BioSpace
Associate Director, Clinical Scientist, Hematology
BioSpace, Tarrytown, New York, United States, 10591
Associate Director, Clinical Scientist, Hematology Join to apply for the
Associate Director, Clinical Scientist, Hematology
role at
BioSpace
Hit Apply below to send your application for consideration Ensure that your CV is up to date, and that you have read the job specs first. Overview The Associate Director, Clinical Sciences contributes to the development, evaluation, planning and execution of hematology clinical studies and ensures scientific integrity and interpretation of study data of a clinical development program. Works in a matrix environment as part of a cross-functional team and may contribute to candidate development projects through early and/or late phase development. Reports to the Director, Clinical Sciences Hematology, Clinical Sciences and collaborates closely with Medical Director(s) to provide scientific expertise necessary to design and deliver on clinical studies and programs. Responsibilities
May function as Clinical Scientist for the program, and/or as a delegate of Therapeutic area Clinical Scientist. Contributes to program team meetings, scientific advisory boards, study steering committees and data/safety monitoring meetings; may represent the function in collaborative activities with other departments. Maintains proficient understanding of therapeutic disease areas and drug candidate including underlying disease biology, clinical manifestations and therapeutic standard practice; understands compound mechanism of action and drug landscape. Uses scientific expertise to propose, design, and execute clinical research and development studies for early and/or late-stage assets; develops strategy proposals grounded in supporting literature. Develops the Expanded Synopsis and authors clinically relevant sections; reviews other scientific portions of clinical trial protocols and amendments; authors and/or reviews documents such as medical monitoring plans, SAPs, informed consents and clinical components of Clinical Study Reports; supports development of regulatory documents; performs quality review and may approve; adjudicates and resolves cross-functional comments with minimal support. Contributes to planning and information for external/stakeholder meetings (IM, Governance, DMCs, Regulatory Authority); presents data to external investigators and internal collaborators. Applies analytical knowledge to understand how program objectives and design affect data analysis; identifies risks and designs mitigation strategies. Promotes consistent first-line medical/clinical data review techniques and conventions across studies/programs; reviews clinical data review plans and medical monitoring plans for assigned studies/programs. Qualifications
Bachelor’s degree required; advanced degree or equivalent in life science/healthcare preferred (PhD/PharmD/MSc). Typically 10 years of pharmaceutical clinical drug development experience, including basic knowledge of oncology or hematology therapeutic areas. Proficient knowledge of the drug development process, Good Clinical Practice, study design, clinical research methodology and medical writing skills. Strong teamwork skills with the ability to work cross-functionally; experience in conducting global clinical trials and execution of clinical programs. Other levels considered depending on experience. Salary and Employment Details
Salary Range (annually): $173,500.00 - $283,100.00 Seniority level: Mid-Senior level Employment type: Full-time Job function: Health Care Provider Industries: Internet News Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
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Associate Director, Clinical Scientist, Hematology
role at
BioSpace
Hit Apply below to send your application for consideration Ensure that your CV is up to date, and that you have read the job specs first. Overview The Associate Director, Clinical Sciences contributes to the development, evaluation, planning and execution of hematology clinical studies and ensures scientific integrity and interpretation of study data of a clinical development program. Works in a matrix environment as part of a cross-functional team and may contribute to candidate development projects through early and/or late phase development. Reports to the Director, Clinical Sciences Hematology, Clinical Sciences and collaborates closely with Medical Director(s) to provide scientific expertise necessary to design and deliver on clinical studies and programs. Responsibilities
May function as Clinical Scientist for the program, and/or as a delegate of Therapeutic area Clinical Scientist. Contributes to program team meetings, scientific advisory boards, study steering committees and data/safety monitoring meetings; may represent the function in collaborative activities with other departments. Maintains proficient understanding of therapeutic disease areas and drug candidate including underlying disease biology, clinical manifestations and therapeutic standard practice; understands compound mechanism of action and drug landscape. Uses scientific expertise to propose, design, and execute clinical research and development studies for early and/or late-stage assets; develops strategy proposals grounded in supporting literature. Develops the Expanded Synopsis and authors clinically relevant sections; reviews other scientific portions of clinical trial protocols and amendments; authors and/or reviews documents such as medical monitoring plans, SAPs, informed consents and clinical components of Clinical Study Reports; supports development of regulatory documents; performs quality review and may approve; adjudicates and resolves cross-functional comments with minimal support. Contributes to planning and information for external/stakeholder meetings (IM, Governance, DMCs, Regulatory Authority); presents data to external investigators and internal collaborators. Applies analytical knowledge to understand how program objectives and design affect data analysis; identifies risks and designs mitigation strategies. Promotes consistent first-line medical/clinical data review techniques and conventions across studies/programs; reviews clinical data review plans and medical monitoring plans for assigned studies/programs. Qualifications
Bachelor’s degree required; advanced degree or equivalent in life science/healthcare preferred (PhD/PharmD/MSc). Typically 10 years of pharmaceutical clinical drug development experience, including basic knowledge of oncology or hematology therapeutic areas. Proficient knowledge of the drug development process, Good Clinical Practice, study design, clinical research methodology and medical writing skills. Strong teamwork skills with the ability to work cross-functionally; experience in conducting global clinical trials and execution of clinical programs. Other levels considered depending on experience. Salary and Employment Details
Salary Range (annually): $173,500.00 - $283,100.00 Seniority level: Mid-Senior level Employment type: Full-time Job function: Health Care Provider Industries: Internet News Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
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