Senior Medical Director, Clinical Development

4 weeks ago


Waltham, United States DynamiCure Biotechnology Full time

Senior Medical Director, Clinical DevelopmentSenior Medical Director, Clinical Development1 year ago Be among the first 25 applicantsDynamiCure is seeking a talented, independent, and motivated clinician to help build our clinical development group. You will join a small but growing clinical development group contributing to the medical function, including designing, implementing, and communicating global clinical development plans for our vascular normalization and tumor microenvironment programs. You will serve as an internal and external clinical leader, including interactions with key academic advisors, principal investigators, patient groups, regulatory authorities, academic and industry collaborators as well as DynamiCure’s senior management and Board of Directors.As a key contributor you will be a thought partner with the VP of Clinical Development for innovative oncology development strategies, as well as a collaborator with discovery, preclinical and translational researchers focused on development of novel vascular normalization and TME modulators.Reports to: VP, Clinical DevelopmentTravel expectations: 20%Key Responsibilities And ActivitiesProvide oncology drug development expertise to an expanding oncology portfolio, all developed and discovered within DynamiCureProvide sound clinical development guidance to key stakeholders across DynamiCureEnsure that scientific rigor and innovation continues to be integrated into and drives DynamiCure’s oncology development strategiesExcellent scientific standing among peers and the ability to address issues with a very high level of scientific rigor and creative solutionsAdeptly translate oncology development program strategies into clinical study concepts that can be executed without compromising the scientific rigor of the studyAssist in driving the timely execution of multiple assets and studies within the oncology portfolioEnsure excellence in both strategy and execution by partnering closely with clinical operations, biostatistics, data management, program management, and research colleaguesWork closely with regulatory leaders to support regulatory submissions and develop regulatory strategiesResponsible for the clinical content of clinical and regulatory documents, including protocols, INDs, CTAs, investigator brochures, CRF’s, annual IND reports, CSR’s, ISS’s, ISE’s, and clinical expert reportsServe as Medical Monitor and the Sponsor’s medical representative to multiple vendors and collaborators: CROs, PIs, core laboratories and other organizations involved in the implementation of clinical trialsResponsible for analysis of clinical data, including safety monitoring in collaboration with PVDevelop and maintain relationships and serve as medical liaison with key opinion leaders and PIsOrganize and present at relevant clinical advisory boards, DMC’s and medical/scientific meetingsDemonstrated capability to lead cross-functional teamsAble to provide leadership and mentor more junior members of the clinical development teamAble to present DynamiCure programs to external parties and contribute as needed to business development effortsRequired Education, Experience, Skills, And CompetenciesM.D. or D.O. degree and clinical oncology experience required & at least 5 years’ experience working in the biotech and/or pharmaceutical industry; board certification/eligibility in oncology and MD/PhD are strongly preferred.Hands-on oncology or I/O drug development experience within industry oncology in pharmaceutical and/or biotech company setting either for small molecules or large moleculesProven clinical development strategist with hands-on experience with designing, implementing, and conducting clinical trials.Knowledge of carrying out oncology clinical trials, including knowledge of current treatment landscapes.Strategic leadership and tactical skills, excellent initiative, and judgment, and demonstrated ability to positively represent the goals of DynamiCureDemonstrated ability to develop and maintain excellent working relationships with both internal colleagues and external contacts, including key thought leaders, and investigatorsProven track record of strong collaboration skills and the ability to partner with others to implement innovative oncology development strategiesAbility to communicate and work independently with scientific/technical personnel with excellent oral presentation skillsAbility to think critically and demonstrated troubleshooting and problem-solving skillsComfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing prioritiesWhy Work for DynamiCureAround the Office:Flexible scheduling around core hoursCasual dress codeUnlimited drinks & snacksBenefits:20 days Paid Time Off10 paid holidays plus Winter BreakPaid Family LeaveFull benefits package including:MedicalDentalVisionHSA Account with Company contribution401(K) with up to 5% matchCompany paid life and AD&D insuranceSupplemental life & AD&D insuranceCompany paid short- and long-term disability insuranceEmployee Assistance ProgramEmployee Programs:Employee Referral ProgramEmployee Assistance ProgramWe are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, creed, national origin, ancestry, sex, age, handicap or disability, marital status, sexual orientation, gender identity or expression, pregnancy or pregnancy-related condition, genetic information, veteran status, immigration or citizenship status, military obligations, status as a domestic violence victim or a victim of sexual assault or stalking, participation in discrimination complaint-related activities, or any other status protected under applicable federal, state or local law.Powered by JazzHROW5DGHX2o8Seniority levelSeniority levelMid-Senior levelEmployment typeEmployment typeFull-timeJob functionJob functionHealth Care ProviderIndustriesInternet PublishingReferrals increase your chances of interviewing at DynamiCure Biotechnology by 2xGet notified about new Senior Medical Director jobs in Waltham, MA.Sr. Director Global Quality Assurance (GLP/GCP)Boston, MA $200,000.00-$300,000.00 1 month agoHead (Executive Director) Rare Disease, US Medical AffairsCambridge, MA $296,000.00-$418,000.00 3 weeks agoAssociate Medical Director of Clinical DevelopmentCambridge, MA $201,000.00-$290,333.33 2 days agoSenior Medical Director, Pharmacovigilance and SafetyBoston, MA $330,000.00-$380,000.00 1 month agoExecutive Director Medical Affairs, Operations and Strategic ExcellenceSenior Medical Director, Clinical DevelopmentGreater Boston $175,000.00-$230,000.00 2 weeks agoCambridge, MA $228,900.00-$359,700.00 5 days agoDirector/Sr. Director, Clinical DevelopmentExecutive Director/VP, Clinical DevelopmentWaltham, MA $290,000.00-$330,000.00 1 week agoSenior Director, Clinical Operations/DevelopmentSenior Director, Medical Writing (Hybrid)Boston, MA $219,200.00-$328,800.00 2 days agoWe’re unlocking community knowledge in a new way. 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