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Vice President, Biometrics and Clinical Analytics

Aditum Bio ¡ Hybrid from Oakland, California or Cambridge, Massachusetts
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2d ago
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Hybrid from Oakland, California or Cambridge, Massachusetts
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<section id="comp-l76soz3j1" class="_3d64y"> <div class="_1uldx" data-testid="columns"> <div id="comp-l76soz3l1" class="_1vNJf"> <div class="" data-mesh-id="comp-l76soz3l1inlineContent" data-testid="inline-content"> <div data-mesh-id="comp-l76soz3l1inlineContent-gridContainer" data-testid="mesh-container-content"> <div id="comp-l76soz452" class="_2Hij5 _3bcaz" data-testid="richTextElement"> <p>&nbsp;</p> <p><strong>Company&nbsp;Overview</strong></p> <p>At Aditum Bio, our mission is to rapidly translate scientific discoveries into new medicines. Co-founded by industry veterans Joe Jimenez, former CEO of Novartis and Mark Fishman, former President of the Novartis Institutes for Biomedical Research, the firm in-licenses promising therapies that for some reason are not advancing toward the clinic. The firm focuses on the translational phase of medicine to generate data that can support full clinical development, and eventual market launch, to reach patients in need.&nbsp;</p> <p>&nbsp;</p> <p><strong>Position Summary</strong></p> <p>The VP of Biometrics and Clinical Analytics will provide hands-on leadership across the biometrics function—biostatistics, statistical and clinical programming, data management, clinical analytics, safety, and systems—supporting first-in-human, dose-escalation, proof-of-concept, and biomarker-driven studies. The role partners with clinical development, operations, translational science, regulatory, quality, and executive leadership to design rigorous, capital-efficient studies and deliver near-real-time visibility into clinical and operational data</p> <p>This&nbsp;high-impact,&nbsp;portfolio-level&nbsp;role&nbsp;suits&nbsp;a&nbsp;senior&nbsp;biometrics&nbsp;and&nbsp;analytics&nbsp;leader&nbsp;who&nbsp;thrives&nbsp;in&nbsp;early-stage&nbsp;environments,&nbsp;shapes&nbsp;programs&nbsp;at&nbsp;critical&nbsp;inflection&nbsp;points,&nbsp;and&nbsp;owns&nbsp;the&nbsp;biometrics&nbsp;sourcing&nbsp;strategy&nbsp;across&nbsp;CROs,&nbsp;consultants,&nbsp;and&nbsp;vendors.&nbsp;This&nbsp;person&nbsp;may&nbsp;serve&nbsp;as&nbsp;study&nbsp;statistician&nbsp;or&nbsp;oversee&nbsp;consultants&nbsp;and&nbsp;future&nbsp;FTEs,&nbsp;while&nbsp;remaining&nbsp;a&nbsp;hands-on&nbsp;resource&nbsp;for&nbsp;core&nbsp;analyses&nbsp;across&nbsp;teams.</p> <p>&nbsp;</p> <p><strong>Position&nbsp;Responsibilities</strong></p> <ul> <li><strong>Strategic&nbsp;Biometrics&nbsp;Leadership&nbsp;&amp;&nbsp;Trial&nbsp;Design.&nbsp;</strong>Serve&nbsp;as&nbsp;the&nbsp;senior&nbsp;biometrics&nbsp;lead&nbsp;across&nbsp;programs,&nbsp;shaping&nbsp;development&nbsp;strategy,&nbsp;trial&nbsp;design,&nbsp;endpoint&nbsp;selection,&nbsp;and&nbsp;risk&nbsp;mitigation.&nbsp;Contribute&nbsp;to&nbsp;Phase&nbsp;I/II&nbsp;design&nbsp;(adaptive,&nbsp;Bayesian,&nbsp;dose-finding,&nbsp;and&nbsp;novel&nbsp;endpoints);&nbsp;develop&nbsp;and&nbsp;review&nbsp;statistical&nbsp;sections&nbsp;of&nbsp;protocols,&nbsp;SAPs,&nbsp;and&nbsp;CSR/regulatory&nbsp;documents;&nbsp;and&nbsp;support&nbsp;health&nbsp;authority&nbsp;interactions,&nbsp;SRC/DMC/DSMB&nbsp;activities,&nbsp;interim&nbsp;analyses,&nbsp;and&nbsp;independent&nbsp;statistical/unblinding&nbsp;processes—ensuring&nbsp;quality&nbsp;and&nbsp;consistency&nbsp;of&nbsp;biometrics&nbsp;approaches&nbsp;with&nbsp;the&nbsp;CMO.</li> <li><strong>Organizational&nbsp;Leadership&nbsp;&amp;&nbsp;Team&nbsp;Building.&nbsp;</strong>Serve&nbsp;as&nbsp;a&nbsp;senior&nbsp;individual&nbsp;contributor&nbsp;who&nbsp;delivers&nbsp;core&nbsp;biometrics&nbsp;work&nbsp;while&nbsp;establishing&nbsp;the&nbsp;standards,&nbsp;processes,&nbsp;and&nbsp;vendor&nbsp;framework&nbsp;that&nbsp;scale&nbsp;the&nbsp;function.&nbsp;As&nbsp;the&nbsp;portfolio&nbsp;grows,&nbsp;build,&nbsp;hire,&nbsp;and&nbsp;mentor&nbsp;an&nbsp;internal&nbsp;biometrics&nbsp;team&nbsp;over&nbsp;the&nbsp;long&nbsp;term.</li> <li><strong>Sourcing&nbsp;&amp;&nbsp;Vendor&nbsp;Strategy</strong>.&nbsp;Define&nbsp;and&nbsp;implement&nbsp;Aditum’s&nbsp;biometrics&nbsp;sourcing&nbsp;model—scoping,&nbsp;selecting,&nbsp;contracting,&nbsp;and&nbsp;overseeing&nbsp;CROs,&nbsp;functional&nbsp;service&nbsp;providers,&nbsp;consultants,&nbsp;and&nbsp;specialty&nbsp;vendors—building&nbsp;relationships&nbsp;that&nbsp;provide&nbsp;surge&nbsp;capacity&nbsp;and&nbsp;specialized&nbsp;capabilities&nbsp;while&nbsp;maintaining&nbsp;capital-efficient&nbsp;resourcing.</li> <li><strong>Data&nbsp;Management,&nbsp;Systems&nbsp;&amp;&nbsp;Quality.&nbsp;</strong>Oversee&nbsp;clinical&nbsp;data&nbsp;management,&nbsp;safety&nbsp;data,&nbsp;and&nbsp;the&nbsp;systems&nbsp;ecosystem&nbsp;(EDC,&nbsp;safety&nbsp;database,&nbsp;data&nbsp;capture,&nbsp;and&nbsp;analytics/reporting&nbsp;platforms),&nbsp;and&nbsp;support&nbsp;expedited&nbsp;(E2B)&nbsp;and&nbsp;aggregate&nbsp;safety&nbsp;reporting&nbsp;(e.g.,&nbsp;DSURs)&nbsp;with&nbsp;pharmacovigilance.&nbsp;Maintain&nbsp;biometrics&nbsp;SOPs&nbsp;and&nbsp;data&nbsp;standards&nbsp;(CDISC/SDTM/ADaM),&nbsp;ensuring&nbsp;data&nbsp;quality&nbsp;and&nbsp;integrity,&nbsp;GCP/ICH&nbsp;(E6,&nbsp;E9)&nbsp;compliance,&nbsp;and&nbsp;audit&nbsp;and&nbsp;inspection&nbsp;readiness&nbsp;across&nbsp;internal&nbsp;and&nbsp;vendor&nbsp;activities.</li> <li><strong>Analytics,&nbsp;Reporting&nbsp;&amp;&nbsp;Statistical&nbsp;Programming.&nbsp;</strong>Build&nbsp;near-real-time&nbsp;visualizations&nbsp;and&nbsp;operational&nbsp;dashboards&nbsp;from&nbsp;CRO-sourced&nbsp;data&nbsp;to&nbsp;strengthen&nbsp;study&nbsp;oversight,&nbsp;and&nbsp;independently&nbsp;generate&nbsp;analyses&nbsp;and&nbsp;maintain&nbsp;analysis&nbsp;datasets&nbsp;for&nbsp;ad&nbsp;hoc&nbsp;internal&nbsp;reporting.&nbsp;Oversee&nbsp;the&nbsp;quality&nbsp;of&nbsp;vendor&nbsp;programming&nbsp;outputs&nbsp;and&nbsp;champion&nbsp;reproducible,&nbsp;well-documented&nbsp;practices.</li> <li><strong>Cross&nbsp;Functional&nbsp;&amp;&nbsp;External&nbsp;Partner&nbsp;Collaboration</strong>.&nbsp;Partner&nbsp;with&nbsp;Clinical,&nbsp;Regulatory,&nbsp;Medical,&nbsp;Translational,&nbsp;CMC,&nbsp;and&nbsp;Business&nbsp;Development&nbsp;teams,&nbsp;and&nbsp;oversee&nbsp;CROs&nbsp;and&nbsp;vendors&nbsp;across&nbsp;biometrics&nbsp;activities.&nbsp;Communicate&nbsp;complex&nbsp;statistical&nbsp;concepts&nbsp;clearly&nbsp;to&nbsp;non-statistician&nbsp;stakeholders,&nbsp;adapting&nbsp;depth&nbsp;and&nbsp;language&nbsp;to&nbsp;the&nbsp;audience.</li> </ul> <p>&nbsp;</p> <p><strong>Qualifications</strong></p> <ul> <li>PhD&nbsp;or&nbsp;MS&nbsp;in&nbsp;Biostatistics,&nbsp;Statistics,&nbsp;or&nbsp;related&nbsp;quantitative&nbsp;discipline.</li> <li>12+&nbsp;years&nbsp;in&nbsp;biometrics&nbsp;(biotech/pharma),&nbsp;including&nbsp;5+&nbsp;years&nbsp;leading&nbsp;statistical&nbsp;strategy&nbsp;and&nbsp;modern&nbsp;trial&nbsp;methodologies&nbsp;for&nbsp;Phase&nbsp;I/II&nbsp;programs—directly&nbsp;as&nbsp;study&nbsp;statistician&nbsp;or&nbsp;overseeing&nbsp;outsourced&nbsp;biostatistics—with&nbsp;hands-on&nbsp;experience&nbsp;on&nbsp;early-stage&nbsp;(first-in-human&nbsp;to&nbsp;proof-of-concept)&nbsp;programs&nbsp;and&nbsp;success&nbsp;in&nbsp;lean&nbsp;or&nbsp;startup&nbsp;environments.</li> <li>Demonstrated&nbsp;proficiency&nbsp;in&nbsp;statistical&nbsp;programming&nbsp;(R&nbsp;and/or&nbsp;SAS),&nbsp;with&nbsp;the&nbsp;ability&nbsp;to&nbsp;independently&nbsp;generate&nbsp;analyses,&nbsp;review&nbsp;analysis&nbsp;datasets&nbsp;and&nbsp;outputs,&nbsp;and&nbsp;support&nbsp;rapid&nbsp;data-driven&nbsp;decisions.</li> <li>Hands-on&nbsp;experience&nbsp;building&nbsp;interactive&nbsp;data&nbsp;visualizations&nbsp;and&nbsp;operational&nbsp;dashboards&nbsp;(e.g.,&nbsp;Spotfire,&nbsp;Tableau,&nbsp;Power&nbsp;BI,&nbsp;R&nbsp;Shiny)&nbsp;delivering&nbsp;near-real-time&nbsp;insight&nbsp;to&nbsp;clinical&nbsp;and&nbsp;operational&nbsp;teams.</li> <li>Experience&nbsp;supporting&nbsp;early-stage&nbsp;health&nbsp;authority&nbsp;interactions,&nbsp;including&nbsp;pre-IND&nbsp;and&nbsp;Type&nbsp;B/C/D&nbsp;meetings&nbsp;and&nbsp;FDA/NCA/EMA&nbsp;scientific&nbsp;advice.</li> <li>Experience&nbsp;overseeing&nbsp;clinical&nbsp;data&nbsp;management&nbsp;and&nbsp;systems&nbsp;(EDC,&nbsp;CDISC&nbsp;standards,&nbsp;analytics/reporting&nbsp;platforms)&nbsp;and&nbsp;aggregate&nbsp;safety&nbsp;reporting&nbsp;(e.g.,&nbsp;DSURs),&nbsp;with&nbsp;the&nbsp;ability&nbsp;to&nbsp;translate&nbsp;CRO/EDC&nbsp;data&nbsp;flows&nbsp;into&nbsp;decision-ready&nbsp;reporting.</li> <li>Experience&nbsp;with&nbsp;Data&nbsp;Monitoring&nbsp;Committees&nbsp;(SRC/DMC/DSMB),&nbsp;independent&nbsp;statistics/unblinding,&nbsp;and&nbsp;biometrics&nbsp;quality&nbsp;practices&nbsp;(GCP/ICH&nbsp;E6&nbsp;and&nbsp;E9,&nbsp;SOPs,&nbsp;and&nbsp;inspection&nbsp;readiness).</li> <li>Experience&nbsp;managing&nbsp;functional&nbsp;budgets&nbsp;and&nbsp;resource&nbsp;planning&nbsp;across&nbsp;internal&nbsp;and&nbsp;outsourced&nbsp;(CRO/FSP)&nbsp;capacity.</li> <li>Exceptional&nbsp;communicator&nbsp;who&nbsp;translates&nbsp;complex&nbsp;statistical&nbsp;and&nbsp;analytical&nbsp;concepts&nbsp;for&nbsp;non-technical&nbsp;audiences&nbsp;and&nbsp;presents&nbsp;confidently&nbsp;at&nbsp;governance&nbsp;and&nbsp;investment&nbsp;forums.</li> </ul> <p>&nbsp;</p> <div> <p><em>The range for this full-time position is $330,000 - 365,000 plus a target bonus, equity compensation and benefits including medical, dental, vision, and 401k. Our salary ranges are determined by role, level and location. The range displayed on our postings reflects the minimum and maximum for new hire salaries. Within the range, individual pay is determined by interview performance, job-related skills, experience and relevant education and training. Please note the range reflects base salary and does not include target bonus, equity or benefits.</em></p> </div> <div> <div id="comp-l76soz49" class="_2Hij5 _3bcaz" data-testid="richTextElement"></div> </div> </div> </div> </div> </div> </div> </section><div class="content-conclusion"><div id="comp-l76soz49" class="_2Hij5 _3bcaz" data-testid="richTextElement"> <p class="font_9"><span class="color_11">We provide equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.</span></p> </div> <section id="comp-l76soz4a1" class="_3d64y"> <div id="bgLayers_comp-l76soz4a1" class="_3wnIc" data-hook="bgLayers"> <div class="_3KzuS _3SQN-" data-testid="colorUnderlay">&nbsp;</div> <div id="bgMedia_comp-l76soz4a1" class="_2GUhU"></div> </div> <div class="_1uldx" data-testid="columns"> <div id="comp-l76soz4b2" class="_1vNJf"> <div id="bgLayers_comp-l76soz4b2" class="_3wnIc" data-hook="bgLayers"></div> </div> </div> </section></div>