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Vp, Epidemiology And Medical Biostatistics


InterVenn

Remote/Flexible | South San Francisco, CA

Posted September 14

Job Description


InterVenn Biosciences is pioneering the application of a new level of understanding of biology by accessing the third – next to nucleic acids and proteins—fundamental carrier of biological information, glycans – in the context of glycoproteomics. This is the language that InterVenn is translating for the benefit of patients, researchers, and human health. Our diverse backgrounds and experiences have culminated in a unique startup working at the intersection of mass spectrometry, glycobiology, and AI to develop precision medicine products with unprecedented impact on the practice of medicine. At InterVenn, our commitment to patients drives us to strive to make our products available to patients in an accelerated timeframe, and we are, to this end, implementing unorthodox and lean, cross-functional  organizational structures that require willingness to think outside the box and take risks. If this sounds like a good fit for you, please read on.
 
We are seeking a VP of Epidemiology and Medical Biostatistics who will develop and build the structure and platform for these functions.  They will work closely with a cross-functional group that includes their counterparts in Medical Affairs and Product Vigilance, Clinical Operations, Regulatory Affairs, and Business Development to implement and ensure an encompassing strategy.  This is an outstanding opportunity to serve as a driving force in building and expanding InterVenn’s market presence and success, and one that will provide broad leadership challenge, accountability, and impact. 
 
The VP of Epidemiology and Product Vigilance will actively participate in strategic planning, ongoing and new development projects, existing and future corporate alliances, and partnering discussions.
 
Responsibilities 
 
  • Build and lead a best-in-class, high-performance team of experts with expertise in various aspects of epidemiology and clinical trial design and data analysis. Provide expert conceptual and methodological epidemiologic and biostatistical support to stakeholders across the company.
  • Take ownership of creating strategy, vision, and processes of the department of Epidemiology and Medical Biostatistics.
  • Drive and provide critical guidance and input into design of clinical studies and assembly of clinical trial protocols.
  • Oversee the biostatistical analysis of clinical trials.
  • Drive the generation of study reports and data/results dossiers for submission to regulatory authorities.
  • Participate actively in interactions with regulatory authorities, supporting the company’s office of regulatory affairs.
  • Provide expert epidemiological input into establishing internal standards, processes and policies for the use of observational/epidemiological data and the conduct of observational studies.
  • Provide expert level consultation on epidemiological issues to a variety of stakeholders across the company.
  • Lead the design and implementation of  diagnostic (and pharmaco-)epidemiology studies and interpretation of study results.
  • Critically review relevant publications, manuscripts, draft protocols as needed.
  • Provide input on patient registry design, specimen acquisition  and interpretation of data.
  • Interact closely with other functional groups that are responsible for safety evaluations to produce a quality analysis and documentation for regulatory or scientific purposes.
  • Maintain current knowledge of epidemiologic methods, data resources as well as their applications in benefit-risk evaluation, and current health authority initiatives and regulations impacting the function of safety science.
  • Work closely with the CMO and members of the senior management team to develop the overall strategic direction for InterVenn; evaluate alternative strategies, identify competitive issues, capitalize on core strengths, and develop and implement operating plans to achieve objectives for profitable growth.
  • Help represent InterVenn in the context of conferences, presentations, and industry and investment groups.

Qualifications

  • A PhD or ScD degree in epidemiology, or an MD/MPH or MD/PhD in epidemiology degree
  • Minimum of 5 years’ experience in a leadership position in the pharma/biotech or diagnostics industry, in the conduct of clinical and epidemiological studies as well as using population-based databases (relevant research experience includes clinical trial planning and analysis,  research in the areas of disease-based epidemiology, pharmacoepidemiology, or patient-reported outcomes research
  • Excellent methodological skills as applied to clinical study analysis and research epidemiology
  • Strong epidemiologic analytical skills demonstrated by expertise in epidemiologic analyses using SAS or STATAUnderstanding of the pharmaceutical and diagnostic industry in general, and specifically with regard to epidemiology resource supportExpertise in epidemiologic critique & synthesis of epidemiologic literature
  • Expertise in the design, conduct, analysis, interpretation, and communication of both observational and interventional studies
  • Experience using longitudinal national databases (e.g. NCHS), large claims databases, or electronic medical records (e.g. Optum EHR, CPRD) for epidemiologic research
  • Ability to resourcefully provide estimates of incidence and prevalence of health conditions, disease progression and disease-specific risk factors
  • Expertise in exposure estimation
  • Deep conceptual understanding of biomarker-driven health care research.
  • Working knowledge of regulatory principles applicable to safety surveillance and pharmacoepidemiology
  • Knowledge of questionnaire and case report form design (including PRO/HRQoL)
  • Ability to prioritize and organize work to meet deadlines while multi-tasking, paying close attention to detail.
  • Demonstrated management skills; ability to manage the work of MPH level epidemiologists
  • Ability to work in a multi-disciplinary team setting and employ a team approach to decision making
  • Ability to provide external networking opportunities in epidemiology as needed
  • Upon and if conditions permit, ability to travel domestically and internationally to company, scientific, regulatory, investigator, and other meetings; and ability to engage with multiple stakeholders virtually as required
  • Able to prioritize and manage several projects simultaneously.
  • A visionary business leader, who can help chart the course and evaluate development and commercial options for InterVenn.
  • Conceptual understanding of biomarker-driven health care research.
  • Ability to work in a fast-paced and ever-changing environment, as well as the proven track record of working effectively in diverse teams involving multi-functional disciplines.
  • Proven ability to develop internal relationships in a highly matrixed environment, as well as external relationships with Key Opinion Leaders and industry experts.
  • Outstanding written and oral communication skills
The VP, Epidemiology and Medical Biostatistics must be a natural leader with proven experience in leading and collaborating with teams and individuals in a global, matrix environment. The successful candidate will be an accomplished, strategic executive from the biotechnology, pharmaceutical, or medical device industry with an outstanding record of accomplishment building and leading high-performance organizations and partnerships. Experience in oncology is preferred but not required. A solid understanding of the industry’s complex requirements regarding clinical study planning and execution, regulatory environments, and market access with, an absolute commitment to competing on the highest ethical level, are essential.
 
Ensuring a diverse and inclusive workplace where we learn from each other is core to InterVenn’s values. We welcome people of different backgrounds, experiences, abilities and perspectives. We are an equal opportunity employer and a fun place to work. Come to do the best work of your life here at InterVenn.


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