Executive Director - Clinical Pharmacology and Pharmacometrics
To see similar active jobs please follow this link: Remote Management jobs
Title: Executive Director, Clinical Pharmacology and Pharmacometrics (CPP)
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 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 auto-antibodies which together form immune complexes which are fundamental in the pathogenesis of IgA nephropathy (IgAN). In addition, 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 Executive Director of Clinical Pharmacology and Pharmacometrics (CPP) will play a crucial role in leading and overseeing the clinical pharmacology & pharmacometrics activities within our organization. You will be responsible for providing scientific leadership and a collaborative working environment to advance drug candidates from IND through Phase IV. In addition, this position will collaborate with cross-functional stakeholders, including biostatistics, data management, clinical operations & medical, regulatory, CMC, and medical affairs to deliver drug development business objectives.
Responsibilities:
Develop and implement the CPP strategies across programs, indications and studies, including strategies for Phase I –III drug development and registration.
Provide guidance in interpreting the data from pharmacometrics analyses, including population PK, PK/PD, exposure-response analyses, and other quantitative modeling and simulation, to recommend dosing paradigm for different phases of clinical development; provide justification for dose selection for pivotal clinical trials.
Collaborate with Biostats, Data Management, Clinical Operations & Medical to support development projects.
Generate reports for NCA PK, PK/PD, population PK and exposure-response analyses, author (s)NDA/(s)BLA summary dossiers, contribute to documents for regulatory submissions to support milestone meetings with health authorities.
Address comments/questions from health authorities.
Present data and recommendations to program teams, external collaborators and senior management.
May mentor and supervise direct reports, oversee their deliverables, and uphold the highest scientific standards.
Help foster an environment of innovation.
Support overall CPP functional objectives.
Stay current with scientific advancements and regulatory trends in clinical pharmacology and pharmacometrics and apply knowledge to advance drug discovery and development for the organization.
Publish in peer reviewed journals.
Qualifications:
Ph.D. or MD with 10 years or more of relevant industry experience.
Prior successful experiences in global regulatory interactions, including IND, EOP1/2, scientific advice and successful approvals.
Proven experience in leading and managing sophisticated and quantitative scientific teams.
Excellent communication skills and ability to effectively collaborate with cross-functional teams and influence decision-making process.
Demonstrated knowledge of clinical drug development and development CPP strategy.
Proficiency in quantitative analyses (including population PK, PK/PD, exposure-response) using NONMEM, R and other common pharmacometrics software.
Strength in delivering results within agreed upon timelines.
Strong publication record in top-tier and peer-reviewed journals.
Experience working in a matrixed environment.
Experience in building and managing collaborations with contract research organizations (CROs), consultants, pharmaceutical partners and other outside organizations.
Ability to think critically and solve problems, possess a quick and analytical mind, and be a fast-learner and who works well in an organization that places a high value on intellectual capacity.
Excellent written and oral communication skills.
Comfortable in a fast-paced, entrepreneurial environment.
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 begins at $264,000. 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
Executive Director - Clinical Pharmacology and Pharmacometrics
To see similar active jobs please follow this link: Remote Management jobs
Title: Executive Director, Clinical Pharmacology and Pharmacometrics (CPP)
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 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 auto-antibodies which together form immune complexes which are fundamental in the pathogenesis of IgA nephropathy (IgAN). In addition, 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 Executive Director of Clinical Pharmacology and Pharmacometrics (CPP) will play a crucial role in leading and overseeing the clinical pharmacology & pharmacometrics activities within our organization. You will be responsible for providing scientific leadership and a collaborative working environment to advance drug candidates from IND through Phase IV. In addition, this position will collaborate with cross-functional stakeholders, including biostatistics, data management, clinical operations & medical, regulatory, CMC, and medical affairs to deliver drug development business objectives.
Responsibilities:
Develop and implement the CPP strategies across programs, indications and studies, including strategies for Phase I –III drug development and registration.
Provide guidance in interpreting the data from pharmacometrics analyses, including population PK, PK/PD, exposure-response analyses, and other quantitative modeling and simulation, to recommend dosing paradigm for different phases of clinical development; provide justification for dose selection for pivotal clinical trials.
Collaborate with Biostats, Data Management, Clinical Operations & Medical to support development projects.
Generate reports for NCA PK, PK/PD, population PK and exposure-response analyses, author (s)NDA/(s)BLA summary dossiers, contribute to documents for regulatory submissions to support milestone meetings with health authorities.
Address comments/questions from health authorities.
Present data and recommendations to program teams, external collaborators and senior management.
May mentor and supervise direct reports, oversee their deliverables, and uphold the highest scientific standards.
Help foster an environment of innovation.
Support overall CPP functional objectives.
Stay current with scientific advancements and regulatory trends in clinical pharmacology and pharmacometrics and apply knowledge to advance drug discovery and development for the organization.
Publish in peer reviewed journals.
Qualifications:
Ph.D. or MD with 10 years or more of relevant industry experience.
Prior successful experiences in global regulatory interactions, including IND, EOP1/2, scientific advice and successful approvals.
Proven experience in leading and managing sophisticated and quantitative scientific teams.
Excellent communication skills and ability to effectively collaborate with cross-functional teams and influence decision-making process.
Demonstrated knowledge of clinical drug development and development CPP strategy.
Proficiency in quantitative analyses (including population PK, PK/PD, exposure-response) using NONMEM, R and other common pharmacometrics software.
Strength in delivering results within agreed upon timelines.
Strong publication record in top-tier and peer-reviewed journals.
Experience working in a matrixed environment.
Experience in building and managing collaborations with contract research organizations (CROs), consultants, pharmaceutical partners and other outside organizations.
Ability to think critically and solve problems, possess a quick and analytical mind, and be a fast-learner and who works well in an organization that places a high value on intellectual capacity.
Excellent written and oral communication skills.
Comfortable in a fast-paced, entrepreneurial environment.
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 begins at $264,000. 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.