A clinical-stage biotechnology company based in San Francisco, backed by Third Rock Ventures, is harnessing the power of adipocyte biology and the latest advances in human genetics to develop first-in-class, next-generation medicines for cardiometabolic diseases. The company is building a pipeline of therapies that target rare and common cardiometabolic diseases. The company’s lead program is in Phase 2 clinical development for a number of cardiometabolic indications. This soon to launch company is led by a dynamic team of scientists and company builders with deep know-how and experience in cardiometabolic diseases, human genetics and adipocyte biology.Reporting the CMO, the Director/Senior Director, Clinical Development will be the clinical and medical strategic lead of one or more products/therapeutic areas, accountable for all applicable early and late clinical projects IND enabling through Ph2). The Clinical Development Director will ensure the planning, implementation, managing, and reporting of the applicable pre-clinical and clinical studies in accordance to the product development plan.The incumbent will have primary responsibility for providing product development status updates to the R&D Leadership Team. The incumbent will support Medical Affairs and R&D Operations teams with medical/clinical oversight and/or guidance on collaborative research programs applicable for one or products for which he/she is accountable.JOB RESPONSIBILITIES:Product DevelopmentLead and strategize the generation and implementation of product development plan (inclusive of target product profile, clinical development plan) for one or more productsProvide leadership for the R&D team members for the planning and execution of the pre-clinical and clinical programs in accordance with the product development plan (inclusive of target product profile, clinical development plan)Ensure that scientific rigor and innovation continues to be integrated into and drives Company’s development strategiesClinical Trials Guide and organize the team members for the planning, implementation, managing, and reporting of clinical trials and programsPrepare, review, and approve clinical trial content and documents including synopses and protocols, Investigator Brochures, and clinical study reportsReview and approve Medical Monitoring Plan, Safety Plans, Protocol Deviation PlansReview Statistical Analysis and long term strategy plan shellsEnsure studies are conducted according to GCPs and organizational SOPsContribute to the preparation of IND/NDA clinical sectionsServe as medical monitor and representative to multiple vendors and collaborators including CROs, PIs, core laboratories, and other organizations involved in the implementation of a clinical trialsWork closely with internal team and CRO in execution of trials, and provide ongoing guidance to CRO for protocol-specific clinical issues, site problems, and recruitment strategiesWork with R&D Operations and/or Finance on the clinical study budget and timelinesWork/Guide R&D and Regulatory teams on clinical/medical responses to regulatory agency queries, meetings preparations and review of briefing packagesReview/approve of clinical study entries (clinical trial information and results) for posting to www.clinicaltrials.gov and/or TPRsMay be expected to represent company at joint development committee as well with global regulatory agenciesClinical Study Publication Lead the creation, review and approval of abstracts, posters and manuscripts for pre-clinical/clinical studies in support of the publication strategies for assigned brandsStakeholder Management Provide product development status to Senior R&D Leadership TeamProvide sound clinical development guidance to key stakeholders across organizationBusiness Development Function as the Clinical Lead for business development activities by evaluating new product potentialSKILLS AND ABILITIES:Experience in pharmaceutical research, specifically exposure to the IND/NDA/BLA approval process, Phase 1 and 2 clinical researchThe incumbent should have an MD or MD/Ph.D and at least 5+ years of directly related biotechnology/pharmaceutical clinical research experienceThe incumbent must have demonstrated experience in clinical research, study trial management, clinical database maintenance, generation of research hypotheses, and publication and presentation of scientific informationProfessionalism, critical thinking, evidence-based reasoning, and a team-oriented outlook are of the utmost importanceProficiency in critical aspects of early and late development required for the job, specifically knowledge of the development path for the therapeutic areas, FDA and ICH regulations, GMP/GLP/GCPThis position also requires a working knowledge of software packages (e.g., MS Word, MS Excel, MS PowerPoint)The ability to work on a team and effectively communicate with a diverse audience are essentialExcellent communication (written and oral) skills are requiredDemonstrates the ability to analyze complex situations and proactively identify opportunities/issues; effectively solves problems that cross functional boundariesWORKING CONDITIONS: Prolonged periods of being at a stationary desk or work computerAbility to occasionally adjust, handle, or move objects up to 20 poundsAbility to assess the accuracy, neatness, and/or thoroughness of the work assignedWillingness and interest to work on site in our San Francisco office for a minimum of 3 days per weekWe do not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual’s status in any group or class protected by applicable federal, state, and local law. We invite applications from minorities, women, the disabled, protected veterans and all other qualified applicants.
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