Associate Director / Director, Clinical Operations: Pharmacology and Biomarker Development

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    "description": "<p><span style=\"font-weight: bold\">Associate Director / Director, Clinical Operations: Pharmacology and Biomarker Development - Hummingbird Bioscience</span></p>\n<p>Full-time position – Singapore (SG) based location</p>\n<p> </p>\n<p><span style=\"font-weight: bold\">ABOUT HUMMINGBIRD BIOSCIENCE</span></p>\n<p>Hummingbird Bioscience is a biotherapeutics company working at the interface of artificial intelligence and human innovation to discover and develop transformative medicines for hard-to-treat diseases. Hummingbird Bioscience’s computational and systems biology technologies have generated a pipeline of innovative clinical-stage monoclonal antibodies and antibody-drug conjugates in oncology and autoimmunity.  At Hummingbird Bioscience, the commitment to rigorous science, teamwork, and intellectual integrity underpins our passion to accelerate the journey of new drugs from concept to clinic.</p>\n<p> </p>\n<p>For more information, please visit <a href=\"https://www.hummingbirdbioscience.com/\" target=\"_blank\" rel=\"noopener noreferrer\">www.hummingbirdbioscience.com</a>, and follow Hummingbird Bioscience on <a href=\"https://www.linkedin.com/company/hummingbird-bioscience\" target=\"_blank\" rel=\"noopener noreferrer\">LinkedIn</a>, <a href=\"https://twitter.com/hummingbirdbio\" target=\"_blank\" rel=\"noopener noreferrer\">X (formerly Twitter)</a>, and <a href=\"https://www.youtube.com/@hummingbirdbioscience\" target=\"_blank\" rel=\"noopener noreferrer\">YouTube</a>.</p>\n<p> </p>\n<p><span style=\"font-weight: bold\">ABOUT THE ROLE</span></p>\n<p>Reporting to the VP of Clinical Operations and Program Management, the Assoc. Director / Director of Clinical Operations: Pharmacology and Biomarker Development (Clinpharm) will provide strategic and operational leadership across our pipeline, with a primary focus on clinical pharmacology and biomarker development and implementation in ongoing and planned clinical development. This individual will play a key role in bridging pre-clinical and clinical development, ensuring that drug candidates are advanced with robust scientific rationale, translational insights, and regulatory readiness.</p>\n<p>  </p>\n<p><span style=\"font-weight: bold\">KEY RESPONSIBILITIES</span><br></p>\n<p><br><br></p>\n<ul>\n<li>Lead clinical pharmacology strategy and execution, including PK and ADA method development, PK/PD modelling, clinical sample analysis, dose justification, safety margin assessment, and strategies for patient stratification or dose adjustment</li>\n<li>Work with CROs, laboratories, and—where needed—specialized consultants to lead the design, development, qualification, validation, and scientific oversight of PK and ADA assays, ensuring high-quality execution and robust data interpretation<span style=\"font-weight: bold\">.</span></li>\n<li>Incorporate quantitative endpoints and modelling approaches (PK/PD, exposure–response, biomarker-based) into clinical studies to demonstrate target engagement and pharmacologic mechanism</li>\n<li>Provide strategic oversight and recommendations on endpoints, study design, safety evaluations, and dose selection across clinical-stage assets</li>\n<li>Collaborate with biostatisticians to ensure high-quality data analysis, interpretation, and reporting to support internal decision-making</li>\n<li>Support clinical document preparation, including drafting PK/ADA and exploratory pharmacodynamic assessment plans for clinical protocols</li>\n<li>Alongside the research team, assist in developing and operationalization of biomarker strategies for patient selection, exploratory pharmacodynamic assessments, mechanism-of-action readouts, and regulatory submissions</li>\n<li>Contribute to regulatory submissions (draft/review relevant sections for IND, CTA, NDA/BLA)</li>\n<li>Partner with the Clinical Operations team to ensure clinical site readiness for PK, ADA, and biomarker analysis, sample management and data reconciliation</li>\n<li>Collaborate with the Bioinformatics team to support PK/ADA analyses</li>\n<li>Prepare and review PK, ADA and biomarker presentation materials for external stakeholders</li>\n<li>Maintain clear and consistent communication with senior management on clinical pharmacology and translational deliverables, risks, and timelines</li>\n</ul>\n<p><br><br></p>\n<p><span style=\"font-weight: bold\">QUALIFICATIONS </span></p>\n<ul>\n<li><span style=\"font-weight: bold\">Education:</span>\n<ul>\n<li>Advanced scientific degree in molecular or cancer biology, or a similar field (Ph.D., Pharm.D., M.D.)</li>\n</ul>\n</li>\n<li><span style=\"font-weight: bold\">Experience and skills </span>\n<ul>\n<li><br>8+ years of relevant industry experience in Clinical Pharmacology with 4+ years in a leadership role driving strategy and execution.</li>\n<li>Antibody experience strongly preferred; additional experience with biologics including ADC, TCE, immunotherapies, or targeted oncology agents is advantageous</li>\n<li>Demonstrated expertise in clinical pharmacology, including PK/PD modeling, dose selection/justification, safety margin assessment, and immunogenicity/ADA evaluation</li>\n<li>Experience in translational medicine and biomarker development (desirable)</li>\n<li>Strong track record of developing and implementing biomarker strategies, including assay development, validation, and incorporation into clinical trials for patient selection and pharmacodynamic assessments</li>\n<li>Direct experience with regulatory submissions (IND, CTA, NDA/BLA) and participation in health authority interactions</li>\n<li>Proven ability to work effectively with cross-functional teams (clinical development, regulatory, clinical operations, biostatistics, discovery research, and program management)</li>\n<li>Excellent strategic thinking skills with ability to translate complex scientific insights into actionable development decisions.</li>\n<li>Outstanding written and verbal communication skills</li>\n<li>Strong organizational and project management skills, with demonstrated success managing multiple programs and priorities in fast-paced environments</li>\n<li>Commitment to mentorship and team development, fostering a collaborative and high-performance culture</li>\n</ul>\n</li>\n</ul>\n<p> </p>\n<p><span style=\"font-weight: bold\">OUR MISSION &amp; VALUES</span></p>\n<p>Our fast-growing biotechnology company is committed to discovering and developing important new drugs for cancer and autoimmune diseases, and living by our values: Excellence, Determination, Teamwork, Intellectual Integrity and Audacity.</p>\n<p> </p>\n<p><span style=\"font-weight: bold\">JOIN US AT THE FRONTIER OF DRUG DISCOVERY AND DEVELOPMENT</span></p>\n<p>We are looking for passionate and motivated individuals committed to solving important, complex problems. We are committed to the personal and professional development of our team and offer robust learning and development programs. Hummingbird Bioscience understands the need for flexibility for our team and offers a generous paid time off program with flexibility to support employees through different life stages. We invest in our team’s health by offering competitive benefits including health and dental insurance, and a comprehensive and holistic employee assistance program. We foster a more collaborative, productive, and sociable culture with on-site lunches and snacks. Finally, we believe in creating social impact beyond our business through corporate social responsibility initiatives.</p>\n<p> </p>\n<p>Are you ready to join us on our mission to discover and develop important new drugs for cancer and autoimmune disease? Click on ‘Apply for this Job’ to submit your application.</p>\n<p><br><br></p>\n<p>For further enquiries, please email us at <a href=\"mailto:[email protected]\" target=\"_blank\" rel=\"noopener noreferrer\"><span style=\"font-weight: bold\">[email protected]</span></a>.</p>\n<p> </p>\n<p><em>Hummingbird Bioscience is firmly committed to Equal Employment Opportunity (EEO) and to compliance with all Singapore and US federal, state and local laws and/or guidelines that prohibit employment discrimination on the basis of age, race, color, gender, sexual orientation, gender identity, ethnicity, national origin, citizenship, religion, genetic carrier status, disability, pregnancy, childbirth or related medical conditions, marital status, protected veteran status and other protected classifications.</em></p>",
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