What are the responsibilities and job description for the Sr. Director, Pharmacometrics position at Wave Life Sciences?
Wave Life Sciences is a biotechnology company focused on unlocking the broad potential of RNA medicines to transform human health. Our RNA medicines platform, PRISM, combines multiple modalities, chemistry innovation and deep insights in human genetics to deliver scientific breakthroughs that treat both rare and prevalent disorders. Our toolkit of RNA-targeting modalities includes editing, splicing, RNA interference and antisense silencing, providing us with unmatched capabilities for designing and sustainably delivering candidates that optimally address disease biology. Our diversified pipeline includes clinical programs in Duchenne muscular dystrophy, Alpha-1 antitrypsin deficiency and Huntington’s disease, as well as a preclinical program in obesity. Driven by the calling to “Reimagine Possible”, we are leading the charge toward a world in which human potential is no longer hindered by the burden of disease.
Description
Supporting Wave’s Oligonucleotide portfolio, you will be a senior scientific and strategic leader and a member of the Pre-Clinical and Development Sciences Leadership Team. In this key role, you will influence the discovery and development of drugs and expand the application of model-informed drug development (MIDD) approaches across all phases of drug development.
Experience
- PhD in Pharmaceutical Science, Math or related discipline or PharmD
- Strong quantitative experience (e.g., pharmacometrics, pharmacokinetics/pharmacodynamics, quantitative systems pharmacology, statistics)
- Minimum 10 years of pharmacometrics experience in a drug development setting
- Hands-on and proficient with pharmacometrics analysis and related software
- Experience writing pharmacometrics modeling results, interpretations (including impact) and conclusions for reports and regulatory documents
- Experience supporting pharmacometrics analyses for oligonucleotides preferred
Responsibilities
- Provide scientific, technical, and strategic leadership of the pharmacometrics function
- Provide oversight to the development of Model Informed Drug Development (MIDD) plans, involving planning and execution of quantitative analyses which may include system pharmacology approaches (QSP), physiologically based pharmacokinetics, population pharmacokinetics (PBPK), pharmacokinetics (PK)/pharmacodynamics (PD), exposure response, disease progression modeling
- Effectively partner with key stakeholders and colleagues in Discovery, Research, Clinical Pharmacology, Clinical Development, Regulatory, and Biometrics to accelerate non-clinical and clinical development strategies
- Train, develop, and mentor other MIDD colleagues
- Forecast pharmacometrics resourcing needs and manage consultants/CROs as needed
- Provide guidance to program’s regulatory MIDD strategy
- Contribute to the development or improvement of tools, processes and methodologies
Wave Life Sciences provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, Wave Life Sciences complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.
Wave Life Sciences expressly prohibits any form of workplace harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, or veteran status. Improper interference with the ability of Wave Life Sciences’ employees to perform their job duties may result in discipline up to and including discharge.
We value our relationships with professional recruitment firms. To protect the interests of all parties, and given the large volume of inquiries received from third-party placement agencies, we are not able to respond to all agency inquiries. We do not accept unsolicited resumes from any source other than directly from candidates for current or future positions. Submission of unsolicited resumes in advance of a signed agreement between our company and a placement agency does not create an implied obligation and, if an unsolicited candidate represented by a placement agency is hired, we are not obligated to pay a fee. Only approved recruitment firms will be allowed to provide services to Wave Life Sciences, USA.