Vice President, Biometrics (Consultant)

Reporting to the Chief Medical Officer, this individual will serve as an integral team member with exposure to multiple facets of business operations. The Vice President, Biometrics (Consultant), will be accountable for ensuring that clinical evidence generation, data quality, statistical strategy, submission readiness, and biometrics operations are aligned with Company strategy, portfolio priorities, regulatory requirements, and capital-efficient execution. The Vice President, Biometrics (Consultant) will serve as the Company’s senior biometrics representative to global health authorities, partners, key opinion leaders, and other stakeholders.

Elicio Therapeutics (ELTX) is a growing organization based out of the Seaport area of Boston, Massachusetts with additional staff functioning in a virtual based environment from the Greater Boston area and throughout the United States.

Major Duties/Responsibilities

The Vice President, Biometrics (Consultant), is responsible for all aspects of biostatistics and the statistical programming functions of the Company, provide strategic input to the clinical development plans, and ensuring the corporate objectives are met with high quality to enable regulatory filings. Major duties and responsibilities also include:

• Oversees the planning and execution of biostatistics, and statistical programing activities in support of clinical development plans, clinical trials, regulatory approval, and marketing goals aligned to corporate goals.
• Builds, leads and manages an effective biostatistics team including the development of standard department operating processes, and mentors junior staff.
• Provides strategic and technical leadership and supervision to a multidisciplinary team and responsible for the design, development, and/or implementation of innovative statistical methods, data and programming operations.
• Responsible for the overall quality of all biostatistics, statistical programming, and all relevant deliverables.
• Provides input to cross functional teams in making the best decisions and capable to articulate complex statistical concepts into lay language; makes timely and calculated decisions to change the course of action when necessary.
• Lead the selection of CROs (external vendors) for outsourced biometrics activities; accountable for costs, timeliness, and quality of the deliverables.
• Utilize the experience with the regulatory submission process and represents the company at meetings with global regulatory health authorities, including extensive engagement in the discussions with and present company’s positions at meetings with FDA, EMA and/or other regulatory agencies.
• Apply the comprehensive understanding of the oncology disease landscape of interests which includes but not limited to trial designs, competitions, operational understanding of HEOR and reimbursement requirements.
• Advise and support publication strategy, scientific presentations, and the assessment of translational laboratory data.
• May engage in strategic discussions with senior management, advisory boards, and key opinion leaders on topics relevant to the product candidates.
• Promote a culture of collaboration, cooperation, cross functional inclusion, execution excellence, effective communication and cross-functional problem-solving to become a high-performing team.
• Partner with Clinical Development and Regulatory Affairs to shape integrated global development plans, including target product profiles, indication strategy, endpoint selection, control-arm strategy, estimands, statistical assumptions, and confirmatory evidence plans.
• Provide independent, data-driven recommendations on portfolio prioritization, clinical program advancement, indication expansion, go/no-go decisions, protocol amendments, and risk-mitigation strategies.
• Establish biometrics governance forums and decision-making processes to ensure timely escalation and resolution of critical risks related to data integrity, statistical validity, database readiness, endpoint reliability, and submission readiness.
• Define departmental performance metrics and regularly report on quality, delivery, budget, resource utilization, regulatory readiness, and key program risks to executive leadership.

Education & Professional Experience

Required:

• MS or PhD in statistics, biostatistics or related field with a minimum of 15 years of experience in Pharma and/or Biotech.
• Extensive clinical trial experience including randomized time to event data, and a minimum of 10 years in leadership roles.
• Excellent communication, written, and interpersonal skills; demonstrated strong leadership skills and ability to solve complex issues and collaborate effectively with cross-functional teams.
• Strong team player with the ability to work in a fast-paced environment, manage competing priorities, while filling gaps as needed.
• Recent experience in oncology; pancreatic cancer experience
• Experience working in small pharmaceutical/biotech companies
• Familiar with ICH guidelines, FDA, EMA, and requirements of global regulators.
• NDA/BLA experience including eCTD submissions in oncology
  

Working Conditions: Busy home office/office/laboratory environment with frequent deadlines and interruptions.

Travel: Travel may be required to the Company’s headquarters a few times per year, if necessary.

Physical Requirements: Subject to periods of sitting or standing, vision is required to monitor data.

Work Location: This role can be remote (employees near Boston are welcome to come onsite, though it is not a regular requirement).

Work Status: This role is a 1099 Independent Contractor role to start.

Compensation Range: Hourly bill rate of $225.00 - $325.00.

About Elicio Therapeutics

Elicio Therapeutics, Inc. (Nasdaq: ELTX) is a clinical-stage biotechnology company advancing next-generation immunotherapies for the treatment of KRAS-driven cancers, including mKRAS-positive pancreatic and colorectal cancers. Elicio intends to build on recent clinical findings in the personalized cancer immunotherapy space to develop effective, off-the-shelf immunotherapies. Elicio’s AMP technology aims to enhance the education, activation and amplification of cancer-specific T cells relative to conventional immunotherapy strategies, with the goal of promoting durable cancer immunosurveillance in patients. Elicio’s ELI-002 7P lead program is an off-the-shelf immunotherapy candidate targeting the most common KRAS mutations, which drive approximately 25% of all solid tumors. Off-the-shelf immunotherapy approaches have the potential benefits of low cost, rapid commercial scale manufacturing, and rapid availability of drug to patients, especially in neo-adjuvant settings and for prophylaxis in high-risk patients, contrary to personalized immunotherapy approaches. Elicio’s pipeline includes additional off-the-shelf therapeutic cancer immunotherapy candidates, including ELI-007 and ELI-008, that target BRAF-driven cancers and p53 hotspot mutations, respectively. For more information, please visit www.elicio.com.

About the Amphiphile Platform

Elicio’s proprietary AMP platform delivers investigational immunotherapeutics directly to the “brain center” of the immune system – the lymph nodes. Elicio believes this site-specific delivery of disease-specific antigens, adjuvants and other immunomodulators may efficiently educate, activate and amplify critical immune cells, potentially resulting in induction and persistence of potent adaptive immunity required to treat many diseases. In pre-clinical models, Elicio observed lymph node-specific engagement driving therapeutic immune responses of increased magnitude, function and durability. Elicio believes its AMP lymph node-targeted approach will produce superior clinical benefits compared to immunotherapies that do not engage the lymph nodes based on preclinical studies. Elicio’s AMP platform, originally developed at the Massachusetts Institute of Technology, has broad potential in the cancer space to advance a number of development initiatives through internal activities, in-licensing arrangements or development collaborations and partnerships. The AMP platform has been shown to deliver immunotherapeutics directly to the lymph nodes by latching on to the protein albumin, found in the local injection site, as it travels to lymphatic tissue.