Director, Quantitative Clinical Pharmacology: PK/PD Modeling & Strategy
$185.6k - $232kSarepta Therapeutics Inc
Why Sarepta? Why Now?The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold a leadership position in Duchenne muscular dystrophy (Duchenne) and are building a robust portfolio of programs across muscle, central nervous system, and cardiac diseases. In 2023, we launched our fourth therapy and the first ever gene therapy to treat Duchenne. We’re looking for people who see unlimited potential in themselves and who are motivated by an unwavering commitment to patients.What Sarepta Offers At Sarepta, we care deeply about all the people in our community and believe in the importance of supporting them in all aspects of their lives. We aspire to maintain a culture that acknowledges people bring their whole selves to work, and we will strive to help everyone in our community integrate their work and personal lives while maintaining productivity. We are committed to offering a range of benefits and work-life resources designed to support people in the following areas:Physical and Emotional WellnessFinancial WellnessSupport for CaregiversFor a full list of our comprehensive benefits, see our website: The Importance of the Role The Director of Quantitative & Clinical Pharmacology will be responsible to lead clinical pharmacology and pharmacometrics deliverables from early through late-stage clinical development (Ph3 and product registration), with an emphasis on clinical dose selection/refinement and predictive PK/PD modeling inclusive of population and statistically-based methodologies, as well as mechanistic and translational-focused approaches. This is a highly visible and team-facing role.The Opportunity to Make a Difference Drives the development and execution of the quantitative pharmacology strategies across all stages of drug development through product registrationLeads clinical pharmacology expertise in clinical and translational development strategies, protocol preparation, study execution, data review/analysis, study reportsResponsible for model-based data analyses including population PK, PK/PD modeling and simulation, meta-analysis, disease modeling to inform clinical developmentServes as functional lead for global regulatory strategies and HA engagementsMaintains leading-edge knowledge in clinical pharmacology and pharmacometrics discipline, publishes manuscripts, presents at scientific conferences and scientific forums.More about You PhD in Pharmaceutical Sciences, mathematics/engineering or related field with 7 years of experience working in clinical pharmacology or pharmacometricsStrong understanding of clinical pharmacology principles, strong hands-on experience with PK/PD modeling analysis, and experience in regulatory interactionsExcellent communication, multitasking, and collaboration skillsExperience in NONMEM & R highly preferred siRNA and/or CNS experience is preferred What Now? We’re always looking for solution-oriented, critical thinkers.So, if you’re comfortable with ambiguity and candor, relish challenging yourself, and place kindness and integrity at the forefront of how you approach your peers and work, then we encourage you to apply.#LI-HybridThis position is hybrid, you will be expected to work on site at one of Sarepta’s facilities in the United States and/or attend Company-sponsored in-person events from time to time.The targeted salary range for this position is $185,600 - $232,000 per year. Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges. The salary offer is commensurate with Sarepta’s compensation philosophy and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity.Candidates must be authorized to work in the U.S.Sarepta Therapeutics offers a competitive compensation and benefit package.Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.SummaryLocation: Cambridge, MA; Remote North Carolina; Remote New Jersey; Remote Virginia; Remote Maine; Remote Rhode Island; Remote Washington DC; Remote Florida; Remote New York; Remote Illinois; Remote Connecticut; Remote New HampshireType: Full time
$185.6k - $232k
...The Importance of the Role The Director of Quantitative & Clinical Pharmacology will be responsible to lead clinical... .../refinement and predictive PK/PD modeling inclusive of population and statistically... ...the quantitative pharmacology strategies across all stages of drug...SuggestedFull timeRemote work$177k - $278.08k
...you to shine? Join us as a Director, Quantitative Clinical Pharmacology Lead in our Cambridge, MA... ..., digital strategy, library sciences and data... ...DMPK). Enables impactful Model-Informed Drug Development... ...or independently performs PK, PD, and pharmacometric analyses...SuggestedMinimum wageFull timeWork experience placementWork at officeLocal areaRemote work$146.3k - $234.1k
...innovation. As Associate Director, Clinical Pharmacology & Pharmacometrics... ...(PK), pharmacodynamics (PD), and pharmacometrics... ...teams, you’ll drive strategies that shape the future... ...Drive PKPD modeling, exposure-response... ...and translational quantitative pharmacology activities...SuggestedHourly payWorldwide$174k - $196k
...Associate Director, Clinical Pharmacology Associate Director, Clinical... ...development strategy of our growing portfolio... ...pharmacokinetic (PK), pharmacodynamic (PD), exposure-... ...Lead and execute model-informed drug development... ...with quantitative scientists, to support...SuggestedWork at officeWork from homeFlexible hours$266k - $344k
...Beeline Medicines is a clinical-stage biotechnology company... ...: The Senior Director, Clinical Pharmacology provides clinical pharmacology... ...programs, directing PK/PD strategy, modeling and simulation, and... ...exposure-response, and other quantitative modeling efforts...SuggestedLocal areaFlexible hours2 days per week$130k - $200k
...translational nonclinical PK, PK/PD, ADME, clinical pharmacology and pharmacometrics in... ...selection, first-in-human strategy, dose selection and justification... ...and distribution, PK/PD modeling, exposureresponse... ...population PK, PBPK, and quantitative systems pharmacology where...Temporary workWork visa$275k - $285k
...Senior Director, Clinical Operations Cambridge, Massachusetts... ...clinical operations strategy and execution for assigned... ...spanning clinical pharmacology studies (first-in-human, SAD/MAD, PK/PD, drug-drug interaction... ...assessment, enrollment modeling, and scenario planning...Full timeContract workLocal area- ...Senior Director, Clinical Pharmacology Description Reporting to the SVP... ...aspects of the translational strategy, including pharmacokinetic (PK), toxicokinetic (TK) and pharmacodynamic (PD) assessments, biomarker... ...on experience with modeling and simulation based approaches...Work at office3 days per week
$210k - $300k
...Pharmaceuticals is seeking a Senior Director, Clinical Pharmacology with demonstrable... ...- and combination-therapy strategies to join our development... ...study designs, translational PK/PD predictions, and... ...justification. Develop and oversee model-informed drug development...Full timeWork at office- ...Description Communicates/presents key Clinical Pharmacology information/strategy to senior and executive management,... ...Leads Clinical Pharmacology/PK/PD activities and multiple major projects... ...knowledge of PK/PD data analysis, modeling and simulation methods and software...Full timeTemporary workLocal area
$150k - $195k
...Department: 107600 Clinical Pharmacology Location: San... ...The Associate Director, Clinical Pharmacology... ...clinical pharmacology strategies across Travere... ...pharmacokinetics (PK), pharmacodynamics (PD), and drug-drug interaction... ...escalation, PK/PD modeling) for early drug...Temporary workRemote workShift work$203.71k - $305.56k
...Are you an experienced clinical scientist who wants to... ...? Do you thrive where strategy meets day-to-day... ...us. We are seeking a Director, Clinical Scientist, Neuroimmunology... ...safety, efficacy, PK/PD, biomarkers, and... ...operations, clinical pharmacology, translational medicine...Hourly payTemporary workInterim role- ...Associate Director, Clinical Scientist How you'll make an impact: Serve as the study... ...to embed bioanalytical sampling (e.g., PK/PD, biomarker assays) into trial protocols... ...MSc, PharmD, MD, PhD) in Life Sciences, Pharmacology, or related field. ~4+ years in...
- ...communicates multi-disciplinary Clinical Pharmacology development plans and strategies that achieve commercial... .... Generates new PK/PD study proposals and leads... ...interpretation and discussion of model results in the context... ...: Associate Director, Clinical Pharmacology...Full timeLocal area
$236.25k - $393.75k
Job title: Senior Clinical Research DirectorLocation:... ..., MAClinical Research Director (Sr CRD) is the primary... ...select Exploratory Pharmacology studies) and/or registries... ...development plan strategies:Prepare documents and... ...work within a matrix model.International/ intercultural...Full time$219k - $235k
...Director of Clinical Operations The Director of Clinical Operations in... ...partner closely with Clinical Pharmacology, Translational Medicine,... ...resource planning, operational strategy, inspection readiness, eTMF... ...for the hybrid workplace model, requiring work to be completed...Work at officeLocal areaFlexible hours3 days per week$176.1k - $287.3k
...Associate Director of Pathology has primary... ...will also provide Clinical Pathology support... ...GLP toxicology and PK studies of Regeneron... ...teams to interpret pharmacologic and toxicity... ...Experience with animal models of human diseases... ...contribute to scientific strategy, problem solving,...Remote job$163.4k - $322.1k
...technologies, and formulate consumer-driven strategies to engineer a digitally enabled,... ...agenda including:o Marketing operating model and organizational designo Customer, patient... ..., or organizational effectivenessStrong quantitative and analytical skills, including the ability...Local areaFlexible hours- ...biomarker assays to support nonclinical and clinical studies. This role will lead the... ...relation to development and validation of PK, ADA and biomarker assays. This role requires... ...of use. The Role: Leadership and Strategy Develop and implement bioanalytical/...Work experience placement
$255k - $290k
...Senior Director, Clinical Development (Medical Director) City Therapeutics is a biotechnology... ...role in shaping clinical development strategy and translating innovative RNAi science... ...with Clinical Operations, Biometrics, Pharmacology, Toxicology, Regulatory Affairs, Translational...Full time$243.1k
...Moderna is seeking a senior level clinical development physician (M.D.)... ...clinical development strategy to support the creation and management... ..., regulatory, pre-clinical pharmacology, pharmaceutical sciences).... ...rest of world. Our Working Model As we build our company,...Permanent employmentFull timeWork at officeWork from home$90k - $95k
...our local communities. Your role as a Clinic Director will be central to our mission of... ...productivity and performance using data-driven strategies. Uphold compliance with relevant... ...records, medical terminology, and pharmacology. Excellent communication skills,...Local area$142.17k - $213.26k
...Are you a visionary expert in clinical drug development, possessing... ...to drive a successful strategy in accelerating the development... ...currently seeking an Associate Director Clinical Scientist,... ...clinical operations, clinical pharmacology, translational medicine, biostatistics...Hourly payTemporary work$216.1k - $360.2k
...diseases. We are seeking a Head of Clinical Trial Liaison to join our... ...-setting problems, directing strategy implementation for a broad,... ..., and own line management of Director, CTL Regional Heads. You will... ...Cambridge, MA, or Remote Work model/flexibility: Primarily on-...Remote workWorldwide$131k - $187k
...Senior Clinical Data Manager Repertoire Immune Medicines is a biotechnology company dedicated... ...practical data collection and review strategies. This is a role for someone who operates... ...and local laboratory, imaging, safety, PK/PD, biomarker, genomic, and specialty...Temporary workWork experience placementWork at officeLocal areaFlexible hours3 days per week- ...be responsible for overseeing clinical data management activities... ...is comfortable moving between strategy, execution, and problem-solving... ...as genomics, biomarkers, PK/PD, central imaging, and specialty... ...cannot. Monte Rosa’s QuEEN (Quantitative and Engineered Elimination of...
$190.8k - $300.3k
Job DescriptionThe Senior Director, Head of Clinical Development Learning & Center... ...vision, establishing the strategy, and directing the global... ...-leading digital and quantitative clinical science practices... ...effectiveness and integration lead to model and champion coaching as a...Full timeFor contractorsLocal areaFlexible hours$176.1k - $287.3k
...We're seeking an Associate Director to lead companion diagnostic (CDx) strategy and development, bridging translational... ...early biomarker feasibility through clinical validation, regulatory submission... ..., MA, Warren, NJ Work model/flexibility: 4 days onsite Discover...$171k - $236k
...Description Role Summary The Associate Director Clinical Scientist contributes to the execution... ...commercial, medical affairs, clinical pharmacology, translational medicine, and medical... ...Deciphera’s competitive total rewards strategy that also includes annual performance...$209.6k - $313.38k
...subsidiary exists the Global Clinical Development (GCD) department... ...research and preclinical pharmacology & toxicology into a streamlined... ...: Otsuka is seeking a Director, Global Clinical Development... ...agencies. Authors program strategies (i.e., GDCP) and oversees trials...Full timeTemporary workLocal areaRemote workWorldwideFlexible hoursWeekend work
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