Fortvita Biologics
Director or Senior Director, Clinical Pharmacology
Fortvita Biologics, Palo Alto, California, United States, 94306
Fortvita Biologics is a dynamic biopharmaceutical company that specializes in groundbreaking antibody discovery and engineering. Our innovative platforms encompass antibody-drug conjugates (ADCs), bispecifics, and multispecifics, with a pipeline that targets critical areas such as oncology, immunology, and neurodegenerative diseases. We pride ourselves on a talented team of over 100 professionals across research, development, regulatory, and operational functions.
Role Overview
We are on the lookout for an experienced and passionate Director or Senior Director of Clinical Pharmacology. In this pivotal role, you will collaborate directly with the Head of Clinical Pharmacology to advance our therapeutic candidates. You will lead the design and execution of clinical pharmacology studies, delivering essential pharmacokinetic (PK), pharmacodynamic (PD), and biomarker data that will inform our clinical development strategies.
Key Responsibilities
Study Design and Execution:
Spearhead the design and implementation of clinical pharmacology studies, including PK/PD, dose-escalation, and drug-drug interaction studies. Data Analysis:
Analyze and interpret PK/PD data and biomarker results to guide dose selection, safety, and efficacy assessments. Regulatory Expertise:
Utilize your clinical pharmacology acumen to support regulatory submissions (IND, NDA, BLA) and liaise with global regulatory bodies (FDA, EMA, etc.). Collaborative Efforts:
Partner closely with clinical development, translational research, biostatistics, and regulatory teams to integrate clinical pharmacology data into comprehensive development plans. Modeling and Simulation:
Employ PK/PD modeling and simulation to optimize dosing regimens and forecast clinical outcomes. External Relations:
Assist in managing relationships with CROs, academic collaborators, and other external partners for clinical pharmacology initiatives. Team Development:
Contribute to a high-performance clinical pharmacology team, promoting a culture of excellence and innovation. Compliance and Quality Assurance:
Ensure all clinical pharmacology efforts align with GCP, ICH guidelines, and relevant regulatory standards. Qualifications Required: PhD, PharmD, or MD focused on clinical pharmacology, pharmacokinetics, or a related discipline. At least 8 years of clinical pharmacology experience in the biopharmaceutical industry. Proven track record in the development of various therapeutic modalities, including biologics (e.g., monoclonal antibodies, protein therapeutics). Extensive expertise in leading clinical pharmacology study design and execution for both early and late-phase clinical trials. In-depth knowledge of regulatory requirements surrounding clinical pharmacology (FDA, EMA, etc.). Skills and Competencies Proficient in PK/PD modeling tools (e.g., NONMEM, R, Phoenix WinNonlin, or similar). Strong analytical skills and a results-oriented approach to problem-solving. Excellent communication abilities, capable of conveying intricate scientific ideas to varied audiences. Collaborative spirit with a history of successful cross-functional teamwork. Preferred: Minimum of 3 years of experience specializing in oncology therapeutics. Familiarity with antibody-drug conjugates (ADCs), bispecific antibodies, or advanced therapeutic modalities. Experience with biomarker development and translational research initiatives. Prior involvement in regulatory submissions (IND, BLA, or similar). Compensation and Benefits Competitive base salary, bonus, and equity offered to all employees. Salary Range: $200,000 - $270,000. 401(k) retirement plan with employer matching contributions. Comprehensive medical, dental, and vision insurance coverage. Generous paid time off policy, inclusive of company holidays and floating holidays. Fortvita is an equal opportunity employer. We are dedicated to fostering an inclusive environment for all employees and applicants, and we do not discriminate based on any protected characteristics under applicable federal, state, or local law. We do not accept unsolicited resumes from staffing agencies or search firms. Legal Notices Applicants must be legally authorized to work in the United States. In accordance with federal law, all new hires will need to verify their identity and eligibility to work in the U.S. and complete Form I-9 upon hire. Employment at Fortvita is at-will, meaning either employees or the company can terminate the employment relationship at any time, with or without cause or prior notice. For reasonable accommodations during the application process, please reach out to Fortvita's Human Resources team at hiring@Fortvitabio.com.
Spearhead the design and implementation of clinical pharmacology studies, including PK/PD, dose-escalation, and drug-drug interaction studies. Data Analysis:
Analyze and interpret PK/PD data and biomarker results to guide dose selection, safety, and efficacy assessments. Regulatory Expertise:
Utilize your clinical pharmacology acumen to support regulatory submissions (IND, NDA, BLA) and liaise with global regulatory bodies (FDA, EMA, etc.). Collaborative Efforts:
Partner closely with clinical development, translational research, biostatistics, and regulatory teams to integrate clinical pharmacology data into comprehensive development plans. Modeling and Simulation:
Employ PK/PD modeling and simulation to optimize dosing regimens and forecast clinical outcomes. External Relations:
Assist in managing relationships with CROs, academic collaborators, and other external partners for clinical pharmacology initiatives. Team Development:
Contribute to a high-performance clinical pharmacology team, promoting a culture of excellence and innovation. Compliance and Quality Assurance:
Ensure all clinical pharmacology efforts align with GCP, ICH guidelines, and relevant regulatory standards. Qualifications Required: PhD, PharmD, or MD focused on clinical pharmacology, pharmacokinetics, or a related discipline. At least 8 years of clinical pharmacology experience in the biopharmaceutical industry. Proven track record in the development of various therapeutic modalities, including biologics (e.g., monoclonal antibodies, protein therapeutics). Extensive expertise in leading clinical pharmacology study design and execution for both early and late-phase clinical trials. In-depth knowledge of regulatory requirements surrounding clinical pharmacology (FDA, EMA, etc.). Skills and Competencies Proficient in PK/PD modeling tools (e.g., NONMEM, R, Phoenix WinNonlin, or similar). Strong analytical skills and a results-oriented approach to problem-solving. Excellent communication abilities, capable of conveying intricate scientific ideas to varied audiences. Collaborative spirit with a history of successful cross-functional teamwork. Preferred: Minimum of 3 years of experience specializing in oncology therapeutics. Familiarity with antibody-drug conjugates (ADCs), bispecific antibodies, or advanced therapeutic modalities. Experience with biomarker development and translational research initiatives. Prior involvement in regulatory submissions (IND, BLA, or similar). Compensation and Benefits Competitive base salary, bonus, and equity offered to all employees. Salary Range: $200,000 - $270,000. 401(k) retirement plan with employer matching contributions. Comprehensive medical, dental, and vision insurance coverage. Generous paid time off policy, inclusive of company holidays and floating holidays. Fortvita is an equal opportunity employer. We are dedicated to fostering an inclusive environment for all employees and applicants, and we do not discriminate based on any protected characteristics under applicable federal, state, or local law. We do not accept unsolicited resumes from staffing agencies or search firms. Legal Notices Applicants must be legally authorized to work in the United States. In accordance with federal law, all new hires will need to verify their identity and eligibility to work in the U.S. and complete Form I-9 upon hire. Employment at Fortvita is at-will, meaning either employees or the company can terminate the employment relationship at any time, with or without cause or prior notice. For reasonable accommodations during the application process, please reach out to Fortvita's Human Resources team at hiring@Fortvitabio.com.