Director/Senior Director, Clinical Pharmacology

Lakefront Biotherapeutics; San Francisco (CA); In loco; USD 230.000 - 300.000; Tempo pieno

Vantaggi offerti da questo lavoro

Performance Bonus

Comprehensive benefits

Descrizione del lavoro

Lakefront Biotherapeutics is seeking a Director/Senior Director of Clinical Pharmacology to shape strategy and execution across our autoimmune pipeline. You will lead PK/PD modeling, dose selection, and regulatory submissions, collaborating with translational, regulatory, and clinical teams.

The role requires 10+ years (Director) or 15+ years (Senior Director) in clinical pharmacology with immunology-focused experience, and strong communication across stakeholders.

Competenze

• Ph.D. in Pharmacokinetics, Pharmacology, Pharmaceutical Sciences, or related field; PharmD considered with experience.
• 10+ years (Director) or 15+ years (Senior Director) in clinical pharmacology leadership.
• Strong PK/PKPD, modeling, and population modeling knowledge; experience with R/NONMEM/Phoenix.

Mansioni

• Lead clinical pharmacology strategy and implementation across programs from FIH through proof-of-concept and beyond.
• Develop and execute multidisciplinary clinical pharmacology plans including PK, PK/PD, exposure-response, and dose optimization.
• Analyze data from trials to identify dose- and exposure-related trends for safety and efficacy.
• Contribute to study design to support evidence generation and objectives.
• Integrate modeling across development to inform dose selection and labeling.
• Oversee CROs and vendors ensuring rigor and timelines.
• Represent Clinical Pharmacology on cross-functional project teams.
• Author/regulatory documents including IND/IMPD sections and NDA/BLA components.
• Interact with FDA/EMA and health authorities on pharmacology matters.
• Support lifecycle management and BD due diligence as needed.
• Stay updated with regulatory guidance and pharmacometrics advances.
• Help build best-in-class Clinical Pharmacology capabilities.

Conoscenze

PK/PD modeling

Population modeling

Quantitative modeling

Scientific communication

Cross-functional collaboration

Regulatory interactions

Immunology knowledge

Formazione

Ph.D. in Pharmacokinetics or related

PharmD considered with relevant experience

Strumenti

R

NONMEM

Phoenix

Descrizione del lavoro

About Lakefront Biotherapeutics

Lakefront Biotherapeutics is a global biotech with offices in Belgium, Chicago and San Francisco, focused on building a differentiated immunology and inflammation pipeline to address serious diseases with high unmet medical need. Our pipeline is anchored by T‑cell engager programs, led by a potential first‑in‑class clinical asset and complemented by an exciting preclinical portfolio in autoimmune disease.

About Lakefront Biotherapeutics

Lakefront Biotherapeutics is a global biotech with offices in Belgium, Chicago and San Francisco, focused on building a differentiated immunology and inflammation pipeline to address serious diseases with high unmet medical need. Our pipeline is anchored by T‑cell engager programs, led by a potential first‑in‑class clinical asset and complemented by an exciting preclinical portfolio in autoimmune disease.

Our lead asset is being developed for severe immune‑mediated diseases, while additional preclinical programs expand the long‑term potential of our R&D pipeline. At Lakefront, we focus on advancing programs with strong biological rationale, clear clinical proof of concept and large commercial opportunities.

Are you ready to transform lives and be part of a journey like no other? We are building a company where science, execution, and accountability matter. Rather than layers of hierarchy, we operate with small, empowered teams that work hands‑on across development stages to move programs forward efficiently and thoughtfully.

We are looking for people who want to contribute directly, who are motivated by solving real problems, collaborating across disciplines, and taking ownership from idea to impact. At Lakefront, every role plays a part in shaping the future of medicines that have the potential to make a meaningful difference for patients.

If you are driven to improve the lives of patients, energized by execution, and excited to help build a growing company with a strong balance sheet, we look forward to meeting you.

The Role

We are seeking a Director or Senior Director of Clinical Pharmacology to lead clinical pharmacology strategy and execution across our autoimmune pipeline. This is a key high-impact, high-visibility role that will shape how our molecules are characterized, dosed, and differentiated in the clinic. You will work at the intersection of quantitative modeling, translational medicine, regulatory strategy, and clinical development — and will have the opportunity to build out the clinical pharmacology function as the company grows.

What You’ll Do

• Lead clinical pharmacology strategy and implementation across one or more programs, from first-in-human through proof-of-concept and beyond
• Develop and execute multidisciplinary clinical pharmacology plans including characterization of PK, evaluation of PK/PD and exposure-response relationships, and dose optimization strategies
• Analyze data from ongoing and completed clinical trials to identify dose- and exposure-related trends and signals in safety, efficacy, and patient subgroups to support development decisions
• Contribute to the design of clinical studies to support evidence generation and development objectives
• Integrate quantitative modeling techniques (e.g. population PK, PK/PD, PBPK, QSP) throughout development to inform dose selection, trial design, and labeling as needed
• Oversee and manage CRO clinical pharmacology and modeling vendors and contract sciences, ensuring scientific rigor and timeline adherence
• Represent the Clinical Pharmacology function on project teams with membership from clinical, regulatory, translational, CMC, and others
• Author and review regulatory documents including IND/IMPD sections, clinical pharmacology summaries, briefing documents, and NDA/BLA components
• Represent the company in interactions with FDA, EMA, and other health authorities on clinical pharmacology matters
• Contribute to lifecycle management strategies and support business development due diligence as needed
• Stay current with evolving regulatory guidance and methodological advances relevant to clinical pharmacology, pharmacometrics, and immunology and inflammation clinical development
• Help build best-in-class Clinical Pharmacology and Pharmacometrics capabilities as the organization grows

What You Bring

• Ph.D. in Pharmacokinetics, Pharmacology, Pharmaceutical Sciences, or a closely related discipline; PharmD considered with relevant industry experience
• 10+ years (Director) or 15+ year (Senior Director) of industry experience in clinical pharmacology, with direct experience leading Clinical Pharmacology strategy and execution for clinical-stage programs through IND and beyond
• Strong foundation in the principles of PK, PK/PD, clinical pharmacology, and quantitative modeling techniques, compartmental and noncompartmental analysis, and population modeling; working knowledge of R, NONMEM, Phoenix, or equivalent platforms
• Demonstrated experience authoring regulatory documents and interacting with health authorities
• Experience in immunology, inflammation, or autoimmune disease areas strongly preferred
• Track record of operating effectively in cross-functional teams in a lean, fast-moving biotech environment
• Strong scientific communication skills, both written and oral — ability to translate complex Clinical Pharmacology concepts for clinical, regulatory, and executive audiences with a demonstrated record of meaningful impact

Base compensation for this position ranges from $230,000 - 300,000. Actual base compensation will be determined based on a variety of factors including experience, qualifications, job-related knowledge, demonstrated skills and geographic location. The company reserves the right to modify base salary ranges at any time. In addition, this position is eligible for participation in Lakefront Biotherapeutics’ performance bonus plan. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support important moments in life.

At Lakefront Biotherapeutics, we are committed to attracting individuals who bring strong expertise, integrity, and a collaborative mindset. We value people who take ownership, work effectively across teams, and want to contribute to meaningful progress.

You will join a highly motivated and supportive team working together to advance our pipeline and strengthen how we operate. As we continue to build and grow, we offer an environment where individuals can develop, take on responsibility, and make a tangible impact.

Lakefront Biotherapeutics is dedicated to ensuring equal employment opportunities. Our hiring decisions are based on merit, considering qualifications, skills, performance, and achievements. We strictly prohibit discrimination against any employee or job applicant based on personal characteristics that are unrelated to their job.