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This role will provide strategic, managerial and operational oversight of clinical trial operations for Decibel's lead asset, DB-OTO, in support of the OTOF gene therapy program. The Associate Director, Clinical Operations Lead will report to the Head of Clinical Operations and will work collaboratively and strategically with our cross-functional teams and outsourcing partners to ensure that all OTOF studies are conducted to the highest Good Clinical Practice (GCP) and quality standards, within agreed timelines and budgets.

What you will do:

• Oversee all aspects of clinical operations for assigned program, which includes at least two clinical studies. Contribute to the strategic and operational leadership relative to the direction, planning, execution, and interpretation of clinical program and the data collection activities
• Contribute to the development, management, and execution of the Clinical Development Plan (CDP) which includes timelines, budget, and operational resource requirements.
• Identify operational resources to support assigned development program including determination of program-specific outsourcing strategy for clinical trial operational matters in consultation with head of department & cross-functional partners
• Lead and/or assist in vendor identification through development and distribution of RFI/RFP and bid defense discussions in collaboration with cross-functional partners
• Assist in the development and implementation of the clinical program strategy and provide oversight of study execution in order to meet company goals and objectives
• Establish program and study milestones, and ensure accurate tracking and reporting of study metrics and timelines to senior leadership
• Drive timely preparation and review of clinical documentation including clinical protocols, program-level operational templates and manuals; participate in the development of the clinical components of regulatory submissions related to assigned program
• Liaise with CMC Ops/Supply Chain to assist and resolve issues regarding Investigational Medicinal Product and clinical trial supplies
• Lead program-level operational risk identification, management, and mitigation efforts and report progress to senior leadership
• Supervise development of contracts, including clinical trial agreements, work orders, service agreements and other relevant documents in partnership with appropriate functional areas. Assist with request, creation, and review of scope of work and budgets
• Manage assigned program budgets, provide ongoing financial reporting, and share projections with leadership and finance
• Establish relationships with vendors, advocacy partners, KOLs and clinical investigative sites; liaise with external partners as appropriate to ensure optimal Sponsor-site/vendor relationships
• Lead, plan, and execute program-level meetings, including governance and oversight meetings with vendors, consultants or investigator meetings
• Respond to and participate in Quality Assurance audits and/or regulatory authority inspections
• Accountable for overall performance of regulated clinical trials under assigned development program including inspection readiness; responsible to implement regular quality checks including results reporting to senior leadership
• Improve department-level and cross-functional initiatives, including Standard Operating Procedures (SOPs), processes, systems, tools
• Manage consultant staffing and resources; may manage clinical operations staff and performance, including hiring, training and coaching
• May represent clinical operations department through attendance at program-level meetings and discussions

What you will bring:

• Bachelors degree or equivalent in health/medical related area preferred
• 7+ years' clinical research or equivalent healthcare experience with progressive management experience managing trials and vendors (minimum 4 years of trial or program management)
• Experience in rare/orphan disease and/or gene therapy highly desirable
• Understanding of drug development and program management from pre-IND through regulatory filing
• Thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient. Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor
• Excellent interpersonal skills, ability to develop important relationships with internal and external partners
• Ability to identify issues, brainstorm solutions, and clearly escalate to key stakeholders to develop realistic plans and recommendations
• Extensive experience managing clinical programs, CROs, budgets, and timelines
• Strong knowledge of MS Project and developing Gantt charts / MS Excel
• Protocol and CSR writing experience
• Demonstrated excellence in complex project management
• Proven ability to solve problems with innovative solutions along with strong organizational skills. Excellent written and verbal communication skills are required.
• Experience in regulatory filings (e.g., NDA, BLA, MAA) desired
• Previous involvement in the oversight and management of GCP regulatory inspections desired
• Excellent knowledge of ICH-GCP
• Ability and willingness to travel up to 20% of the time, as needed (domestic and international)

The Document and Training Manager will manage the QA Document Control System,GxP Training Program and will support Decibel's non-GxP Document and Training management initiatives. This role will be responsible for developing procedures and training materials, providing training to Decibel personnel, and support the Electronic Quality Management System (eQMS) with primary responsibility for the Electronic Document Management System (EDMS) and Learning Management System (LMS).

What you will do:

• Manage the controlled document system ensuring that required documents are retrievable, accurate, complete and well organized
• Handle all supporting activities for implementation and maintenance of controlled documents including periodic review, training assignment management, retirement and archival
• Collaborate with cross-functional team to address documentation needs and alignment across existing procedures, as well as ensure training assignments are appropriately set for teams and individuals
• Develop, evaluate, and deliver high quality training programs across GxP functions and support external training by cross functional teams
• Define and track GxP department training metrics and report to Quality management on regular basis
• Maintain and implement improvements to the Document Control and GxP Training program to ensure compliance with GxPs
• Provide system administrative support for the eQMS with primary responsibility for the EDMS and LMS and support responsibilities for other Quality modules
• Support computer system assurance activities related to eQMS
• Support the QA department in meeting Quality Objectives and Regulatory Requirements
• Participate in inspection readiness and assist with internal and regulatory audits

What you will bring:

• Bachelor's Degree in related field and minimum 7 years' experience in Pharmaceutical Industry in a related function/role, or the equivalent combination of education, training and experience
• 3-5 years' experience using and supporting eQMS systems, specifically with EDMS and LMS
• Past experience in developing and delivering training material to cross-functional teams
• Experience with authoring SOPs and related controlled documentation
• Experience with computer system validation and management
• Understanding of global requirements of GXP
• Excellent interpersonal and decision-making skills working with a multi-disciplinary team, as well as verbal and written communication skills

Decibel Therapeutics is seeking a seasoned biopharma executive to lead the strategy and execution of the company's drug discovery and clinical development efforts. Reporting to the CEO, the EVP, R&D will be responsible for drug discovery, technology platform, preclinical translational research, clinical research and development, translational medicine, and development operations. The EVP, R&D will be a key member of Decibel executive management with leadership participation in all aspects of company strategy and operations, including extensive Board of Directors interactions.

The EVP, R&D will work with our R&D team to shape the product portfolio and oversee the advancement of those programs into and through clinical development. As a senior Decibel executive, the EVP, R&D will communicate and implement the company's scientific vision, strategic direction, and operating plans to both internal and external stakeholders.

The EVP, R&D will be an entrepreneurial and flexible thinker with experience in different pharmaceutical avenues, such that they can integrate our different disciplines and provide inspiring leadership to our outstanding research and clinical organizations. We are looking for a hands-on, participative leader, who will be instrumental in shaping the culture for the organization.

Success Criteria

The EVP, R&D will succeed over the coming five years by:

• Overseeing the successful advance of our vanguard gene therapy programs from research and through clinical development toward approval
• Building and shaping an outstanding research and clinical organization that advances our existing talent and augments them with hiring of other outstanding individuals to build the leading R&D organization in the industry focused on gene therapies for conditions of the inner ear.

Specific Responsibilities

• Partner with senior management and the Board of Directors to provide the long-range vision and strategy for Decibel
• Provide leadership on the R&D strategy for Decibel's current and future product portfolio
• Represent Decibel's portfolio both internally and externally to become recognized as a leading expert amongst key opinion leaders, clinicians and potential partners in hearing and balance. Establish and foster relationships with the international scientific and medical communities.
• Oversee all discovery, platform, preclinical and clinical research and development activities at Decibel
• Collaborate with Chief Development Officer to ensure Decibel meets its R&D milestones and to make strategic decisions re portfolio advancement
• Retain, attract, develop, lead, and inspire a world-class drug discovery and clinical research and development team
• Build and maintain the right organization, with a strong focus on the people – particularly their empowerment, development, and engagement
• Drive a culture consistent with Decibel Core Values with emphasis on transparent and open communication, collaboration, and the urgency to impact patients
• Actively participate in seeking product and/or technology alliances with appropriate pharmaceutical and biotech partners to enhance the development of the company's pipeline
• Actively participate in investor relations: engage and inspire investors and analysts with the life-changing potential of new medicines for the ear and Decibel's credibility to succeed

Professional Experience And Qualifications

• Extensive background in drug discovery, clinical drug development, translational medicine, or related discipline, with 20+ years of experience successfully managing global drug discovery programs into and through the clinic
• Ideally MD/PhD or MD with significant research background
• Background in genetic and rare diseases and development of genomic medicines essential. Experience in diseases of the nervous system or regenerative medicines would be beneficial.
• Demonstrated success and creative approaches in innovative fields of drug development, including drug modality or novel targets or new clinical field of drug development
• A proven track record as a developer and mentor of key talent
• Demonstrated success leading within an entrepreneurial, innovative, and rapidly changing environment
• Proven track record of fostering creativity, productivity, execution with a sense of urgency, teamwork, accountability, cross-functional collaboration
• Strong external presence with excellent communication skills and experience in business development and investor settings.
• Demonstrated experience in participation in cross-functional management teams with ability to integrate scientific data and strategy with business and financial information to shape optimal business strategy

Leadership Competencies

• Drives Vision and Purpose: Serves as a strong champion for the organization's vision and mission; regularly energizes people to commit to this long-term direction
• Leads with reference to Decibel's Core Values, promoting aspirational goals and behaviors and an environment that celebrates diversity of thought and background
• Entrepreneurial: Celebrates the need to integrate changing data and circumstances and to adapt accordingly while holding tight to core values and mission
• Decision Quality and Speed: Sets the expectation that decisions are made rapidly and efficiently and are supported by robust data and sound logic
• Develops Talent: Creates a learning culture; coaches team members actively; energizes colleagues about their own development
• Drives Engagement: Regularly takes opportunities to celebrate efforts and progress
• Builds Effective Teams: Brings rich experience in the establishment of strong teams with the right mix of abilities and perspectives and a wide array of complementary strengths
• Cultivates Innovation: Inspires people to develop breakthrough solutions
• Ensures Accountability: Holds self and team accountable for outcomes; fosters an environment in which the team holds each other accountable for delivering on goals

We are seeking an energetic and strategic Senior Director, Commercial Development to lead the planning, implementation, and management of commercial strategy for our lead gene therapy program during clinical development.

What you will do:

• Develop and implement the Commercial Development Strategy for lead gene therapy program
• Responsible for developing commercial strategy and managing operational plans including evolution of target product profile of lead gene therapy product to drive successful commercialization
• Establish commercialization and market-building capabilities for audiology gene therapy market
• Core Member of Product Team who collaborates closely with Clinical Strategy, Medical Affairs, Patient Advocacy, Program Management, and Finance functions
• Lead commercial development sub-team and manage the overall commercial strategy for product through clinical development phases to build foundation for successful launch
• Develop insights based on analysis of unmet needs, market research, market access/pricing/value creation, and understanding of stakeholders
• Energetic leader with both strategic and operational expertise and thrives in a highly collaborative, small biotech environment

Gene Therapy Product Team

• Lead Commercial Development initiatives for gene therapy program during clinical trial milestones
• Develop initial product positioning and differentiation, and define and manage commercialization strategic imperatives and tactics
• Lead market research with physicians (with Clinical), patients (with Patient Advocacy Group), and payers to inform program advancement and key decisions
• Collaborate with FP&A to develop, assess, and update commercial forecasts and sensitivity analysis
• Drive early reimbursement strategy and develop initial value story
• Identification of market-building activities required for adoption post-approval across geographies
• Partner with clinical team on genetic testing initiatives
• Partner with patient advocacy, medical affairs and corporate communication functions on messaging, education, and disease awareness initiatives

What you will bring:

• 10-15 years of life science industry experience in commercial roles
• BS/BA required; MBA strongly preferred
• Experience in rare diseases and/or genetic medicines and gene therapy preferred
• Launch experience an advantage
• Market access and payer experience an advantage
• Strong analytical and strategic thinking approach
• Strong communication skills with ability to influence key strategic discussions
• Demonstrated ability to successfully collaborate with R&D organization
• Understanding of US and European marketing and payer environments an advantage

• Create a vision for clinical data analytics and champion our data governance & clinical data ecosystems by collaborating with partner functions, including IT, Quality, and Regulatory
• Lead clinical data workflow for global development programs; be accountable for overall clinical data performance of regulated clinical trials including inspection readiness; implement regular quality checks including results reporting to senior leadership. Contribute to improvement of department-level and cross-functional Standard Operating Procedures (SOPs), processes, systems, tools
• Create and execute a resourcing strategy to support multiple development program objectives, including developing, forecasting, and leading budget
• Lead as an SME alongside your team of expert data managers, statisticians, programmers, and data visualizers, and represent and advocate for function in multidisciplinary project team meetings and leadership team meetings
• Establish standards for documentation including electronic case report forms, case report form completion guidelines, data transfer/handling agreements, and statistical programming; lead efforts to drive adoption of external innovations related to clinical data to accelerate drug development, optimize risk-based quality management and enhance analytic capabilities
• Oversee clinical data transfers to support program advisory committees, adjudication committees, data monitoring committees and/or external audiences; ensure all clinical data is collected, handled, transferred, stored, ensuring compliance with GDPR standards and local privacy requirement standards, and identify systems or processes to fulfill requirements
• Serve as a member of Study Teams; oversee and/or drive preparation and review of clinical data-related documentation including protocols, data management plans, CRFs, SAPs, data review plans, and CSRs
• Participate in developing clinical components of regulatory submissions and the transfer of clinical data as needed, and ensure data deliverables meet regulatory submission requirements
• Ensure all clinical data is collected, handled, transferred, stored, ensuring compliance with GDPR standards and local privacy requirement standards, and identify systems or processes to fulfill requirements
• Oversee clinical data transfers to support program advisory committees, adjudication committees, data monitoring committees and/or external audiences
• Help design listings and visualizations in support of clinical and medical review of data
• Solve operational obstacles for studies based on metrics data, audit reports, and input from project team members and stakeholders
• Coordinate with safety vendor on adverse event reconciliation
• Lead portfolio-level risk identification, management, and mitigation efforts and report progress to senior leadership
• Respond to and participate in Quality Assurance audits and/or regulatory authority inspections

• Bachelor's degree or equivalent experience in health-science related field
• 12+ years of experience in roles involving clinical data in the pharmaceutical/biotechnology industry; 5+ years of leading cross-functional teams, with demonstrated ability to recruit and develop talent; experience in startup organization desired
• Demonstrated experience serving as a key leader to support organizational decision making and strategic planning, with experience working in multi-functional, team-oriented environments
• Expertise in clinical data collection, cleaning and analysis; ability to demonstrate strategic insight and operational excellence
• Expert understanding of ICH and regulatory environment as it pertains to data deliverables
• Expert knowledge of EDC systems (Rave preferred)
• Understanding how data decisions impact other functional areas and deliverables
• Understanding of drug development and program management from pre-IND through regulatory filing is essential
• Previous involvement in the oversight and management of GCP regulatory inspections and experience in regulatory filings preferred
• Experience designing and standardizing data collection, transfer and storage protocols
• Thorough understanding of CDISC, SDTM standards
• Demonstrated excellence in complex project management and effective management of multiple projects/priorities

• Help define and restructure/reorganize filing systems.
• Assist with management of our legal files, archives, and contract management system.
• Assist with contractual document review and template management.
• Partner with the Decibel lawyer to assist in drafting and negotiating contracts.
• Provide administrative support to legal team.

• Undergraduate planning to pursue a Juris Doctorate or paralegal/legal service career in a co-op program at an accredited US based university.
• Preferred Field of Study: Legal Studies, Political Science, Government Studies, Philosophy, Civics, other fields of study are still encouraged to apply.
• Interest in biotech business and in-house legal functions.
• Interest in risk management and compliance functions.
• Proficiency with Outlook, Word, Excel, Powerpoint, Teams.

• Provide administrative support and assist the Clinical Operations team in the preparation of agendas, minutes and tracking of action items, risks, timeline maintenance for team meetings
• Support to all aspects of study progress (from planning to close-out), to assure adherence to intended timelines and achievement of study goals, while ensuring quality in accordance with FDA, EMEA, GCP, and ICH guidelines
• Assist with assigned aspects of clinical trials. This includes various types of tracking and oversight of deliverables
• Assist with creation of study-level communication to internal and external parties as directed
• Assist in monitoring the completeness and timeliness of trial-specific document submission to the Trial Master File and Investigator Site File
• Assist with the review of case report forms, database setup (e.g., EDC, IRT or other databases containing clinical data) and user testing
• Support Investigator recruitment feasibility and collection of essential documents
• Assist the project team in preparation and submission of documentation packages to Ethics and/or Biosafety Committees
• Collaborate with appropriate functional areas to forecast Investigational Medicinal Product and clinical trial supply needs, including tracking of requests and resolution of issues
• Assist in the planning and execution of trial-level meetings, including meetings with vendors or consultants, investigator meetings
• Provide support for regulatory inspections or audits
• Help to identify and resolve study-level administrative issues

• Must be currently enrolled as a full-time student in a Bachelor's/Masters/MBA/PhD co-op program at an accredited US based university or college in health/medical related area
• Excellent written and verbal communication skills and attention to detail are required
• Ability to function at a high level in a team setting whether working in a group or acting as an individual contributor
• Proficiency with MS Office Suite
• Ability to identify issues and seek solutions

• Maintain and follow animal laboratory protocols, including accurate record keeping
• Interact with various project teams to share and distribute information
• Work as part of a team, regularly collaborating with in vivo and histology scientists to manage, coordinate, and schedule studies
  • Conducting high throughput ABR and DPOAE recordings in anesthetized rodents
  • Organize and analyze electrophysiology evoked potential data
  • Communicate results to project teams and identify next steps

• BS and/or MS in biomedical engineering, biological sciences or related discipline; MS in biomedical engineering or neuroscience preferred
• Lab experience in an academic or industrial setting
• Self-motivation and an ability to work independently, with outstanding teamwork focus
• Experience with in vivo studies animal models, including handling, anesthesia and IP dosing strongly preferred
• Strong organizational skills and excellent written and oral communication skills
• Familiarity with neurophysiology (EEG or evoked potential recordings) and/or background in acoustic experiments
• Familiarity with Python or other programming tools for data acquisition and analysis preferred