Clinical Development Director Jobs

Job Title: Lead - Aggregate Reporting Employment Type: Full-time Work Type: Remote About ClinChoice: ClinChoice is a partner to the largest pharmaceutical, medical device, and consumer care innovators in the world. Established in 1995, we provide expertise in clinical operations, biometrics, regulatory affairs, pharmacovigilance, medical affairs, and toxicology to help our partners advance healthcare by accelerating clinical trials with data-driven insights, delivering the best strategies for product registration, and enhancing patient safety through real-world and clinical analysis. Our global delivery network has expanded to centers and satellite offices in the United States, Mexico, the United Kingdom, Armenia, China, Japan, India, and the Philippines to help our customers maintain regulatory compliance locally and globally. We have forged future-defining partnerships with industry bodies and technology companies to develop cutting-edge solutions that deliver our expertise with quality and precision. Primary Responsibilities: Responsible for authoring Aggregate Safety Reports (including but not limited to PBRER/PSUR, ACO, DSUR, PADER, CAR, RMP, Ad-hoc safety reports for medicinal and non-medicinal products and EU-MDR PSUR, PMSR, PMSP, and PRER reports for medical devices, and Cosmetovigilance reports for Cosmetic products for submissions to various health authorities as per the requirement). Plan report-specific timelines, identify relevant stakeholders, request calls for contributions, and coordinate with various stakeholders for obtaining relevant data for the preparation of aggregate safety reports. Review the safety data (including the seriousness and expectedness assessments of events, as may be necessary) as per the agreed strategy and sponsor’s conventions and verify the correctness and completeness of contributions received from stakeholders. Perform aggregate review of post-marketing cases received in global databases and assess whether the cases alter t

Job Description Job Title: Senior Executive / Specialist - Case Processing E mployment Type: Contract Location: Brazil (Remote) A bout ClinChoice ClinChoice is a partner to the largest pharmaceutical, medical device, and consumer care innovators in the world. Established in 1995, we provide expertise in clinical operations, biometrics, regulatory affairs, pharmacovigilance, medical affairs, and toxicology to help our partners advance healthcare by accelerating clinical trials with data-driven insights, delivering the best strategies for product registration, and enhancing patient safety through real-world and clinical analysis. Our global delivery network has expanded to centers and satellite offices in the United States, Mexico, United Kingdom, Armenia, China, Japan, India, and the Philippines to help our customers maintain regulatory compliance locally and globally. We have forged future-defining partnerships with industry bodies and technology companies to develop cutting-edge solutions that deliver our expertise with quality and precision. Primary Responsibilities: Experience in Intake/Triage, Data Entry, Quality Review, Case Finalization/Distribution of cases received from sources such as Spontaneous, Literature, Regulatory Authority, Solicited and Clinical trials. Experience in raising follow-up queries, as necessary, with appropriate documentation in the safety database. Experience in ARGUS database. Experience in rare disease portfolio. Must possess thorough knowledge of ICH-GCP, relevant GVP module, 21 CFR guidelines and other regulatory requirements. Training and mentoring skill (ICSR, Safety database etc.). Candidate Profile: Bachelor’s or Master’s in Pharmacy / Life Sciences or above and in alignment with project / business team requirements. Minimum of 3 to 5 years of relevant experience in identified functional domain/ business workstream. Must have hands on experience with MS office applications (Outlook, Excel, Word, Power Point

Responsibilities: Annotate Case Report Form (acrf.pdf) following FDA/CDISC or sponsor guidelines. Develop SDTM specifications and generate SDTM datasets using SAS; Develop ADaM,specifications and generate ADaM datasets using SAS based on Statistical Analysis Plan; Develop Tables, Listings, Graphs, Patient Profile in support of the Clinical Study Report, Posters, Manuscripts; Develop ADaM data, Tables, Listings, Figures for Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE) Create electronic submission packages to FDA, e.g., define.xml or define.pdf following FDA guidelines with no supervision. Expert-level in analyze information and develop innovative solutions to programming and data analysis challenges; Serve as point of contact (POC) of programming with statisticians for statistical input and analysis interpretation; Follow and reinforce regulatory agency requirements during daily job. Serve as a programming team lead and contribute to department initiatives. Provide guidance, mentoring, training for team members and help solve issues from cross-functional teams; Review draft and final production deliverables for project to ensure quality and consistency. Work with global team or sponsors to coordinate project deliverables, timelines and resources. Skills and Responsibilities: Bachelor’s/Master’s degree in Statistics, Mathematics, Computer Science, Electrical Engineering, Biotechnology or related scientific disciplines with 5+years of clinical programming experience. Proven knowledge and training in high level computing languages such as. SAS, C/C++, Java, R, Python, MATLAB and SQL. Database programming experience is a plus. Expert-level in decoding programming logic and assembling programming code based on logic provided and be able to explain to team members. Expert level in applying concept in Artificial Intelligence and Machine Learning in real world. In-depth knowledge of ICH, Good Clinical Practices, Clinical research, Clinical tria

Responsibilities: Annotate Case Report Form (acrf.pdf) following FDA/CDISC or sponsor guidelines. Develop SDTM specifications and generate SDTM datasets using SAS. Develop ADaM specifications and generate ADaM datasets using SAS based on Statistical Analysis Plan. Develop Tables, Listings, Graphs, Patient Profile in support of the Clinical Study Report, Posters, Manuscripts. Develop ADaM data, Tables, Listings, Figures for Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE). Create electronic submission package to FDA, e.g., define.xml or define.pdf following FDA guidelines with minimum supervision. Proficient in analyze information and develop innovative solutions to programming and data analysis challenges; Support the point of contact (POC) of programming with statisticians for statistical input and analysis interpretation Follow and reinforce regulatory agency requirements during daily job. Serve as a programming team lead and contribute to department initiative. Provide guidance, mentoring, training for team members and help solve issues from cross-functional teams. Review draft and final production deliverables for project to ensure quality and consistency. Skills and Qualifications: Bachelor’s/Master’s degree in Statistics, Mathematics, Computer Science, Electrical Engineering, Biotechnology or related scientific disciplines with at least 4+ years of clinical programming experience. Proven knowledge and training in high level computing languages such as. SAS, C/C++, Java, R, Python, MATLAB and SQL. Database programming experience is a plus. Proficient in decoding programming logic and assembling programming code based on logic provided and be able to explain to team members. Proficient in applying concepts in Artificial Intelligence and Machine Learning in the real world. In-depth knowledge of ICH, Good Clinical Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology. Good understa

About Us SharkNinja is a global product design and technology company, with a diversified portfolio of 5-star rated lifestyle solutions that positively impact people’s lives in homes around the world. Powered by two trusted, global brands, Shark and Ninja , the company has a proven track record of bringing disruptive innovation to market and developing one consumer product after another has allowed SharkNinja to enter multiple product categories, driving significant growth and market share gains. Headquartered in Needham, Massachusetts with more than 4,100 associates, the company’s products are sold at key retailers, online and offline, and through distributors around the world. AI at SharkNinja At SharkNinja, we’re building an AI-native culture. We’re not waiting for the future; we’re creating it. Our people are expected to experiment boldly, adopt new tools, and continuously raise what’s possible to create meaningful impact for our consumers. If you believe the best way to do your job hasn’t been invented yet, you’ll fit right in. *]:pointer-events-auto R6Vx5W_threadScrollVars scroll-mb-[calc(var(--scroll-root-safe-area-inset-bottom,0px)+var(--thread-response-height))] scroll-mt-[calc(var(--header-height)+min(200px,max(70px,20svh)))]" data-turn-id="request-WEB:0dac30de-3b8c-4fad-bd4f-c3d5acffeb44-0" data-turn-id-container="request-WEB:0dac30de-3b8c-4fad-bd4f-c3d5acffeb44-0" data-testid="conversation-turn-2" data-turn="assistant"> Notre mission, qui consiste à améliorer chaque jour la vie des gens dans les foyers du monde entier, permet à nos employés de réfléchir, d’expérimenter, de concevoir, de passer à l’action, de créer et d’analyser pour donner vie à des produits qui les passionnent. Dans le cadre de notre croissance, nous sommes ravis d’accueillir un chef d’équipe, Opérations de vente au détail , au sein de notre équipe. APERÇU DU POSTE Le chef d’équipe, Opérations de vente au détail , dirige u

About Us SharkNinja is a global product design and technology company, with a diversified portfolio of 5-star rated lifestyle solutions that positively impact people’s lives in homes around the world. Powered by two trusted, global brands, Shark and Ninja , the company has a proven track record of bringing disruptive innovation to market and developing one consumer product after another has allowed SharkNinja to enter multiple product categories, driving significant growth and market share gains. Headquartered in Needham, Massachusetts with more than 4,100 associates, the company’s products are sold at key retailers, online and offline, and through distributors around the world. AI at SharkNinja At SharkNinja, we’re building an AI-native culture. We’re not waiting for the future; we’re creating it. Our people are expected to experiment boldly, adopt new tools, and continuously raise what’s possible to create meaningful impact for our consumers. If you believe the best way to do your job hasn’t been invented yet, you’ll fit right in. We are open to candidates in the Montreal or Mississauga area. Spécialiste, Médias sociaux payants – Marketing de performance DTC À propos de nous SharkNinja est une entreprise mondiale de conception de produits et de technologie, dotée d’un portefeuille diversifié de solutions de style de vie cotées 5 étoiles qui améliorent le quotidien des consommateurs partout dans le monde. Grâce à ses deux marques mondiales de confiance, Shark et Ninja , l’entreprise possède un historique éprouvé d’innovation disruptive et de lancement continu de produits grand public qui lui ont permis d’élargir sa présence dans de

About Us SharkNinja is a global product design and technology company, with a diversified portfolio of 5-star rated lifestyle solutions that positively impact people’s lives in homes around the world. Powered by two trusted, global brands, Shark and Ninja , the company has a proven track record of bringing disruptive innovation to market and developing one consumer product after another has allowed SharkNinja to enter multiple product categories, driving significant growth and market share gains. Headquartered in Needham, Massachusetts with more than 4,100 associates, the company’s products are sold at key retailers, online and offline, and through distributors around the world. AI at SharkNinja At SharkNinja, we’re building an AI-native culture. We’re not waiting for the future; we’re creating it. Our people are expected to experiment boldly, adopt new tools, and continuously raise what’s possible to create meaningful impact for our consumers. If you believe the best way to do your job hasn’t been invented yet, you’ll fit right in. *]:pointer-events-auto R6Vx5W_threadScrollVars scroll-mb-[calc(var(--scroll-root-safe-area-inset-bottom,0px)+var(--thread-response-height))] scroll-mt-[calc(var(--header-height)+min(200px,max(70px,20svh)))]" data-turn-id="request-WEB:5af75232-ef91-4092-8d6e-928580f5c1f3-0" data-turn-id-container="request-WEB:5af75232-ef91-4092-8d6e-928580f5c1f3-0" data-testid="conversation-turn-2" data-turn="assistant"> Aperçu du poste L’équipe Global CX définit la façon dont SharkNinja écoute la voix du consommateur, en tire des enseignements et agit en conséquence. Notre mission est de transformer les insights consommateurs en avantage stratégique, afin que chaque interaction renforce notre capacité à offrir des expériences 5 étoiles, tout en ayant un impact positif sur la vie des gens, chaque jour, dans chaque foyer à travers le monde. Nous recherchons un(e) Directeur(trice) principal(e), Strat

About Us InStride Health’s mission is to deliver specialty anxiety and OCD care that works for every kid, teen, young adult, and family who needs it. Through this mission, we are expanding access to insurance-based care, increasing engagement in treatment, and improving treatment outcomes. We are doing this by combining research-backed clinical care and innovative technology to eliminate the major problems with care today: difficulty finding providers, months of waiting to be seen, arduous onboarding processes, and inconsistent use of evidence-based therapies and outcomes tracking. Our vision is to become the nation’s most trusted provider of pediatric anxiety and OCD care. Team InStride Health: Our Core Values Give Heart : We lead with heart, treating patients and their families the way we want our loved ones to be treated. Work Smart : We find smarter ways to solve hard problems and fix the broken mental health system by leveraging technology, diversity of thought, and innovation. Have Humility : We leave our egos at the door, empowering our team to collaborate, celebrate diversity, and adopt a growth mindset. Embrace Community: We all belong. We are in this together, and we never worry alone. We believe in each other and recognize that every voice matters. About the Role We are looking for a virtual Pre-Licensed Therapist to join our team to deliver family-centric and evidence-based care to Children, Adolescents, & Young Adults. This is a fully remote position. Responsibilities: Provide evidence-based individual and group clinical care to patients and families Use measurement-based care to inform treatment planning Lead and collaborate with other care team members (e.g., coach and psychiatrist) Provide feedback on program curricula and training protocols Provide feedback regarding the various applications of technology in treatment Maintain awareness of risk management issues Complete documentation in a timely and thorough manner Participate in in

About Us InStride Health’s mission is to deliver specialty anxiety and OCD care that works for every kid, teen, young adult, and family who needs it. Through this mission, we are expanding access to insurance-based care, increasing engagement in treatment, and improving treatment outcomes. We are doing this by combining research-backed clinical care and innovative technology to eliminate the major problems with care today: difficulty finding providers, months of waiting to be seen, arduous onboarding processes, and inconsistent use of evidence-based therapies and outcomes tracking. Our vision is to become the nation’s most trusted provider of pediatric anxiety and OCD care. Team InStride Health: Our Core Values Give Heart : We lead with heart, treating patients and their families the way we want our loved ones to be treated. Work Smart : We find smarter ways to solve hard problems and fix the broken mental health system by leveraging technology, diversity of thought, and innovation. Have Humility : We leave our egos at the door, empowering our team to collaborate, celebrate diversity, and adopt a growth mindset. Embrace Community: We all belong. We are in this together, and we never worry alone. We believe in each other and recognize that every voice matters. About the Role The Psychiatrist at InStride is responsible for providing high quality psychiatric treatment to our patients. The Psychiatrist is part of a multidisciplinary InStride team and also collaborates closely with families, primary care physicians, and outpatient prescribers to meet patients’ needs. The Psychiatrist creates and maintains a professional, friendly atmosphere for patients, families, InStride staff, and referring physicians, and demonstrates a commitment to InStride Health’s Mission and Core Values. Responsibilities: Provide psychiatric evaluation, medication treatment plan, and ongoing medication management services to children and teens. Collaborate with InStride care team and outpa

About Us InStride Health’s mission is to deliver specialty anxiety and OCD care that works for every kid, teen, young adult, and family who needs it. Through this mission, we are expanding access to insurance-based care, increasing engagement in treatment, and improving treatment outcomes. We are doing this by combining research-backed clinical care and innovative technology to eliminate the major problems with care today: difficulty finding providers, months of waiting to be seen, arduous onboarding processes, and inconsistent use of evidence-based therapies and outcomes tracking. Our vision is to become the nation’s most trusted provider of pediatric anxiety and OCD care. Team InStride Health: Our Core Values Give Heart : We lead with heart, treating patients and their families the way we want our loved ones to be treated. Work Smart : We find smarter ways to solve hard problems and fix the broken mental health system by leveraging technology, diversity of thought, and innovation. Have Humility : We leave our egos at the door, empowering our team to collaborate, celebrate diversity, and adopt a growth mindset. Embrace Community: We all belong. We are in this together, and we never worry alone. We believe in each other and recognize that every voice matters. About the Role We are looking for a virtual Child & Adolescent Therapist to join our team to deliver family-centric and evidence-based care. This is a fully remote position. Responsibilities: Provide evidence-based individual and group treatment to patients and families Use measurement-based care to inform treatment planning Collaborate with other care team members (e.g., coach and psychiatrist) Provide feedback on program curricula and training protocols Provide feedback regarding the various applications of technology in treatment Maintain awareness of risk management issues Complete documentation in a timely and thorough manner Participate in initial and ongoing trainings on the application o

About Us InStride Health’s mission is to deliver specialty anxiety and OCD care that works for every kid, teen, young adult, and family who needs it. Through this mission, we are expanding access to insurance-based care, increasing engagement in treatment, and improving treatment outcomes. We are doing this by combining research-backed clinical care and innovative technology to eliminate the major problems with care today: difficulty finding providers, months of waiting to be seen, arduous onboarding processes, and inconsistent use of evidence-based therapies and outcomes tracking. Our vision is to become the nation’s most trusted provider of pediatric anxiety and OCD care. Team InStride Health: Our Core Values Give Heart : We lead with heart, treating patients and their families the way we want our loved ones to be treated. Work Smart : We find smarter ways to solve hard problems and fix the broken mental health system by leveraging technology, diversity of thought, and innovation. Have Humility : We leave our egos at the door, empowering our team to collaborate, celebrate diversity, and adopt a growth mindset. Embrace Community: We all belong. We are in this together, and we never worry alone. We believe in each other and recognize that every voice matters. About the Role We are looking for a virtual Child & Adolescent Therapist to join our team to deliver family-centric and evidence-based care. This is a fully remote position. Responsibilities: Provide evidence-based individual and group treatment to patients and families Use measurement-based care to inform treatment planning Collaborate with other care team members (e.g., coach and psychiatrist) Provide feedback on program curricula and training protocols Provide feedback regarding the various applications of technology in treatment Maintain awareness of risk management issues Complete documentation in a timely and thorough manner Participate in initial and ongoing trainings on the application o

About Us InStride Health’s mission is to deliver specialty anxiety and OCD care that works for every kid, teen, young adult, and family who needs it. Through this mission, we are expanding access to insurance-based care, increasing engagement in treatment, and improving treatment outcomes. We are doing this by combining research-backed clinical care and innovative technology to eliminate the major problems with care today: difficulty finding providers, months of waiting to be seen, arduous onboarding processes, and inconsistent use of evidence-based therapies and outcomes tracking. Our vision is to become the nation’s most trusted provider of pediatric anxiety and OCD care. Team InStride Health: Our Core Values Give Heart : We lead with heart, treating patients and their families the way we want our loved ones to be treated. Work Smart : We find smarter ways to solve hard problems and fix the broken mental health system by leveraging technology, diversity of thought, and innovation. Have Humility : We leave our egos at the door, empowering our team to collaborate, celebrate diversity, and adopt a growth mindset. Embrace Community: We all belong. We are in this together, and we never worry alone. We believe in each other and recognize that every voice matters. About the Role We are looking for a virtual Child & Adolescent Therapist to join our team to deliver family-centric and evidence-based care. This is a fully remote position. Responsibilities: Provide evidence-based individual and group treatment to patients and families Use measurement-based care to inform treatment planning Collaborate with other care team members (e.g., coach and psychiatrist) Provide feedback on program curricula and training protocols Provide feedback regarding the various applications of technology in treatment Maintain awareness of risk management issues Complete documentation in a timely and thorough manner Participate in initial and ongoing trainings on the application o

What we’re doing isn’t easy, but nothing worth doing ever is. We envision a future powered by robots that work seamlessly with human teams. We build artificial intelligence that enables service robots to collaborate with people and adapt to dynamic human environments. Join our mission-driven, venture-backed team as we build out current and future generations of humanoid robots. Field-based · ~75% travel · Preference for candidates near a major airport About the Role The Client Success Manager owns the health, performance, and growth of a hospital or territory of hospital partners running Moxi robot fleets. You are both the executive relationship owner and the operator behind the numbers: you run leadership check-ins and quarterly business reviews, translate utilization data into a clear story about value delivered, and drive the projects that resolve issues and lift site performance. Priorities shift, sites behave differently, and the playbook is still being written. The CSMs who thrive here make good decisions with incomplete information and move fast without losing rigor. What You'll Be Doing Own executive relationships and the value narrative Serve as the trusted executive contact for each hospital — C-suite sponsors, nursing leadership, and operational stakeholders. Lead recurring leadership check-ins and quarterly business reviews: set the agenda, build the deck, present performance against goals, and close with documented decisions, owners, and next steps. Communicate Moxi's value in each stakeholder's terms — clinical hours returned, delivery volume, staff satisfaction, cost avoidance — continuously, not just at renewal. Use data to drive better outcomes Monitor utilization, adoption, and reliability data across your territory; know each site's baseline, trends, and outliers. Diagnose why a site underperforms, run the intervention, and measure whether it worked. Set and track site-level performance targets with partners, and report on progress h

Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop differentiated products with a focus on novel mechanisms of action that enable meaningful advancements in patient outcomes. Our industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, agitation associated with dementia due to Alzheimer’s disease, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, as well as multiple novel product candidates addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. Together, we are on a mission to solve some of the brain’s biggest problems so patients and their loved ones can flourish. For more information, please visit us at www.axsome.com and follow us on LinkedIn and X . About This Role Axsome Therapeutics is currently searching for a field based Long-Term Care (LTC) Specialty Account Manager (SAM) to drive LTC commercial activities for an assigned geography by executing marketing strategies to ensure a successful launch and make a meaningful difference through the execution of commercial activities. SAMs will be responsible for product performance at a territory level and expected to be a disease state expert, product champion and an account specialist. The SAM will provide account management support and exhibit business knowledge of the local landscape to assess key stakeholders plus future trends within the marketplace. Job Responsibilities and Duties include, but are not limited to, the following: Drive product adoption in LTC facilities Proficient in both virtual and live customer engagements Effectively call on LTC Care teams, building meaningful relationships across the entire LTC ecosystem: Psychiatrists

Job Title : Medical Scientist – Haematology & Blood Transfusion Location : Cork, Ireland Hourly Rate : €35.00 – €50.00 Start Date : ASAP | Duration : Ongoing | Hours : Mon–Fri, 09:00–17:30 We are currently seeking a skilled and experienced Medical Scientist to join a dynamic laboratory team in Cork. This is an excellent opportunity to contribute to a busy diagnostic service where your expertise will be highly valued and supported. Key Responsibilities • Perform a wide range of haematology and blood transfusion tests, including morphology analysis, in accordance with laboratory protocols. • Maintain, calibrate, and troubleshoot laboratory equipment. • Ensure compliance with ISO 15189 and local health and safety standards. • Interpret complex test results and communicate findings effectively. • Collaborate with clinical teams to support diagnosis and treatment planning. Qualifications and Experience • CORU registration (or eligibility to register) • BSc in Biomedical Science (or equivalent recognised qualification) • Proven experience in haematology and blood transfusion, including morphology • Strong analytical and problem-solving skills • Excellent attention to detail and accuracy • Ability to work independently and as part of a multidisciplinary team Why Work with Us? From the moment you register, our focus is on you. Our experienced consultants understand the Irish healthcare landscape and are committed to finding roles that match your skills, preferences, and career goals. We offer: • Weekly payroll with competitive rates • Full compliance and onboarding support • Access to exclusive roles across Ireland • Dedicated consultant support throughout your placement Reasonable Adjustments : If you consider yourself disabled or require any reasonable adjustment during the re