Director, Clinical Pharmacology

2 days ago

Foster City CA United States Dren Bio, Inc. Full time

Dren Bio (the "Company") is a privately held, clinical stage biopharmaceutical company focused on developing therapeutic antibodies for the treatment of cancer, autoimmune and other serious diseases. The Company's management team and scientific advisors have profound expertise covering the discovery and development of engineered antibodies designed to selectively target and deplete pathological cells. Dren Bio's pipeline is currently comprised of two distinct drug discovery programs. The Company's first program surrounds DR-01, its lead product candidate, which induces antibody-mediated killing of a cell type that is responsible for a multitude of hematologic malignancies and plays a key role in various autoimmune diseases. The Company's second program surrounds its Targeted Myeloid Engager and Phagocytosis Platform, a proprietary bispecific antibody-based technology that provides a novel mechanism of action to selectively engage myeloid cells for (1) targeted depletion of pathologic cells and other disease-inducing agents and (2) inducing localized immunostimulation. The engagement of antigen presenting cells has the potential to elicit a sustained, durable response.

Function:

Clinical Pharmacology

Level:

Director

Location:

Foster City, CA

About the Opportunity:

Dren Bio is seeking a Director of Clinical Pharmacology who will be responsible for development and implementation of clinical pharmacology and pharmacometric strategies for the company's growing portfolio of therapeutic antibodies with enhanced ADCC and/or targeted myeloid-engaging function. The Director will work in close partnership with other key functions such as Clinical Development, Biostatistics, Regulatory Affairs and Translational Science to plan and review study designs, analyze and interpret pharmacokinetic and pharmacodynamic data; apply Model-Informed Drug Development and principles of quantitative clinical pharmacology to ensure optimal drug development and author the clinical pharmacology sections of regulatory documents.

Role and Responsibilities:
  1. As part of a cross functional team, develop and execute clinical pharmacology and pharmacometrics strategies for biotherapeutic drug candidates at all phases of clinical development.
  2. Develop clinical pharmacology plans to support developmental therapies (many are first in class) in the Dren Bio pipeline and represent the clinical pharmacology function in health authority interactions.
  3. Author and review relevant sections of IND/CTA filings as well as NDA/MAA/BLA submissions and other key documents including investigators brochures, clinical study protocols and reports, and regulatory briefing documents.
  4. Analyze, interpret, summarize, and present clinical pharmacology data to internal project teams, senior management, and to global health authorities.
  5. Work closely with preclinical teams to ensure adequate study design to support FIH studies. Analyze and interpret preclinical data to support dose and regimen selection for FIH studies.
  6. Provide modeling and simulation and characterize exposure-response relationships to optimize dose selection for studies and for special populations.
Education, Experience and Qualification Requirements:
  1. PhD in pharmaceutical sciences, pharmacology or equivalent professional degree e.g. PharmD.
  2. 7+ years of experience in clinical pharmacology, modeling & simulation in the biopharmaceutical Industry.
  3. Experience in leading the design and implementation of clinical pharmacology studies including special populations, ethnic sensitivity, and pediatric studies and integrating results into regulatory submissions, and product labels.
  4. Established track-record of interaction with global health authorities, authoring regulatory documents and successful INDs (required) and NDA/BLAs (preferred).
Core Competencies, Knowledge and Skill Requirements:
  1. Team Player, with profound understanding that clinical development is a cross-functional effort.
  2. Active and effective communicator, both written and oral.
  3. Hands-on experience with NCA using Phoenix WinNonlin and quantitative PK/PD approaches.
  4. Expertise with population modelling and simulation software (NONMEM, Monolix, R, etc).
  5. Prior experience in large molecule and oncology drug development.
  6. Knowledge of relevant global regulatory requirements and guidance.
Salaries, Benefits and Other Employee Perks:

Dren Bio strongly believes in investing in, and rewarding, its employees. This philosophy is embodied in the Company’s total rewards program, which includes competitive cash compensation, equity incentive awards, and employer sponsored benefit offerings. The base pay range for this position at commencement of employment is expected to be between $190,000 and $240,000 per year. At Dren Bio, pay ranges are determined by role, level(s), and location. The range displayed in this job posting reflects the minimum and maximum new hire pay for candidates located across all United States job markets. Within the range, individual pay will be determined by work location and additional factors, including job-related skills, experience, and relevant education or training. During the hiring process, Dren Bio’s Human Resources department can share more about the specific pay range based on the market location of the candidate.

Employment Practices:

Dren Bio is an equal opportunity employer. Employment decisions are based on merit and business needs. Dren Bio will not discriminate against any job applicant because of race, color, national origin, ancestry, gender, sexual orientation, age, religion, creed, physical or mental disability, gender identity, medical condition, pregnancy, marital status, veteran status, or any other characteristic protected by federal, state or local law.

Interested Applicants:

Please send resume and cover letter to

#J-18808-Ljbffr

  • Director, Clinical Pharmacology

    1 day ago

    Paramus, NJ, United States SK Life Science Full time

    Director, Clinical Pharmacology Job Locations: US-NJ-Paramus ID: 2024-1840 Category: Clinical Operations Type: Regular Full-Time Overview The Clinical Pharmacology, Director role will effectively provide support for the design, execution, interpretation, and reporting of clinical pharmacokinetic/pharmacodynamic (PK/PD) studies. This individual will...

  • Director of Clinical Pharmacology

    1 day ago

    , GA, United States EPM Scientific - Phaidon International Full time

    We have a current opportunity for a Director of Clinical Pharmacology on a permanent basis. The position is fully remote. Key Responsibilities: Lead the design, execution, and analysis of clinical pharmacology studies, including first-in-human (FIH), pharmacokinetics (PK), pharmacodynamics (PD), and drug-drug interaction (DDI) studies. Develop clinical...

  • Director Clinical Pharmacology

    2 days ago

    King of Prussia, Montgomery County, United States CSL Behring Full time

    CSL Behring Director Clinical Pharmacology King of Prussia, Pennsylvania Apply Now CSL Behring is a global biotechnology leader, guided by a promise to save and improve lives. Millions of people around the world are living with rare and serious medical conditions. CSL Behring is committed to delivering medicines that improve their lives. With operations in...

  • Director, Clinical Pharmacology

    1 day ago

    , MS, United States Immunovant, Inc. Full time

    Organizational Overview: Immunovant, Inc. is a clinical-stage immunology company dedicated to enabling normal lives for people with autoimmune diseases. As trailblazer in anti-FcRn technology, the Company is developing innovative, targeted therapies to meet the complex and variable needs of people with autoimmune diseases. The Role: The Clinical...

  • Lead Clinical Pharmacology Specialist

    1 week ago

    Foster City, California, United States Gilead Sciences, Inc. Full time

    Gilead Sciences, Inc. is a dynamic and innovative company at the forefront of medical research and development.We are seeking an exceptional Lead Clinical Pharmacology Specialist to join our team and contribute to our mission of improving human health.The successful candidate will be responsible for leading clinical pharmacology studies of increasing...

  • Director, Clinical Pharmacology Lead

    2 days ago

    Boston, MA, United States Organon & Co. Full time

    Organon & Co. Director, Clinical Pharmacology Lead Boston, Massachusetts Apply Now This position can be 100% remote in the US The Director, Translational Medicine and Early Development (TMED) Lead will be responsible for contributing and/or devising the early clinical development & translational medicine development strategy supporting development assets...

  • Director/Senior Director, DMPK and Clinical Pharmacology

    1 day ago

    South San Francisco, CA, United States IDEAYA Biosciences Full time

    What you’ll do: Provide expert guidance on all aspects of clinical pharmacology programs supporting drug discovery and clinical development, including authoring clinical protocols, study reports, data analysis (exposure/efficacy/safety) to supporting development and registration of IDEAYA products. One of the key roles of this position is to apply...

  • Associate Director of Clinical Pharmacology

    1 day ago

    , MA, United States EPM Scientific - Phaidon International Full time

    Key Responsibilities : Lead and contribute to the clinical pharmacology strategy, ensuring alignment with overall development plans and therapeutic goals. Design and oversee clinical pharmacology studies, including pharmacokinetics (PK), pharmacodynamics (PD), dose optimization, and biomarker strategies. Interpret and analyze clinical pharmacology data,...

  • Director, Clinical Pharmacology

    1 day ago

    Durham, NC, United States IQVIA Argentina Full time

    This position is Full-Time and Remote-based anywhere in the United States or Canada. Why DSSS? Data Sciences Staffing Solutions, DSSS or DS3, is a unit within IQVIA that provides our sponsors with fully dedicated resources through a Functional Service Provider (FSP) partnership. This means you get all the benefits of working for an industry leading global...

  • Director of Clinical Pharmacology Modeling and Simulation

    1 day ago

    Collegeville, PA, United States GlaxoSmithKline Full time

    Site Name: Durham Blackwell Street, Upper Providence, WalthamPosted Date: Nov 13 2024GSK has an inspiring ambition: by uniting science, technology and talent we aim to positively impact the health of 2.5 billion people over the next ten years. We will get ahead of disease together with our R&D approach of focusing on the science of the immune system, human...

  • Director of Clinical Pharmacology Modeling and Simulation

    2 days ago

    Waltham, MA, United States GlaxoSmithKline Full time

    Site Name: Durham Blackwell Street, Upper Providence, WalthamPosted Date: Nov 13 2024GSK has an inspiring ambition: by uniting science, technology and talent we aim to positively impact the health of 2.5 billion people over the next ten years. We will get ahead of disease together with our R&D approach of focusing on the science of the immune system, human...

  • Senior Manager, Clinical Pharmacology

    1 day ago

    Waltham, MA, United States Deciphera Pharmaceuticals, Inc Full time

    Deciphera, a member of ONO, is a biopharmaceutical company focused on discovering, developing and commercializing important new medicines to improve the lives of people with cancer. We are leveraging our proprietary switch-control kinase inhibitor platform and deep expertise in kinase biology to develop a broad portfolio of innovative medicines. Enabled by...

  • Principal Scientist

    4 weeks ago

    Cambridge, MA, United States Delphia Therapeutics Full time

    Principal Scientist / Associate Director, In vivo PharmacologyAbout Us:Delphia is a biotechnology company on a mission in the service of patients to pioneer an entirely new field of cancer biology, Activation Lethality, that targets cancer’s vulnerability to oncogene overactivation. Together, we are working to advance first-in-class targeted cancer...

  • Associate Director, Clinical Pharmacology

    2 days ago

    Lincoln, NE, United States Allergan Full time

    Company Description AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and...

  • Clinical Pharmacology Modeling and Simulation

    1 day ago

    Thousand Oaks, CA, United States Amgen SA Full time

    Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four...

  • Clinical Pharmacology, Modeling and Simulation

    3 months ago

    Billerica, MA, United States Parexel International Corporation Full time

    Parexel is one of the only CROs to provide a broad depth of Clinical Pharmacology, Modeling and Simulation (CPMS) expertise to our clients, and the group is growing its capabilities and expanding globally!We currently havetremendous opportunities available to join this extremely collaborative and super friendly team! If you're looking for an opportunity to...

  • Associate Director of In Vivo Pharmacology

    1 day ago

    Piscataway Township, NJ, United States Tbwa ChiatDay Inc Full time

    Associate Director of In Vivo Pharmacology Piscataway, New Jersey, United States Company Information Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including...

  • In Vivo Research Associate

    1 week ago

    Foster City, California, United States R&D Partners Full time

    Preclinical Pharmacology Position OverviewWe are seeking a skilled In Vivo Research Associate to join our Oncology in vivo pharmacology team at R&D Partners.This role involves providing study support for evaluating novel oncology therapeutics in pre-clinical models, including daily in vivo study execution, data analysis, and project team responsibilities.Key...

  • Clinical Pharmacology, Modeling and Simulation

    7 days ago

    Billerica, MA, United States Parexel International Corporation Full time

    Parexel is one of the only CROs to provide a broad depth of Clinical Pharmacology, Modeling and Simulation (CPMS) expertise to our clients, and the group is growing its capabilities and expanding globally!We currently havetremendous opportunities available to join this extremely collaborative and super friendly team! If you're looking for an opportunity to...

  • Clinical Pharmacology Leadership Position

    1 week ago

    Jersey City, New Jersey, United States Proclinical Staffing Full time

    Proclinical Staffing is seeking a seasoned Clinical Pharmacologist to drive strategic development in our biotech client's clinical programs. This leadership role offers the unique opportunity to collaborate with cross-functional teams and contribute to the growth of a dynamic biotech startup.Salary: The compensation package for this position includes an...