Senior Director, Clinical Pharmacology

Senior Director, Clinical PharmacologyReporting to the SVP of Research, the Senior Director, Clinical Pharmacology will drive all aspects of the translational strategy, including pharmacokinetic (PK), toxicokinetic (TK) and pharmacodynamic (PD) assessments, biomarker development and biodistribution studies, and will be accountable for delivering key translational milestones from candidate selection to BLA.This role may be based in their Waltham, MA or Boulder, CO office. Their office-based employees are required to work in the office three (3) days a week.ResponsibilitiesScientific oversight for translational BLA and IND enabling studies, including exploratory and GLP PK/TK studies, PD and biomarker development, biodistribution studies, and development of reagents and assays for Anti-Drug Antibody (ADA) assessmentEnsure compliance with regulatory requirements and industry standards for translational and clinical pharmacology related research activitiesMentor and develop a high-performing translational science team, fostering a culture of innovation and scientific rigorManage CROs and translational scientists that will be interfacing with Research and Development groups as new therapies are advancedEnsure appropriate scientific rigor in the design, conduct, validity and interpretation of non-clinical data to support clinical programs and regulatory applicationsAuthor and review PK, TK, PD, ADA and associated translational study reports in support of regulatory submissionsClosely collaborate with clinical development to conduct translational components of planned clinical studiesContribute to the design execution of program translational strategies integrating both disease and pathway approachesSupport execution of early and late clinical trials through BLA submissionResponsible for the strategic planning, authoring, and review of the translational biology components of regulatory documents, scientific data and publicationsIdentify significant issues and risks that may impact overall project plans and initiate contingency plans as appropriateContribute to departmental resource planning, budgeting and timeline setting to meet company needsManage CROs conducting translational studiesContribute to scientific and clinical interface with key opinion leaders (KOL), facilitating KOL advocacy developmentMay provide line management, oversight and coaching to more junior research/clinical staffRepresent Research and Translational Science for project teams when presenting project and governance meetingsLead or participate in cross-functional working groups such as scientific and safety review boardsIdentify and collaborate with academic investigators to optimize the translational strategy and plans for programsResponsible for presentation of results and updates of projects at department, project, corporate and scientific meetingsRequirementsRequires a PhD degree with a minimum of 12+ years of combined academic and biotechnology or pharmaceutical experience in Clinical Research, Clinical Pharmacology, and/or Translational Sciences, including experience with therapeutic antibodiesPrior experience in translational science with in-depth knowledge of PK, TK, and PD principles, biomarker development, and biodistribution studies, as well as a significant publication track record supporting this experienceDeep understanding of and direct clinical experience in immunology, inflammation, and/or endocrinology, in both early and late stages of developmentHands on experience with modeling and simulation based approaches, including population based PK modeling, exposure response modeling, and model based dose selection.Strong understanding of the regulatory requirements for translational research, drug development and submission activitiesBroad and deep understanding of approved and investigational therapies for these disease areasAbility to effectively present ideas and document complex medical/clinical concepts in both written and oral communicationPrior industry experience in the preparation of clinical protocols, study reports, IND, IB, BLA/CTD documentsKnowledge of GCPs, ICH guidelines and FDA regulations and familiarity with EMA/CHMP regulations and guidelines, and other international regulatory requirementsDemonstrated ability as a scientific and or medical expert in a complex matrix environmentGeneral familiarity with biostatistics and/or pharmacometrics; expert in navigating scientific literature, interpretation of data, display of dataDemonstrated problem solving skills (including taking ownership to ensure timely resolution), a strong sense of urgency, keen attention to detail, and the ability to successfully execute in an environment under time and resource pressuresAbility to work well in a fast paced, innovative and performance driven environmentDemonstrated ability to integrate scientific rationale, target biology, clinical strategy, and target product profile to develop appropriate translational strategiesDemonstrated ability to simultaneously work on complex projects requiring an in-depth evaluation of multiple, interdependent factorsAbility to prioritize responsibilities and meet deadlinesAbility to self-motivate and work independentlyAttention to detail, experience in monitoring work to assure quality, accuracy and thoroughnessOutstanding communication skills with the ability to effectively converse with a variety of audiences including team members, cross-functional project teams, project leaders, KOLs and senior managementDemonstrated ability to think strategically and solve complex scientific problems, as well as ability to work at the strategic and tactical levelDemonstrated ability to contribute successfully in a multi-disciplinary team environment while serving as a team leadExcellent problem-solving abilities with a focus on accomplishing company goals and objectives in a dynamic business environmentStrong focus and drive to succeedComfortable challenging the status quo and bringing forward innovative solutionsStrong commitment to ethical standardsProficient with Microsoft Office suite (i.e., Word, PowerPoint, Excel, Outlook, SharePoint, etc.), as well PK modeling software (Phoenix, R, or NONMEM).Ability to travel up to 20%The salary range for this position is commensurate with experience