AD, Clinical Pharmacology

Fortvita Biologics; United States; Hybrid; USD 180,000 - 240,000; Full time

Job summary

Fortvita Biologics in the San Francisco Bay Area is seeking an Associate Director, Clinical Pharmacology, to lead the design and execution of clinical pharmacology studies, providing PK, PD, and biomarker data to inform development. You will collaborate with clinical development, regulatory affairs, and translational research teams across early- and late-phase studies.

The role emphasizes PK/PD modeling, dose optimization, and regulatory interactions with FDA/EMA, while guiding CROs and external

Qualifications

• PhD, PharmD, or MD with focus on clinical pharmacology or PK/PD.
• Experience leading design and execution of clinical pharmacology studies.
• Knowledge of regulatory requirements (FDA/EMA).

Responsibilities

• Lead design and execution of PK/PD studies across trial phases.
• Analyze PK/PD data and biomarker results to guide dose selection.
• Support regulatory submissions (IND/NDA/BLA) with clinical pharmacology input.
• Collaborate with clinical development, translational research, and biostatistics.
• Apply PK/PD modeling to optimize dosing regimens.
• Manage CROs and external partners for pharmacology activities.
• Contribute to a high-performing clinical pharmacology team.
• Ensure GCP/ICH compliance in all activities.

Skills

PK/PD modeling

Data analysis

Regulatory knowledge

Cross-functional collaboration

Communication skills

Education

PhD/PharmD/MD in clinical pharmacology

Tools

NONMEM

R

Phoenix WinNonlin

Job description

Remote (U.S.-based) - CA, CO, CT, FL, IL, IN, MA, MD, NH, NJ, NY, NC, PA, RI, TX, UT, VA, WA

Preference is San Francisco Bay Area - Hybrid

Travel up to 10% required

ABOUT THE COMPANY

Fortvita Biologics is a San Francisco Bay Area–based biopharmaceutical company advancing next-generation biologics with the goal of addressing critical health needs. Building on our foundation in oncology, we are expanding into cardiovascular and metabolic diseases, immunology, and ophthalmology, applying our scientific rigor and platform capabilities to areas of growing global health burden. Our expertise covers antibody discovery and engineering, including monoclonal, bispecific, and polyspecific antibodies, as well as antibody-drug conjugates, all supported by development strategies rooted in thoughtful design and agile execution.

Our clinical development footprint covers the U.S., Australia, and key regions across APAC and Europe, including the EU, UK, South Korea, and Japan. With more than 100 professionals across research, development, regulatory, and operations, we bring deep expertise and a global perspective to every program. Guided by our mission to transform research breakthroughs into therapeutic excellence and driven by our vision to improve lives through scientific innovation, we are committed to delivering meaningful impact for patients around the world.

POSITION SUMMARY

Fortvita is seeking a dynamic and experienced Associate 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.

ESSENTIAL FUNCTIONS AND 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.
• Other Duties as Assigned

REQUIRED QUALIFICATIONS

• PhD, PharmD, or MD with a focus on clinical pharmacology, pharmacokinetics, or a related field.
• Minimum of 6 years of experience in clinical pharmacology within the biopharmaceutical industry.
• At least 2 years of experience in oncology therapeutics.
• 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.).

PREFERRED QUALIFICATIONS

• 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).

COMPETENCIES/CORE SKILLS

• 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.

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 [e-mail]. We are dedicated to ensuring all applicants have equal access and opportunity throughout the recruitment process.