- 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.
- 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.
-
Clinical Professional Development Educator
2 hours ago
Northwell Health New York, United States**Job Description**: · Performs the functions of an educator, facilitator, change agent, leader, consultant and researcher in area of expertise. Participates in the development, implementation and evaluation of orientation programs. Develops and implements staff development and c ...
-
VP, Clinical Development
1 week ago
Scismic Inc New York, United StatesJob Description · Job DescriptionScismic is supporting the growth of a late-stage, publicly traded biopharmaceutical company developing targeted radiotherapies to deliver cancer-killing radiation with cellular level precision to treat patients with high unmet medical needs. · Th ...
-
VP, Clinical Development
1 week ago
Scismic Inc New York, United StatesJob Description · Job DescriptionScismic is supporting the growth of a late-stage, publicly traded biopharmaceutical company developing targeted radiotherapies to deliver cancer-killing radiation with cellular level precision to treat patients with high unmet medical needs. · Th ...
-
Director, Clinical Development
3 weeks ago
Formation Bio New York, United States Full timeAbout Formation Bio · At Formation Bio, we are building the pharma company of the future , redefining drug development with our proprietary, tech-driven platform, focused on bringing new treatments to patients faster and more efficiently. · At Formation Bio we license clinical st ...
-
Senior Director, Clinical Development
1 week ago
Axsome Therapeutics, Inc. New York, United StatesAxsome Therapeutics, Inc. is a biopharmaceutical company developing and delivering novel therapies for the management of central nervous system (CNS) disorders. The Axsome team is a lean, dynamic group of individuals committed to addressing unmet needs for patients with CNS disor ...
-
Clinical Professional Development Educator
5 days ago
Northwell Health Manhasset, United StatesPerforms the functions of an educator, facilitator, change agent, leader, consultant and researcher in area of expertise. Participates in the development, implementation and evaluation of orientation programs. Develops and implements staff development and continuing education pro ...
-
Senior Director, Clinical Development
1 week ago
Axsome Therapeutics, Inc. New York, United StatesJOB SUMMARY · Axsome Therapeutics is seeking a Director of Clinical Development. The Director of Clinical Development is responsible for leading the clinical program for one or more product candidates within a specific therapeutic area (psychiatry or neurology). This role will ac ...
-
Director, Clinical Development- Dermatology
1 week ago
Formation Bio New York, United States Full timeAbout Formation Bio · At Formation Bio, we are building the pharma company of the future , redefining drug development with our proprietary, tech-driven platform, focused on bringing new treatments to patients faster and more efficiently. · At Formation Bio we license clinical ...
-
Medical Director, Clinical Development
2 weeks ago
Antengene New Jersey, United StatesResponsibilities: · 1.To ensure the development and implementation of clinical program strategy to meet goals and objectives. · 2.Drive clinical programs with cross functional teams to effectively deliver R&D portfolio. · 3.To be a member of the medical / clinical team and to ser ...
-
Vice President Clinical Development
1 week ago
SciPro New York, United StatesSciPro has partnered with a late-stage, publicly traded biopharmaceutical company developing targeted radiotherapies for cancer. With recent positive phase 3 data, they are expected to support an upcoming BLA filing. · They are currently seeking a Vice President of Clinical Deve ...
-
Clinical Professional Development Educator
2 days ago
Northwell Health New York, United StatesYou are here: / Clinical Professional Development Educator - Home Care | Clinical Professional... Nursing, · Clinical Professional Development and Program Management, · Clinical Professional Development and Program Management, · Northwell Health at Home · **Clinical Professio ...
-
Director, Early Clinical Development
1 week ago
Bristol-Myers Squibb New York, United StatesDirector, Early Clinical Development (MD) - Neuroscience page is loaded · Director, Early Clinical Development (MD) - Neuroscience · Apply · locations · Cambridge Crossing - MA - US · Princeton - NJ - US · San Diego - CA - US · Summit West - NJ - US · time type · Full ti ...
-
Director, Clinical Development- Dermatology
2 weeks ago
Formation Bio New York, United StatesAbout Formation BioAt Formation Bio, we are building the pharma company of the future , redefining drug development with our proprietary, tech-driven platform, focused on bringing new treatments to patients faster and more efficiently.At Formation Bio we license clinical stage dr ...
-
clinical professional development educator
2 weeks ago
Northwell Health , NY, United StatesJob Description · Performs the functions of an educator, facilitator, change agent, leader, consultant and researcher in area of expertise. Participates in the development, implementation and evaluation of orientation programs. Develops and implements staff development and contin ...
-
Senior Director, Clinical Development
2 weeks ago
Axsome Therapeutics New York, NY, United StatesJOB SUMMARY · Axsome Therapeutics is seeking a Director of Clinical Development.The Director of Clinical Development is responsible for leading the clinical program for one or more product candidates within a specific therapeutic area (psychiatry or neurology). This role will ac ...
-
Senior Director, Clinical Development
2 weeks ago
Axsome Therapeutics New York, NY, United StatesAxsome Therapeutics is seeking a Director of Clinical Development.The Director of Clinical Development is responsible for leading the clinical program for one or more product candidates within a specific therapeutic area (psychiatry or neurology). This role will act as the Clinic ...
-
Clinical Business Development Representative
6 days ago
MedElite LLC New York, United StatesAbout MedElite:MedElite provides innovative solutions for skilled nursing facilities by partnering with long-term care providers and clinicians for the benefit of not only the facilities but also the specialists and most importantly, the patients. MedElite's vision is to revoluti ...
-
Clinical Professional Development Educator
5 days ago
Northwell Health New York, United StatesReq Number 123956 · Job Description · Performs the functions of an educator, facilitator, change agent, leader, consultant and researcher in area of expertise. Participates in the development, implementation and evaluation of orientation programs. Develops and implements staff de ...
-
Clinical Professional Development Educator
1 week ago
Northwell Health New York, United StatesReq Number 118586 · Job Description · Performs the functions of an educator, facilitator, change agent, leader, consultant and researcher in area of expertise. Participates in the development, implementation and evaluation of orientation programs. Develops and implements staff de ...
-
Clinical Professional Development Educator
1 week ago
Northwell Health New York, United StatesReq Number 123209 · Job Description · Performs the functions of an educator, facilitator, change agent, leader, consultant and researcher in area of expertise. Participates in the development, implementation and evaluation of orientation programs. Develops and implements staff de ...
Clinical Development - New York, United States - Anavex
Description
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 ResponsibilitiesRequirements
Clinical Development professionals in New York City
-
Mariana de Santibanes
Social Scientist | Research Project Management
-
Samuel Greenblatt
Psychologist
-
Avery Chan
Applied Mathematics/Computer Science Student
-
Elizabeth Aaron
Data Analyst , administrative analyst
-
Vadanasundari Vedarethinam
Research Scientist
-
Carolyn M
Educational Consulting