Location
Watertown, MA | United States
Job description
Position Summary:
Reporting to Enanta’s Chief Medical Officer, the Executive Director/Vice President, Biometrics will lead the biostatistics and statistical programming functions for Enanta’s rapidly expanding clinical portfolio of promising therapeutics in Infectious Disease and Inflammation. In this position, you will play a key role in the strategy, development, and execution of the clinical pipeline. With a strong technical, regulatory and scientific foundation, this role will work closely with drug development teams to define the most effective approach across Enanta’s clinical pipeline.
The Vice President, Biometrics will be involved with all statistical facets of the clinical programs, including Phase 1-3 trials progressing to NDAs and responsible for corresponding sections in regulatory documents (e,g. IND submission, IND annual updates, briefing documents, study protocols, investigator brochures and other study-relevant documents like patient informed consent documents)
This role will work across a matrixed organization with Non-clinical, Clinical Operations, Regulatory, and Clinical Development teams to ensure fully harmonized and integrated development strategies.
Primary Responsibilities: - Act as the strategic leader providing a strong, clear statistical voice for Enanta’s clinical programs in conjunction with Clinical Development, Clinical Pharmacology, Clinical Operations and Regulatory.
- Provide leadership and mentorship to team members
- Provide specific functional expertise to enhance innovation and efficiency in Enanta’s drug development programs
- Lead statistical efforts to secure regulatory approvals.
- Statistical review and oversight of clinical trial data and external vendors.
- Collaborate closely with Regulatory, Clinical Operations, Clinical Pharmacology, and Clinical Development to ensure tight strategic integration of product development plans and strategies.
- Be accountable to relevant timelines and deliverables associated to Clinical Research and Operations Plans.
- Drive biostatistical facets of all major written deliverables (regulatory submissions, original articles, abstracts) and presentation materials.
- Be responsible for final review and sign off with respect to all controlled documents.
- Influence internal and external audiences in a high impact, highly visible fashion.
Qualifications: - PhD Degree in Statistics, Mathematics, or related fields
- 13+ years industry experience
- 5+ years of experience demonstrating successful leadership experience including project and people management
- Early stage development and regulatory experience preferable.
- Exposure to and management of significant accelerations and challenges in clinical programs.
- Ability to work with the Senior Executive Team and other external audiences
- Ability to thrive in highly entrepreneurial biotech environment, with some prior experience in a small/medium size company an advantage.
- Excellent interpersonal skills and the ability to function in a highly matrixed team environment are essential.
- Excellent presentation and writing skills
How to Apply Please complete the application below and include the following attachments:
- Cover Letter
- CV / Resume
- Research Summary (if applicable)
About Enanta Enanta is using its robust, chemistry-driven approach and drug discovery capabilities to become a leader in the discovery and development of small molecule drugs with an emphasis on indications in virology and immunology. Enanta’s research and development programs are currently focused on respiratory syncytial virus (RSV) and chronic spontaneous urticaria (CSU) and the company has previously advanced clinical-stage compounds for SARS-CoV-2 (COVID-19) and chronic hepatitis B virus (HBV) infection.
Glecaprevir, a protease inhibitor discovered by Enanta, is part of one of the leading treatment regimens for curing chronic hepatitis c virus (HCV) infection and is sold by AbbVie in numerous countries under the tradenames MAVYRET® (U.S.) and MAVIRET® (ex-U.S.) (glecaprevir/pibrentasvir). A portion of Enanta’s royalties from HCV products developed under its collaboration with AbbVie contribute ongoing funding to Enanta’s operations. Please visit for more information.
E n anta Pharmaceuticals is an equal opportunity employer (EOE) with a commitment to diversity. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, religious creed, gender, gender identity, sexual orientation, physical or mental disability, protected veteran status, or any other class protected by law.
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