Clinical Development

2 weeks ago

New York, United States Anavex Full time

Anavex Life Sciences Corp. is seeking a talented and highly motivated epidemiologist to join our team. This position will have full responsibility for contributing epidemiologic expertise in the planning, design, implementation and analysis of drug development projects and evidence generation across the clinical development span. She/he/they will provide technical expertise necessary for leadership in design and analytic approaches of clinical trials and real-world evidence, interfacing with key internal and external stakeholders to support company initiatives that improve the quality and content of all clinical programs to deliver our portfolio.

Key Responsibilities

* Provide integrated epidemiology expertise through contributions to preclinical programs, clinical development, post-approval studies, and commercialization activities.


* Support clinical and safety objectives of development programs, and work with commercial teams to maximize the potential of Anavex products and ensure support for appropriate target claims and messages.


* Lead the design and execution and provide oversight for delivery and effective communication of high-quality epidemiology/RWE studies to support internal and external decision making, and to deliver clinical development programs.


* Responsible for developing the epidemiology/RWE sections of regulatory documents and submissions including RMPs, breakthrough or orphan designations.


* Support abstract and manuscript preparation for dissemination including for scientific communication, regulatory submissions, and payor dossiers and value packs.


* Provide guidance and direction to project teams, leaders, and other co-workers to ensure efficient management of project opportunities and potential risks at all stages of pharmaceutical development.


* Maintain oversight of RWE/RWD studies including negotiating appropriate timeframes and appropriate delivery of agreed study goals and effective presentation of results.


* Participate in development of new processes, SOPs, trainings, and working documents relevant for the implementation of Epidemiology/RWE.



Position will be filled at level commensurate with experience.

Requirements

* Doctoral degree (e.g. PhD, MD) and/or Master's degree (e.g. MBA, MSc) in Epidemiology, HEOR, Medicine or related field from an accredited institution, with experience in pharma, CROs, or other closely related setting.


* Minimum of eight (8) years of relevant pharmaceoepidemiology experience in Healthcare/Pharma/Biotech industry or Academia, or MD/PhD with a minimum of five (5) years of relevant pharmaceoepidemiology experience in Healthcare/Pharma/Biotech industry.


* Strong epidemiologic background with experience designing, implementing, overseeing, and communicating epidemiology/RWE and clinical studies.


* Track record of analyzing and successfully delivering evidence from clinical data and real-world data (RWD) including electronic medical records, registries and claims databases.


* Pharmaceutical industry experience across multiple phases of drug development including post-marketing activities


* Experience generating strategic medical evidence to support various stage of clinical drug development including regulatory submission, payor and value dossiers, and medical/HCP interactions.


* Ability to work across functional areas and within a matrixed organization.


* Deep knowledge of observational data sources and analytic tools.


* Ability to develop and implement strategic evidence to meet business needs for assigned therapeutic areas.


* Demonstrated strong written and oral communication skills and ability to work within a team and work independently are required.

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