an in-house counsel to be a key member of the executive team of our fast-growing, publicly-traded biopharmaceutical company. Reporting to the CEO, you will be responsible for all legal functions, including IP strategy and execution, healthcare compliance, corporate disclosure and compliance, commercial contracts, and employment matters. You will also be involved in business development and financing activities, represent and address legal matters with our Board of Directors, serve as Corporate Secretary, and draw on and manage our external legal team of corporate, IP, regulatory and employment law partners. You will also collaborate closely with other functional heads. Finally, this role will also manage Allena’s administrative, IT and facilities functions as staffed by internal and external resources.

Responsibilities:

  • Defines, architects and implements Allena’s IP strategy with respect to internal R&D pipeline, partners, competitors and suppliers. Working with outside IP counsel, conduct IP due diligence to support business partnerships and licensing, including design of IP framework and analysis of patentability, validity and freedom-to-operate.  
  • Provides legal support for financing activities and diligence associated with financing or other transactions
  • Reviews, drafts and, in collaboration with functional, program, and financial partners, negotiates industry agreements, including business development and license agreements, manufacturing and supply agreements, research and clinical trial agreements, consulting and service agreements and confidentiality agreements.
  • Oversees the company’s compliance programs.  Responsible for developing and maintaining appropriate policies, procedures and training programs across various functional areas.
  • Reviews employment agreements and employment-related documents and assists HR team with employment legal matters as needed.
  • Serves as Corporate Secretary for Board related activities
  • Plays key role in strategy, drafting and execution of Corporate Disclosures for Annual, Quarterly and ad-hoc SEC filings.
  • Coordinates activities and legal advice from outside legal counsel as required, including regulatory counsel.
  • Is responsible for key corporate support functions, including administrative, IT and facilities. Manages administrative team and IT consultants; evaluates appropriate staffing and internal/external mix of resources as company grows

Requirements:

  • JD degree with 12+ years of general corporate legal experience in biotechnology, either in-house, private practice or both.
  • Emerging growth and public company experience highly preferred.
  • Demonstrated facility with and knowledge of key corporate biotechnology operational functions, including their interface with legal affairs

Competencies Needed:

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.

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: 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.

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 Vice President of Research and Development

JOB DESCRIPTION: 

Reporting to the President and Chief Operating Officer, The Executive Vice President of Research and Development will be responsible for developing and implementing Allena’s R&D strategy in pursuit of the company’s goal of securing regulatory approval and enabling successful commercialization of Allena’s novel compounds that will benefit patients with rare and severe metabolic and kidney disorders. Specifically, the Executive Vice President of Research and Development will be responsible for leading all aspects of scientific research and clinical development including preclinical research, pharmacology, toxicology, regulatory affairs, clinical operations, clinical research, biostatistics, pharmacokinetics, medical writing, medical affairs ,and pharmacovigilance/drug safety. 

This individual will supplement Allena’s existing resources to hire, establish, and operate an exemplary biopharmaceutical R&D organization; will serve as a key member of Allena’s executive leadership team; and will actively participate in strategic planning and direction setting for Allena and the development of its technology. In summary, the Executive Vice President of Research and Development is expected to play a critical leadership role for Allena and its scientific and clinical programs. 

RESPONSIBILITIES: 

  • Provide scientific leadership and clinical oversight to the research, development and regulatory functions at Allena. Manage the overall development for drug candidates including preclinical research, IND enabling studies, clinical proof of concept studies, pivotal studies and regulatory submissions. 
  • Recruit and manage a top performing clinical development, medical affairs and drug safety organization. 
  • Recruit and manage a top performing pre-clinical research team including pharmacology, toxicology, in vitro bench research and in vivo animal research. 
  • Chair Allena’s R&D Steering Committee, which is the multidisciplinary decision making forum for advancement and optimization of the company’s drug candidates. 
  • Represent Allena and its programs with US and international regulatory agencies. 
  • Oversee competitive intelligence, as well as scientific and clinical knowledge management to track advances in relevant therapeutic areas, by interacting with external experts, attending scientific meetings and staying abreast of the literature. 
  • Convey information and present updates for the company’s clinical programs to key stakeholders including Allena’s Board of Directors, KOLs, regulatory agencies, shareholders, CROs, business partners, and patient advocacy organizations. 
  • Ensure that, if successful, Allena’s clinical program are designed and executed to position the company and its drug candidates for patient benefit and ultimate commercial adoption. 
  • Represent Allena both internally and externally with the scientific and business communities including via scientific publications, conference presentations, and investor meetings. 
  • Lead the process of R&D goal setting, including the establishment of and adherence to timelines and budgets. 
  • Participate in Business Development activities including with respect to out licensing of Allena’s assets and in licensing of external assets. 
  • Help to establish and maintain collaborations with partners in academia, government and industry and with patient advocacy groups and patients as appropriate to accelerate approval of medicines for patients with rare and severe metabolic and kidney disorders. 
  • Further Allena’s culture of scientific excellence, achievement and compliance for the benefit of the company’s stakeholders including patients, employees, regulatory agencies, clinicians, and investors. 

REQUIREMENTS: 

  • MD or MD/PhD with demonstrated biopharmaceutical industry experience in leading research organizations, as well as clinical development of early, mid, and late stage therapeutic programs. A record of achievement should include designing, planning, and executing clinical studies leading to the successful regulatory approval and launch of novel therapetuics. 
  • Experience in Nephrology, Urology and/or rare diseases is desired. Expertise in adjacent therapeutic areas including Gastroenterology, Rheumatology and Endocrinology would also be beneficial. Knowledge and experience running Phase 3 Studies and completing a successful regulatory application is necessary, especially a Biologics Licensing Application (BLA). 
  • Credibility within the medical and scientific community is essential. Strong personal and professional relationships with key opinion leaders in the Urology and Nephrology field is desired. 
  • Proven track record of exceptional communication skills with ability to relate to both internal and external stakeholders, and to develop strong positive relationship with internal colleagues and external advisors. 
  • Experience in developing successful collaborations with academic and business partners. 
  • Strong leadership and management skill shown by track record of building and leading exemplary research, clinical, regulatory and medical affairs teams. 
  • Ability to operate effectively within a publicly-traded, entrepreneurial and science-driven company 
  • Highly-motivated, assertive, able to inspire others, and hands-on with excellent judgment and adherent to the highest ethical standards. 
  • Superior analytical insight with an ability to consider multiple options, establish priorities and apply resources effectively based on effective decision making. 
  • Excellent financial, operational, and program management capabilities. 
  • Understands and demonstrates the skills and poise necessary to build and grow a successful biopharmaceutical company. 

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

Under the supervision of Senior Director, Quality Control & Stability, will coordinate 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.  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.  This role works across multiple departments, including Quality Assurance, Analytical Development, Supply Chain, Manufacturing, and Regulatory.  Specific duties include:

  • Support all QC functions related to GXP activities including authoring standard operating procedures (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;
  • Write new SOPs, protocols, reports, deviations and memos;
  • Play a key role 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;
  • Troubleshoot issues, work in a team environment, and work across multiple departments; and
  • Approx. 20% of time will be spent travelling nationally and internationally to contract manufacturing sites and testing labs.

Minimum Requirements:

Bachelor’s degree in Chemistry, Pharmacy, Biomedical Sciences, or related field, or foreign degree equivalent, followed by 5 years of pharma/biotech quality control (QC) experience.  The experience (which may be gained concurrently) must also include:

  • 5 years of quality control experience in a GMP laboratory setting including managing method transfers and validations per ICH requirements;
  • 5 years of experience in chemical analysis methodologies common for biologics analysis including each of the following:  HPLC, Enzyme activity, SDS-PAGE, ELISA, wet chemistry and compendial testing;
  • 4 years of experience managing external QC projects at CMO (Commercial Manufacturing Organizations) or CTL (Contract Testing Labs);
  • 2 years of experience as part of QC role working with internal Regulatory groups authoring responses to questions from regulatory filings;
  • Previous face-to-face interactions with FDA and/or other regulatory bodies as a key contributor during regulatory inspections;
  • Experience preparing a Quality Control group for at least one successful Pre-Approval Inspection.

Job Location: Newton, MA.

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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