Hello all, An exciting opportunity in a rapidly growing company.
Thanks Sridhar Company Overview Cerevel Therapeutics is a new biopharmaceutical company formed by Bain Capital and Pfizer that relentlessly finds paths through complexity to bring real progress and new treatment options to people living with neurological and neuropsychiatric disorders. Our portfolio of pre-commercial neuroscience assets targets a broad range of central nervous system (CNS) disorders including Parkinson’s, Alzheimer’s, epilepsy, schizophrenia and addiction. Headquartered in the Greater Boston area, we are bold thinkers, deep experts, resilient pathfinders, and transparent partners who push the boundaries of scientific understanding to unlock breakthrough CNS therapies that have real impact on people’s lives. Cerevel aspires to develop and nurture a culture characterized by respect, trust, curiosity, compassion with a relentless focus on mission and results. Our patient- centricity guides our purpose, how we treat each other and what we work on every day. The successful candidate will bring his/her own unique thinking and approach to Cerevel while sharing our core values and convictions. Role Summary In this highly visible, impactful role, this person will independently lead clinical pharmacology and modeling and simulation (M&S) activities to support Cerevel’s portfolio. You will have the opportunity to present clinical pharmacology plans, updates, and results to project teams and senior management. Key Responsibilities * Responsible for overall Clinical Pharmacology and M&S strategy to support Cerevel portfolio and other compounds in clinical development. * Lead all quantitative pharmacology activities to support both regulatory filings and internal decision-makings (e.g. Exposure-Response, QTc prolongation risk assessment, population PK/PD analysis) by working closely with internal colleagues (i.e. DMPK, toxicology, biology, clinical, statistics,) and external vendors * Independently formulate clinical pharmacology strategy to support regulatory submissions * Work in close partnership different partner lines to advance programs from Phase I to late-stage development * Responsible for designing and implementing dose finding strategies to ensure optimal dose and dosing regimens in clinical trials * Draft clinical pharmacology components of protocols, investigator's brochure and other regulatory documents * Oversee the design and protocol writing of clinical pharmacology studies (e.g. food effect, human ADME, drug interactions, QTc, renal and hepatic impairment) * Provide ad-hoc support to other programs as needed Required Qualifications * High-level of experience in Clinical Pharmacology with a demonstrated ability to implement pharmacometric principles in drug development * Strong understanding of clinical pharmacokinetic concepts * Hands-on modeling experience (i.e. NONMEM, R and Phoenix WinNonlin) * Regulatory filing experience * Working knowledge of DMPK and Toxicology * Effective verbal and written communication skills are essential for the role Preferred Qualifications * Neuroscience Experience is preferred Education * PhD in pharmacokinetics, pharmaceutical sciences, or a related field with 8+ years of experience Cerevel is an Equal Opportunity Employer and does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other characteristic protected by applicable law. Interested candidate, please apply at : https://jobs.lever.co/cerevel-2/c997652f-250b-4d5d-b082-b798769541c9