Role Summary:

The SVP, Head of Clinical Development will provide strategic direction and technical leadership to the clinical development team including clinical-regulatory development planning, clinical trial design, implementation and execution, clinical data analysis and management, and clinical competitive intelligence. This individual will provide strategic leadership for the clinical and medical aspects and will work closely with a cross-functional team to align the clinical development plan with the overall development strategy of the relevant products. The role is responsible for overseeing trials in clinical development and pharmacovigilance according to established timelines, for establishing and maintaining close working relationships with internal and external partners, and for providing the clinical regulatory landscape for each of the clinical programs. The Head of Development will act as a cross functional advisor and will work closely with the internal and/or external Clinical Development, Pharmacovigilance, biostatistics group(s), R&D, Regulatory, and the Commercial Development teams to execute clinical trial strategy and design.

This role is based in Waltham, MA without the possibility of being remote. 

Primary Responsibilities Include:

Design and oversee execution of multi-layered clinical development strategiesMaintain compliance with regulatory guidelines, that identify opportunities for breakthrough therapy designation and accelerated approval while identifying subsequent opportunities for label expansionInform global registration strategy by providing expert medical review, assessment, and interpretation of clinical data and preparing results for presentation to regulatory authoritiesManage drug safety and pharmacovigilance activities for ongoing trial(s)Prepare clinical portions of IND submissions and BLAs, including protocols and protocol amendments, investigator brochures, drug safety update reports, clinical study reports, medical reports, efficacy and safety summaries, scientific rationales and benefit/risk ratiosRapidly integrate new insights from on-going in-house or external clinical trials, translational science into development plans and clinical trial activitiesCreate compelling data presentations for external disclosuresCollaborate with research leadership and drug discovery teams to shape the company’s drug discovery portfolioDevelop and maintain key opinion leader relationships and serve as the clinical lead for advisory meetingsEstablish and maintain relationships with external companies (such as CROs), investigators and opinion leaders to optimize performance on clinical trial activitiesPrepare manuscripts for technical journals and make presentations at scientific meetingsWork collaboratively with Research to provide input into design of preclinical studies to support drug products entering or in the clinic and by helping initiate IND submissionsProvide input to evaluate products for in licensing/out licensingParticipate in business development processes as neededProvide clinical portion of regulatory documents such as Investigator Brochure updates, and Drug Safety Update ReportsManage and be responsible for pharmacovigilance for clinical projects including review and reporting with support from the pharmacovigilance teamProvide leadership and guidance for the clinical development team to ensure efficient execution to meet deliverables and timelinesOversee medical monitor activities for all phases of studies through direct execution of activities or supervision of a medical monitor

 Education and Skills Requirements:

PhD, PharmD, or MD required20+ years of progressive relevant experience within the biopharmaceutical/biotech industry in translational medicine/biology, clinical pharmacology or directly related discipline, preferably in the biopharmaceutical/biotech industryExperience in design and executing clinical trials; protocol development and design, development of case report forms, and statistical analysis plans; experience in rare disease drug development is preferredDemonstrated scientific and business acumen and the ability to influence senior leaders and stakeholders and lead complex partnership and alliance activitiesProvide clinical support and work with other members of the leadership team to develop and communicate the overall corporate strategyExperience in working closely with investigative sites, including principal investigators, sub-investigators, study coordinators, and other site personnel involved in clinical trialsStrong knowledge and experience across all phases of drug developmentLiaise with drug discovery, pharmacology, research and toxicology as necessary in order to finalize a pre-clinical program which will permit the most efficient clinical development of new chemical entities within the framework of the project teamPropose upon consultation with clinical operations pragmatic solutions to ensure the efficient ethical & quality conduct of clinical trialsExperience writing and reviewing clinical sections of study reports and regulatory documents (IND, BLA, MAA)Effective leadership, people management, communication skills and a team builder management style are essential; must be willing and able to be “hands on”Start-up/small company experience required, with willingness to be hands-onDemonstrated ability to manage multiple complex projects and programs simultaneouslyExcellent attention to details, critical thinking, and data interpretationStrong communication (oral and written) and interpersonal skillsExcellent organizational, multi-tasking and collaboration abilities



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