Director - Clinical Scientist
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Title: Director, Clinical Scientist
Location: Remote
About Us:
Vera Therapeutics (Nasdaq: VERA), is a late-stage biotechnology company focused on developing treatments for serious immunological diseases. Vera’s mission is to advance treatments that target the source of immunologic diseases in order to change the standard of care for patients. Vera’s lead product candidate is atacicept, a fully humanized fusion protein self-administered at home as a subcutaneous injection once weekly that blocks both B-cell Activating Factor (BAFF) and A Proliferation Inducing Ligand (APRIL), which stimulate B cells and plasma cells to produce galactose-deficient IgA1 (Gd-IgA1) and associated autoantibodies, which together form immune complexes that are fundamental in the pathogenesis of IgA nephropathy (IgAN). Vera is also considering evaluating the role of atacicept in other immunologic disorders. Additionally, Vera is developing MAU868, a monoclonal antibody designed to neutralize infection with BK Virus, a polyomavirus that can have devastating consequences in certain settings such as kidney transplant. For more information, please visit: www.veratx.com.
Our values are the cornerstone of our culture. Our values inspire us every day and guide everything we do—from how we hire great people, to advancing our mission together, to achieving our ultimate goal to improve medical treatment for patients suffering from immunological diseases.
Position Summary:
The Director, Clinical Scientist, leads in the development, evaluation, planning and execution of clinical studies and ensures scientific integrity and interpretation of study data of a clinical development program. The Director, Clinical Scientist leads in a matrix environment as part of a cross-functional team and may contribute to drug-candidate development projects through early and/or late phase development. The Director, Clinical Scientist reports to Vice President, Clinical Research.
Responsibilities:
May function as lead Clinical Scientist for program, and/or as Member of the Clinical Study Team.
Contributes to program team meetings, scientific advisory boards, study steering committees and data/safety monitoring meetings; may represent function in collaborative activities with other departments.
Maintains advanced understanding of therapeutic disease area(s) and drug candidate including underlying disease biology, clinical manifestations and therapeutic standard practice, compound(s) including mechanism of action and drug landscape.
Collaborates with medical affairs to develop the scientific publication and communication plans aligned with the overall medical objectives for company’s marketed compounds and in development, participates in data analysis efforts, editing and preparation of publications for submission, while ensuring adherence to policies and procedures established by the pharmaceutical industry (GPP), ICMJE, ISMPP etc.
Collaborates with medical affairs in reviewing data to create scientifically accurate and fair-balanced content that communicates and educates audiences on complex medical and scientific concepts, treatment options, emerging standards of care, and competitive intelligence.
Applies advanced scientific expertise to propose, design, and execute clinical research and development studies for early and/or late-stage assets; able to conceive and communicate strategy proposals well-grounded in supporting literature.
Authors and/or reviews documents related to trials, such as medical monitoring plans, SAPs, informed consents and clinical components of the Clinical Study Reports and independently supports the development of regulatory documents; performs quality review and/or approval; adjudicates and resolve cross functional comments independently.
Independently leads planning and prepares information for external /stakeholder meetings (IM, Governance, DMCs, Regulatory Authority); Presents data and information to external investigators (SIV) and internal collaborators.
Performs clinical/medical data review, including safety monitoring and activities and procedures that ensure patient safety; Maintains compliance in accordance with FDA, EMEA, ICH and GCP guidelines as well as applicable SOPs regarding clinical safety.
Ensures consistent first line medical/clinical data review techniques and conventions across studies/programs; leads drafting/updating/review of medical/clinical data review plan; ensures execution where appropriate for assigned studies/program.
Qualifications:
Bachelor's Degree in a related field and 6 years of related scientific experience OR Advanced degree (Ph.D., Sc.D., M.S., M.P.H.) in a related field and 4 years of related scientific experience.
Specific experience with compounds in glomerular disease, autoimmune disease, Nephrology is a plus
Ability to understand, critically analyze, and interpret data and summarize complex results in an unambiguous, concise, and scientifically accurate manner.
Well-developed interpersonal and communication skills, with experience interacting with and influencing people, and building strong, positive relationships.
Proven organizational skills and the ability and flexibility to work across a variety of teams and manage multiple competing priorities in a fast-paced startup environment.
Detail-oriented, with exceptional organizational and project management skills.
Understands the principles of scientific writing; writing with the audience in mind and conveying messages in a clear and concise manner.
Proficient in using scientific writing tools (e.g., Microsoft Office suite, document management systems, reference management software) and ability to quickly learn new software applications.
Vera Therapeutics Inc. is an equal-opportunity employer.
Vera Therapeutics is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the anticipated base pay range is $203,000 - $242,000. The exact base pay offered for this role will depend on various factors, including but not limited to the candidate’s geography, qualifications, skills, and experience.
At Vera, base pay is only one part of your total compensation package. The successful candidate will be eligible for an annual performance incentive bonus, new hire equity, and ongoing performance-based equity. Vera Therapeutics also offers various benefits offerings, including, but not limited to, medical, dental, and vision insurance, 401k match, flexible time off, and a number of paid holidays.
Notice to Recruiters/Staffing Agencies
Recruiters and staffing agencies should not contact Vera Therapeutics through this page. All recruitment vendors (search firms, recruitment agencies, and staffing companies) are prohibited from contacting our hiring manager(s), executive team members, or employees.
We require that all recruiters and staffing agencies have a fully executed, formal written agreement on file.
Vera Therapeutics’ receipt or acceptance of an unsolicited resume submitted by a vendor organization to this website or employee does not constitute an actual or implied contract between Vera Therapeutics and such organization and will be considered unsolicited and Vera Therapeutics will not be responsible for related fees.
Fraud Alert
To all candidates: your personal information and online safety are a top priority for us. At Vera Therapeutics, recruiters only direct candidates to apply through our official career page at https://veratx.com/careers/.
Recruiters will always contact you using the domain of veratx.com. We will never request payments, ask for financial account information or sensitive information like social security numbers. If you are unsure if a message is from Vera Therapeutics, please email human resources.
About the job
Director - Clinical Scientist
To see similar active jobs please follow this link: Remote Management jobs
Title: Director, Clinical Scientist
Location: Remote
About Us:
Vera Therapeutics (Nasdaq: VERA), is a late-stage biotechnology company focused on developing treatments for serious immunological diseases. Vera’s mission is to advance treatments that target the source of immunologic diseases in order to change the standard of care for patients. Vera’s lead product candidate is atacicept, a fully humanized fusion protein self-administered at home as a subcutaneous injection once weekly that blocks both B-cell Activating Factor (BAFF) and A Proliferation Inducing Ligand (APRIL), which stimulate B cells and plasma cells to produce galactose-deficient IgA1 (Gd-IgA1) and associated autoantibodies, which together form immune complexes that are fundamental in the pathogenesis of IgA nephropathy (IgAN). Vera is also considering evaluating the role of atacicept in other immunologic disorders. Additionally, Vera is developing MAU868, a monoclonal antibody designed to neutralize infection with BK Virus, a polyomavirus that can have devastating consequences in certain settings such as kidney transplant. For more information, please visit: www.veratx.com.
Our values are the cornerstone of our culture. Our values inspire us every day and guide everything we do—from how we hire great people, to advancing our mission together, to achieving our ultimate goal to improve medical treatment for patients suffering from immunological diseases.
Position Summary:
The Director, Clinical Scientist, leads in the development, evaluation, planning and execution of clinical studies and ensures scientific integrity and interpretation of study data of a clinical development program. The Director, Clinical Scientist leads in a matrix environment as part of a cross-functional team and may contribute to drug-candidate development projects through early and/or late phase development. The Director, Clinical Scientist reports to Vice President, Clinical Research.
Responsibilities:
May function as lead Clinical Scientist for program, and/or as Member of the Clinical Study Team.
Contributes to program team meetings, scientific advisory boards, study steering committees and data/safety monitoring meetings; may represent function in collaborative activities with other departments.
Maintains advanced understanding of therapeutic disease area(s) and drug candidate including underlying disease biology, clinical manifestations and therapeutic standard practice, compound(s) including mechanism of action and drug landscape.
Collaborates with medical affairs to develop the scientific publication and communication plans aligned with the overall medical objectives for company’s marketed compounds and in development, participates in data analysis efforts, editing and preparation of publications for submission, while ensuring adherence to policies and procedures established by the pharmaceutical industry (GPP), ICMJE, ISMPP etc.
Collaborates with medical affairs in reviewing data to create scientifically accurate and fair-balanced content that communicates and educates audiences on complex medical and scientific concepts, treatment options, emerging standards of care, and competitive intelligence.
Applies advanced scientific expertise to propose, design, and execute clinical research and development studies for early and/or late-stage assets; able to conceive and communicate strategy proposals well-grounded in supporting literature.
Authors and/or reviews documents related to trials, such as medical monitoring plans, SAPs, informed consents and clinical components of the Clinical Study Reports and independently supports the development of regulatory documents; performs quality review and/or approval; adjudicates and resolve cross functional comments independently.
Independently leads planning and prepares information for external /stakeholder meetings (IM, Governance, DMCs, Regulatory Authority); Presents data and information to external investigators (SIV) and internal collaborators.
Performs clinical/medical data review, including safety monitoring and activities and procedures that ensure patient safety; Maintains compliance in accordance with FDA, EMEA, ICH and GCP guidelines as well as applicable SOPs regarding clinical safety.
Ensures consistent first line medical/clinical data review techniques and conventions across studies/programs; leads drafting/updating/review of medical/clinical data review plan; ensures execution where appropriate for assigned studies/program.
Qualifications:
Bachelor's Degree in a related field and 6 years of related scientific experience OR Advanced degree (Ph.D., Sc.D., M.S., M.P.H.) in a related field and 4 years of related scientific experience.
Specific experience with compounds in glomerular disease, autoimmune disease, Nephrology is a plus
Ability to understand, critically analyze, and interpret data and summarize complex results in an unambiguous, concise, and scientifically accurate manner.
Well-developed interpersonal and communication skills, with experience interacting with and influencing people, and building strong, positive relationships.
Proven organizational skills and the ability and flexibility to work across a variety of teams and manage multiple competing priorities in a fast-paced startup environment.
Detail-oriented, with exceptional organizational and project management skills.
Understands the principles of scientific writing; writing with the audience in mind and conveying messages in a clear and concise manner.
Proficient in using scientific writing tools (e.g., Microsoft Office suite, document management systems, reference management software) and ability to quickly learn new software applications.
Vera Therapeutics Inc. is an equal-opportunity employer.
Vera Therapeutics is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the anticipated base pay range is $203,000 - $242,000. The exact base pay offered for this role will depend on various factors, including but not limited to the candidate’s geography, qualifications, skills, and experience.
At Vera, base pay is only one part of your total compensation package. The successful candidate will be eligible for an annual performance incentive bonus, new hire equity, and ongoing performance-based equity. Vera Therapeutics also offers various benefits offerings, including, but not limited to, medical, dental, and vision insurance, 401k match, flexible time off, and a number of paid holidays.
Notice to Recruiters/Staffing Agencies
Recruiters and staffing agencies should not contact Vera Therapeutics through this page. All recruitment vendors (search firms, recruitment agencies, and staffing companies) are prohibited from contacting our hiring manager(s), executive team members, or employees.
We require that all recruiters and staffing agencies have a fully executed, formal written agreement on file.
Vera Therapeutics’ receipt or acceptance of an unsolicited resume submitted by a vendor organization to this website or employee does not constitute an actual or implied contract between Vera Therapeutics and such organization and will be considered unsolicited and Vera Therapeutics will not be responsible for related fees.
Fraud Alert
To all candidates: your personal information and online safety are a top priority for us. At Vera Therapeutics, recruiters only direct candidates to apply through our official career page at https://veratx.com/careers/.
Recruiters will always contact you using the domain of veratx.com. We will never request payments, ask for financial account information or sensitive information like social security numbers. If you are unsure if a message is from Vera Therapeutics, please email human resources.