Fortvita Biologics
Senior Director or Director, Clinical Pharmacology
Fortvita Biologics, Palo Alto, California, United States, 94306
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
Senior Director or Director, Clinical Pharmacology,
who will play a critical role in supporting the Head of Clinical Pharmacology to advance Fortvita's therapeutic candidates. This role will lead the design and execution of clinical pharmacology studies, providing pharmacokinetic (PK), pharmacodynamic (PD), and biomarker data to inform clinical development programs. The ideal candidate will collaborate cross-functionally with clinical development, regulatory affairs, and translational research teams to support the progression of our diverse pipeline from early-phase trials through regulatory submission. This role requires working in a hybrid capacity at our Palo Alto, CA location. Responsibilities Study Design and Execution:
Lead the design and execution of clinical pharmacology studies, including PK/PD, dose-escalation, bioavailability, bioequivalence, and drug-drug interaction studies, under the strategic direction of the Head of Clinical Pharmacology and Pharmacometrics. Data Analysis:
Conduct analysis and interpretation of PK/PD data and biomarker results to support dose selection, safety, and efficacy evaluations. Regulatory Contributions:
Provide clinical pharmacology expertise to support regulatory submissions (IND, NDA, BLA) and interactions with global regulatory agencies (FDA, EMA, etc.). Cross-Functional Collaboration:
Work closely with clinical development, translational research, biostatistics, and regulatory teams to integrate clinical pharmacology data into development plans. Modeling and Simulation:
Apply PK/PD modeling and simulation to support optimization of dosing regimens and prediction of clinical outcomes. External Partnerships:
Support management of relationships with CROs, academic collaborators, and other external partners for clinical pharmacology activities. Team Collaboration:
Contribute to a high-performing clinical pharmacology team, fostering a culture of scientific excellence and innovation. Compliance and Quality:
Ensure all clinical pharmacology activities comply with GCP, ICH guidelines, and other relevant regulatory standards. Qualifications Required PhD, PharmD, or MD with a focus on clinical pharmacology, pharmacokinetics, or a related field. Minimum of 8 years of experience in clinical pharmacology within the biopharmaceutical industry. Strong experience in development of diverse therapeutic modalities, including biologics (e.g., monoclonal antibodies, protein therapeutics) and other drug classes. Demonstrated experience leading the design and execution of clinical pharmacology studies for early- and late-phase clinical trials. Knowledge of regulatory requirements for clinical pharmacology (FDA, EMA, etc.). Skills and Competencies Proficiency in PK/PD modeling and simulation tools (e.g., NONMEM, R, Phoenix WinNonlin, or similar). Strong analytical and problem-solving skills, with a focus on data-driven decision-making. Excellent communication and presentation skills, with the ability to convey complex scientific concepts to diverse audiences. Collaborative mindset with a track record of successful cross-functional teamwork. Preferred At least 3 years of experience in oncology therapeutics. Experience with antibody-drug conjugates (ADCs), bispecific antibodies, or other complex therapeutic modalities. Familiarity with biomarker development and translational research. Prior contributions to regulatory submissions (IND, BLA, or equivalent). Compensation and Benefits Include: Competitive base salary, bonus, and equity for all employees Salary Range: $200,000 - $270,000.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.
Senior Director or Director, Clinical Pharmacology,
who will play a critical role in supporting the Head of Clinical Pharmacology to advance Fortvita's therapeutic candidates. This role will lead the design and execution of clinical pharmacology studies, providing pharmacokinetic (PK), pharmacodynamic (PD), and biomarker data to inform clinical development programs. The ideal candidate will collaborate cross-functionally with clinical development, regulatory affairs, and translational research teams to support the progression of our diverse pipeline from early-phase trials through regulatory submission. This role requires working in a hybrid capacity at our Palo Alto, CA location. Responsibilities Study Design and Execution:
Lead the design and execution of clinical pharmacology studies, including PK/PD, dose-escalation, bioavailability, bioequivalence, and drug-drug interaction studies, under the strategic direction of the Head of Clinical Pharmacology and Pharmacometrics. Data Analysis:
Conduct analysis and interpretation of PK/PD data and biomarker results to support dose selection, safety, and efficacy evaluations. Regulatory Contributions:
Provide clinical pharmacology expertise to support regulatory submissions (IND, NDA, BLA) and interactions with global regulatory agencies (FDA, EMA, etc.). Cross-Functional Collaboration:
Work closely with clinical development, translational research, biostatistics, and regulatory teams to integrate clinical pharmacology data into development plans. Modeling and Simulation:
Apply PK/PD modeling and simulation to support optimization of dosing regimens and prediction of clinical outcomes. External Partnerships:
Support management of relationships with CROs, academic collaborators, and other external partners for clinical pharmacology activities. Team Collaboration:
Contribute to a high-performing clinical pharmacology team, fostering a culture of scientific excellence and innovation. Compliance and Quality:
Ensure all clinical pharmacology activities comply with GCP, ICH guidelines, and other relevant regulatory standards. Qualifications Required PhD, PharmD, or MD with a focus on clinical pharmacology, pharmacokinetics, or a related field. Minimum of 8 years of experience in clinical pharmacology within the biopharmaceutical industry. Strong experience in development of diverse therapeutic modalities, including biologics (e.g., monoclonal antibodies, protein therapeutics) and other drug classes. Demonstrated experience leading the design and execution of clinical pharmacology studies for early- and late-phase clinical trials. Knowledge of regulatory requirements for clinical pharmacology (FDA, EMA, etc.). Skills and Competencies Proficiency in PK/PD modeling and simulation tools (e.g., NONMEM, R, Phoenix WinNonlin, or similar). Strong analytical and problem-solving skills, with a focus on data-driven decision-making. Excellent communication and presentation skills, with the ability to convey complex scientific concepts to diverse audiences. Collaborative mindset with a track record of successful cross-functional teamwork. Preferred At least 3 years of experience in oncology therapeutics. Experience with antibody-drug conjugates (ADCs), bispecific antibodies, or other complex therapeutic modalities. Familiarity with biomarker development and translational research. Prior contributions to regulatory submissions (IND, BLA, or equivalent). Compensation and Benefits Include: Competitive base salary, bonus, and equity for all employees Salary Range: $200,000 - $270,000.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.