Tbwa Chiat/Day Inc
Executive Director, Clinical Pharmacology Cambridge, Massachusetts, United State
Tbwa Chiat/Day Inc, Cambridge, Massachusetts, us, 02140
Executive Director, Clinical Pharmacology
Cambridge, Massachusetts, United StatesAbout Third Harmonic BioThird Harmonic Bio is a biopharmaceutical company with a singular purpose: To create a breakthrough treatment for people living with severe allergy and inflammation – debilitating conditions that can take a significant toll on overall health and well-being.We are developing a highly selective oral wild-type KIT inhibitor for millions of people living with chronic urticaria, severe asthma, and other mast cell-mediated diseases. Despite the availability of multiple approved medicines, there is an urgent need for new treatment options. We are grounded in our purpose of developing medicines to meaningfully improve the lives of the patients we serve.We are seeking smart, fun, and talented individuals seeking a fast-paced environment where they can meaningfully contribute to building a successful company.Our ValuesOur values provide the foundation for our culture and our operating principles – and underlie how we hold ourselves accountable and how we interact with each other, with our partners, and with the global medical and patient community.Be HumanRelationships are important. Bring your full self to work and create space for others to do the same. Balance candor with empathy.Own the Big PictureContext is critical. Ground every decision and action in the entirety of what we are trying to achieve.Go THRDWe hold ourselves to a higher standard. Work with urgency, purpose, and passion.The RoleReporting to the Chief, Nonclinical Development Officer, the
Executive Director, Clinical Pharmacology
will provide essential leadership in designing and directing all aspects of clinical pharmacology studies and strategy while ensuring alignment cross-functionally and with our external partners. This is an exciting time to join THRD to lead clinical pharmacology to advance new therapeutics for the treatment of mast cell-driven diseases.ResponsibilitiesDesign and drive model-informed drug development scientific activities to inform clinical pharmacology aspects of development plans.Align PK/PD project activities with both internal and external collaborators; including directing outsourced clinical pharmacology activities.Design, write and implement relevant sections of clinical protocols, provide input to clinical development plan and serve as member of Clinical Operations team.Actively participate in, and provide insight, in cross-functional team meetings (i.e., Clinical Operations and Project Teams).Gather and analyze PK data from clinical studies and provide guidance for future program strategy.Effectively communicate findings and interpret results of preclinical and clinical studies to drive the clinical pharmacology development plan objectives.Establish high compliance standards in the development and implementation of clinical pharmacology goals and deliverables.Develop in-house capabilities for model-based analysis in partnership with DMPK and Translational Sciences teams.Manage external relationships to drive work with vendors and CROs to write and approve sections of regulatory documents (i.e IND, CTA, etc) and regulatory interactions.Collaborate to prepare and co-author presentations and publications as appropriate.Minimum QualificationsPh.D. degree in Biology, Pharmacy or related field of science.15+ years of experience in Clinical Pharmacology in the Biotechnology, Pharmaceutical or CRO industry.Experience working with cross-functional teams to write and author scientific and regulatory documents and protocols.Experience supporting clinical development-stage programs with ability to serve as interface between preclinical and clinical disciplines.Experience in the drug development of small molecules is highly desirable including human dose predictions and design of clinical pharmacology programs.Global experience and understanding of regulatory environment and requirements.Effective written and oral communications skills.The approximate salary range for this role is $282,000-$312,000.All qualified applicants will receive consideration for employment without regard to race, sex color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.
#J-18808-Ljbffr
Cambridge, Massachusetts, United StatesAbout Third Harmonic BioThird Harmonic Bio is a biopharmaceutical company with a singular purpose: To create a breakthrough treatment for people living with severe allergy and inflammation – debilitating conditions that can take a significant toll on overall health and well-being.We are developing a highly selective oral wild-type KIT inhibitor for millions of people living with chronic urticaria, severe asthma, and other mast cell-mediated diseases. Despite the availability of multiple approved medicines, there is an urgent need for new treatment options. We are grounded in our purpose of developing medicines to meaningfully improve the lives of the patients we serve.We are seeking smart, fun, and talented individuals seeking a fast-paced environment where they can meaningfully contribute to building a successful company.Our ValuesOur values provide the foundation for our culture and our operating principles – and underlie how we hold ourselves accountable and how we interact with each other, with our partners, and with the global medical and patient community.Be HumanRelationships are important. Bring your full self to work and create space for others to do the same. Balance candor with empathy.Own the Big PictureContext is critical. Ground every decision and action in the entirety of what we are trying to achieve.Go THRDWe hold ourselves to a higher standard. Work with urgency, purpose, and passion.The RoleReporting to the Chief, Nonclinical Development Officer, the
Executive Director, Clinical Pharmacology
will provide essential leadership in designing and directing all aspects of clinical pharmacology studies and strategy while ensuring alignment cross-functionally and with our external partners. This is an exciting time to join THRD to lead clinical pharmacology to advance new therapeutics for the treatment of mast cell-driven diseases.ResponsibilitiesDesign and drive model-informed drug development scientific activities to inform clinical pharmacology aspects of development plans.Align PK/PD project activities with both internal and external collaborators; including directing outsourced clinical pharmacology activities.Design, write and implement relevant sections of clinical protocols, provide input to clinical development plan and serve as member of Clinical Operations team.Actively participate in, and provide insight, in cross-functional team meetings (i.e., Clinical Operations and Project Teams).Gather and analyze PK data from clinical studies and provide guidance for future program strategy.Effectively communicate findings and interpret results of preclinical and clinical studies to drive the clinical pharmacology development plan objectives.Establish high compliance standards in the development and implementation of clinical pharmacology goals and deliverables.Develop in-house capabilities for model-based analysis in partnership with DMPK and Translational Sciences teams.Manage external relationships to drive work with vendors and CROs to write and approve sections of regulatory documents (i.e IND, CTA, etc) and regulatory interactions.Collaborate to prepare and co-author presentations and publications as appropriate.Minimum QualificationsPh.D. degree in Biology, Pharmacy or related field of science.15+ years of experience in Clinical Pharmacology in the Biotechnology, Pharmaceutical or CRO industry.Experience working with cross-functional teams to write and author scientific and regulatory documents and protocols.Experience supporting clinical development-stage programs with ability to serve as interface between preclinical and clinical disciplines.Experience in the drug development of small molecules is highly desirable including human dose predictions and design of clinical pharmacology programs.Global experience and understanding of regulatory environment and requirements.Effective written and oral communications skills.The approximate salary range for this role is $282,000-$312,000.All qualified applicants will receive consideration for employment without regard to race, sex color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.
#J-18808-Ljbffr