Cytokinetics is a late-stage, specialty cardiovascular biopharmaceutical company focused on discovering, developing and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which cardiac muscle performance is compromised. As a leader in muscle biology and the mechanics of muscle performance, the company is developing small molecule drug candidates specifically engineered to impact myocardial muscle function and contractility.
As the Senior Scientist II DMPK, you will support and lead nonclinical development DMPK activities to support progression of muscle directed potential treatment for diseases characterized by compromised muscle function, muscle weakness, and fatigue. You will collaborate closely with IND enabling project teams; develop and execute DMPK and PKPD strategies necessary to optimize and facilitate the advancement of muscle-directed small molecules into Clinical Development.
Responsibilities
- Lead the formulation and execution of comprehensive DMPK and pharmacokinetics-pharmacodynamics (PKPD) strategies to steer lead optimization and developmental projects, ensuring alignment with project objectives, milestones, and progression of development candidates
- Act as the primary DMPK and bioanalytical representative within project teams, contributing expertise to the advancement of innovative drug candidates, encompassing both small molecules and potentially large molecules such as PROTACs, targeted at addressing Cardiovascular and Skeletal Muscle diseases
- Employ sophisticated analysis and synthesis techniques to integrate in silico, physicochemical, ADME, and DMPK data, with a keen focus on understanding the intricate dynamics of drug metabolism and potential drug-drug interactions, thereby informing molecule design and selection processes
- Collaborate seamlessly with cross-functional project team members spanning Biology, Chemistry, translational Pharmacology, toxicology, and Regulatory affairs, facilitating the generation of pertinent DMPK data essential for informed decision-making, including target validation, biomarker selection, and candidate progression
- Engage actively in partnership with key stakeholders to contribute to the development of robust PK/PD models, aimed at furnishing critical insights and data supporting effective translational and biomarker strategies
- Lead the coordination and oversight of Drug Metabolism, PK, and PKPD studies, encompassing the solicitation of bioanalytical support
- Contribute to the preparation of Drug Metabolism, PK, and PKPD reports, including active involvement in report writing, review, and preparation, with a particular emphasis on crafting DMPK-BA sections of regulatory documents such as Investigational New Drug (IND), New Drug Application (NDA), and Biologics License Application (BLA), as well as providing comprehensive responses to regulatory inquiries, thereby ensuring the generation of high-quality reports aligned with regulatory standards and expectations
Qualifications
- Doctorate (PhD) with 8+ years of experience Pharmaceutical Sciences or related field
- In-vivo and in-vitro drug metabolism including mass balance, stability evaluation, structural elucidation, enzymology, drug-drug interaction (DDI), metabolic enzyme inhibition and induction
- Experience conducting and implementing bioanalysis (BA) methodology in the ADME, PK and PD areas (regulated and non-regulated)
- Proficiency in applying pharmacokinetic (PK) principles to both noncompartmental and compartmental analysis within PK/TK/PD studies
- Proficient understanding and application of cytochrome enzyme inhibition, induction, drug transporter functionality, and their effects on pharmacokinetics (PK) and drug-drug interactions (DDI)
- Expertise in in-vitro - in-vivo extrapolations (IVIVE) and allometric principles, with a focus on utilizing these methods for accurate predictions of first-in-human dose and exposure
- Knowledgeable of current regulatory landscape in DMPK area of expertise including contribution to regulatory filings (IND, NDA, investigator brochure)
Actual salary at the time of hire may vary and may be above or below the range based on various factors, including, but not limited to, the candidate’s relevant qualifications, skills, and experience, as well as the service line and location where this position may be filled.
Our employees come from different backgrounds, and we celebrate those differences. We are looking for the best candidates for our open roles, but do not expect applicants to meet every qualification in order to be considered. If you are excited about what you could accomplish at Cytokinetics and believe you can add value to our team, we would love to hear from you.
Please review our General Data Protection Regulation (GDPR) policy PRIOR to applying.
Our passion is anchored in robust scientific thinking, grounded in integrity and critical thinking. We keep the patient front and center in all we do – all actions and decisions are in service of the patient and their caregivers. We champion integrity, ethics, doing the right thing, and being our best selves.
Please visit our website at: www.cytokinetics.com
Cytokinetics is an Equal Opportunity Employer
