Fortvita Biologics
Director, Clinical Biomarkers and Companion Diagnostics (CDx)
Fortvita Biologics, New York, New York, United States
Fortvita Biologics is a biopharmaceutical company based in the San Francisco Bay Area specializing in antibody discovery and engineering, with platforms that span antibody-drug conjugates (ADCs), bispecifics, and multispecifics. Our pipeline targets oncology, immunology, and neurodegenerative diseases and is supported by a team of over 100 across research, development, regulatory, and operational functions. With a global clinical presence and an emphasis on thoughtful design and agile execution, Fortvita is working to translate next-generation biologics from concept to clinic.
Summary
Fortvita is seeking a dynamic and experienced
Director, Clinical Biomarkers and Companion Diagnostics (CDx)
who will be accountable to drive the evaluation and implementation of novel platforms as companion diagnostics (CDx) for patient selection in support of Fortvita's clinical pipeline. The ideal candidate is expected to have deep scientific expertise in platforms relevant to clinical biomarker development, as demonstrated by high impact scientific publications and/or demonstrated contributions in support of clinical development program(s). This role requires working in a hybrid capacity at our Palo Alto, CA location Responsibilities Development and implementation of companion diagnostic strategy for assigned programs Selection and management of companion diagnostic vendor(s). Fortvita leader for all regulatory interactions surrounding companion diagnostics. Lead assessment of novel biomarker platforms. Support required regulatory filings and clinical protocol development. KOL & collaborator engagement for biomarker development and translational research studies. Work closely with Regulatory, Clinical Development, Clinical Operations to execute companion diagnostic objectives. Identify continuous process improvement opportunities. Develop, track, execute and report on goals and objectives. Support budget planning and management. Be accountable for compliant business practices. Qualifications Required Advanced degree (eg, MS, PhD, PharmD) within a job-related discipline is required. Minimum of 5 years of experience and success at biotech/pharmaceutical companies; a focus on biomarkers, CDx, and translational research is required. Experience with CDx development and knowledge of global health authority (e.g. FDA, PMDA, EMA) processes and regulations are required. Professional knowledge and hands-on scientific expertise and skills in developing and supporting novel biomarker platforms (including, but not limited to: IHC, DNA-seq, RNA-seq, FACS, and proteomics). Knowledge of oncology drug development is required. Prior experience with vendor selection and management is expected. Team players with demonstrated success with cross-functional and global teams are preferred. Experience with the development and support of related SOPs and ICF's is expected. Compensation and Benefits Include: Competitive base salary, bonus, and equity for all employees Salary Range: $200,000 to $250,000 This reflects the company's pay scale for the role. Actual compensation may vary depending on factors such as location, skills, experience, and performance. 401(k) retirement plan with employer matching contributions Comprehensive medical, dental, and vision insurance Generous paid time off policy, including company holidays and floating holidays Fortvita is proud to be an equal opportunity employer. We are committed to creating an inclusive environment for all employees and applicants and do not discriminate based on any protected characteristic under applicable federal, state, or local law. This includes but not limited to race, color, religion, national origin, ancestry, sex (including pregnancy, childbirth, and breastfeeding), gender identity or expression, sexual orientation, age, marital status, physical or mental disability, medical condition, genetic information, military or veteran status, or hair texture and style. Harassment or discrimination on the basis of any protected trait is strictly prohibited. We do not accept unsolicited resumes from staffing agencies or search firms. Any resume submitted without a signed agreement will be considered unsolicited, and Fortvita will not be obligated to pay any fees. Additional Legal Disclaimers Applicants must have legal authorization to work in the United States. In compliance with federal law, all new hires will be required to verify identity and eligibility to work in the U.S. and complete Form I-9 upon hire. Employment at Fortvita is at-will. This means that either the employee or the company may terminate the employment relationship at any time, with or without cause or advanced notice. This job description is intended to describe the general nature of the work being performed and does not constitute a contract or guarantee of employment. Fortvita reserves the right to modify job duties or responsibilities at any time, based on business needs. Reasonable accommodation: If you require reasonable accommodation during the application process, please contact Fortvita's Human Resources team at hiring@Fortvitabio.com. We are dedicated to ensuring all applicants have equal access and opportunity throughout the recruitment process.
Director, Clinical Biomarkers and Companion Diagnostics (CDx)
who will be accountable to drive the evaluation and implementation of novel platforms as companion diagnostics (CDx) for patient selection in support of Fortvita's clinical pipeline. The ideal candidate is expected to have deep scientific expertise in platforms relevant to clinical biomarker development, as demonstrated by high impact scientific publications and/or demonstrated contributions in support of clinical development program(s). This role requires working in a hybrid capacity at our Palo Alto, CA location Responsibilities Development and implementation of companion diagnostic strategy for assigned programs Selection and management of companion diagnostic vendor(s). Fortvita leader for all regulatory interactions surrounding companion diagnostics. Lead assessment of novel biomarker platforms. Support required regulatory filings and clinical protocol development. KOL & collaborator engagement for biomarker development and translational research studies. Work closely with Regulatory, Clinical Development, Clinical Operations to execute companion diagnostic objectives. Identify continuous process improvement opportunities. Develop, track, execute and report on goals and objectives. Support budget planning and management. Be accountable for compliant business practices. Qualifications Required Advanced degree (eg, MS, PhD, PharmD) within a job-related discipline is required. Minimum of 5 years of experience and success at biotech/pharmaceutical companies; a focus on biomarkers, CDx, and translational research is required. Experience with CDx development and knowledge of global health authority (e.g. FDA, PMDA, EMA) processes and regulations are required. Professional knowledge and hands-on scientific expertise and skills in developing and supporting novel biomarker platforms (including, but not limited to: IHC, DNA-seq, RNA-seq, FACS, and proteomics). Knowledge of oncology drug development is required. Prior experience with vendor selection and management is expected. Team players with demonstrated success with cross-functional and global teams are preferred. Experience with the development and support of related SOPs and ICF's is expected. Compensation and Benefits Include: Competitive base salary, bonus, and equity for all employees Salary Range: $200,000 to $250,000 This reflects the company's pay scale for the role. Actual compensation may vary depending on factors such as location, skills, experience, and performance. 401(k) retirement plan with employer matching contributions Comprehensive medical, dental, and vision insurance Generous paid time off policy, including company holidays and floating holidays Fortvita is proud to be an equal opportunity employer. We are committed to creating an inclusive environment for all employees and applicants and do not discriminate based on any protected characteristic under applicable federal, state, or local law. This includes but not limited to race, color, religion, national origin, ancestry, sex (including pregnancy, childbirth, and breastfeeding), gender identity or expression, sexual orientation, age, marital status, physical or mental disability, medical condition, genetic information, military or veteran status, or hair texture and style. Harassment or discrimination on the basis of any protected trait is strictly prohibited. We do not accept unsolicited resumes from staffing agencies or search firms. Any resume submitted without a signed agreement will be considered unsolicited, and Fortvita will not be obligated to pay any fees. Additional Legal Disclaimers Applicants must have legal authorization to work in the United States. In compliance with federal law, all new hires will be required to verify identity and eligibility to work in the U.S. and complete Form I-9 upon hire. Employment at Fortvita is at-will. This means that either the employee or the company may terminate the employment relationship at any time, with or without cause or advanced notice. This job description is intended to describe the general nature of the work being performed and does not constitute a contract or guarantee of employment. Fortvita reserves the right to modify job duties or responsibilities at any time, based on business needs. Reasonable accommodation: If you require reasonable accommodation during the application process, please contact Fortvita's Human Resources team at hiring@Fortvitabio.com. We are dedicated to ensuring all applicants have equal access and opportunity throughout the recruitment process.