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.

Director of Financial Planning and Analysis

Reporting to the Chief Financial Officer, this position will establish and lead all Financial Planning and Analysis activities at our growing, Phase 3 biopharma company. This individual will be a key business-facing finance team member providing critical business and financial decision support to the organization. She/he will play an integral role in developing and leading processes such as budgeting and forecasting, management reporting, and control and reporting to support SOX requirements.

Responsibilities:

Develop annual operating plan and budget and long-term financial plan

  • Refine and manage Allena’s budgeting and forecasting processes to provide structure and ensure ownership to functional and program teams.
  • Partnering with functional and program management, develop integrated, detailed annual operating plan and budget for approval by the Board of Directors.
  • Own long-term forecast and financial models, including revenue projections and expense models, to guide strategic planning and provide context for external communications to investors, analysts, and potential partners.

Manage monthly and quarterly reporting process

  • Develop and implement financial reporting and management tools, including actual vs. budget variance analysis, rolling forecasts, and forward-looking P&L, balance sheet, and cash flow models for better understanding of the financials for internal operations, communication to the investment community, and support of business development initiatives.
  • Maintain and analyze capital structure.  Working with our external investor relations team, maintain and analyze shareholder list.

Serve as financial business partner to functional and program management

  • Develop and execute standard monthly financial packages and reviews with executive leadership and operating teams. 
  • Support functional and program management in monitoring actual vs budget and maintaining rolling forecasts. Identify in advance potential deviations from plan, surface issues and decisions for management discussions, and provide financial input and insight to programs and functions.
  • Represent finance at program team meetings and serve as a bridge between finance and other functions.

Perform targeted analyses to inform decision making

  • Provide timely decision support through value-added analysis, modeling and cross-functional collaboration to support business operations, strategic decisions, and key vendor and business development activities.
  • Maintain long-term forecast and financial model; understand implications of key decisions on long term financials and NPV.

Partner with Executive Director of Finance to develop and implement processes for control and reporting to support SOX requirements

  • Profile and analyze current processes; identify opportunities for improvement and implement process enhancements. 
  • Interface with external consultant and finance team to refine and implement monthly and quarterly compliance checklist.
  • Analyze, summarize and prepare reports for management and Audit Committee of the Board of Directors.

Requirements:

BA/BS in Accounting, Finance or Economics required; CPA a plus.

Excellent problem solving and analytical skills; advanced proficiency in Excel-based modeling.

Minimum of 8+ years of progressive, relevant experience in the biopharma or medical device industry required.

Experience in developing or maintaining SOX compliance processes or reporting a significant plus. Ability or experience mapping or analyzing processes and identifying opportunities for improvement preferred.

Strong verbal and written communication skills.  Promotes the 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.

Outstanding organizational skills and attention to detail.  Ability to manage multiple priorities in a fast paced, dynamic environment.

Conveys a strong sense of urgency around continuous improvement and achieving high quality results. Addresses problems directly and drives changes necessary to achieve business objectives.

Hands-on, highly motivated, results-oriented self-starter with a high level of personal accountability and integrity.  Establishes and maintains strong relationships internally and externally. Promotes 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.

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.

Vice President of Clinical Operations

We are seeking an exceptional Vice President of Clinical Operations to be a key member of the management team of our fast-growing, publicly-traded biopharmaceutical company in the pivotal stage of development of a first in class therapeutic to treat patients with enteric hyperoxaluria, a rare and severe disease leading to kidney stones and chronic kidney disease.  Reporting to the Executive Vice President of Research and Development, 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. 

Roles and responsibilities:

  • Primary strategic leadership role for overall clinical operations activity and execution of global clinical trials in alignment with Program Team goals
  • 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
  • Drive strategy and implementation for insourcing, outsourcing and management of strategic alliances with CROs and external partners
  • Design, develop and implement risk evaluation and mitigation strategy as it pertains to the conduct of clinical trials and key milestone deliverables
  • Drive innovation and efficiency in the execution of all clinical trials as well as selecting and adapting to the right clinical operating model
  • Lead the effort to strategically and tactically refine processes that govern all Clinical Operations and CRO activities, including vendor selection, operational systems, clinical quality and related SOPs (study planning, selection of study sites and investigators, tracking metrics, reporting and conduct of clinical trials)
  • Support the preparation and planning of study protocols, clinical study reports, as well as clinical operation components of submissions to regulatory authorities
  • Monitor and evaluate the effectiveness of department SOPs/processes and performance against key quality metrics
  • Partner and optimally interface with affiliated functions at Allena, including Clinical Development, Medical Affairs, Regulatory Affairs, Program Management, Finance, Technical Operations and Pre-clinical Development

Qualifications and Education Requirements:

  • 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

Preferred Skills:

  • 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

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.
 
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.
 
Collaboration: Embodies and promotes collaboration and working 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.
 
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.​

To learn more about Allena and apply for this position, please visit our website www.allenapharma.com

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