Medical Director of Quality – Heart & Vascular RWJBarnabas HealthMedical Director of Quality – Heart & VascularWest Orange, NJWorking in close partnership with the VP for Quality, Heart & Vascular, this leader will leverage data and registry insights to drive performance improvement, oversee clinical event reviews and regulatory compliance, and engage physicians and multidisciplinary teams in fostering a culture of accountability, collaboration, and continuous improvement. RWJBarnabas Health, the largest integrated healthcare system in New Jersey, is seeking a Medical Director of Quality – Heart & Vascular to serve as a key clinical leader driving quality, safety, and performance excellence across our system.
NewDirector, PV QA DSI Daiichi Sankyo, Inc.Director, PV QA DSIBasking Ridge, NJ$184,240–$276,360 / yearFull timeThe role will participate in other PV QA projects, tasks, and initiatives as needed and as instructed, including but not limited to including planning and PV QA executing the Pharmacovigilance Quality Strategy Plan in alignment with the DSI business objectives, review of key REMS documents, Health Authority Commitments, Quality Event management, escalation process and the CAPA oversight across applicable functional areas. Lead the PV inspection management activities by ensuring readiness, compliance, and inspection preparedness for the respective regulatory inspections in alignment with regulatory and company strategy, including coordinating and supporting preparation of CSPV teams and active participation and management of these processes, specifically in the US.
Associate Director, External Supplier QA GMP Daiichi Sankyo, Inc.Associate Director, External Supplier QA GMPBasking Ridge, NJ$153,600–$230,400 / yearFull timeCross-Functional Team Participation: Responsible for working with Quality Leaders in each operating site to influence and affect the necessary operations managed through the leadership teams and will partner closely with other Subject Matters Expert across all the Functional Units (Global ADC Team Members, Pharmaceutical Technology, QA-GMP and QA R&D functional areas, Regulatory Affairs – CMC, Pharmacovigilance, Medical Affairs and Supply Chain) to ensure compliant operations. Quality Management System (QMS): Ensures and support that a robust QMS is in place at CMOs with respect to the facility, equipment & lab instruments, engineering, maintenance, computerized systems and validation activities which complies with GMP guidelines such as ICH and PIC/s as well as FDA regulation requirements, industry best practices and will withstand regulatory inspections by regulatory authorities and regular audits.
Director, Risk Based Quality Management (RBQM) Daiichi Sankyo, Inc.Director, Risk Based Quality Management (RBQM)Basking Ridge, NJ$201,840–$302,760 / yearFull timeOversee RBQM activities for Daiichi Sankyo Portfolio of Studies: Serve as senior level technical RBQM SME and oversee Central Risk Managers to ensure proper implementation and execution of RBQM and inspection readiness. Interacts with and influences internal and external executive level and study level stakeholders on risk based quality management principles, process improvement, metrics design and application and other key drivers of enhanced quality.
Associate Director PV Quality, Americas Daiichi Sankyo, Inc.Associate Director PV Quality, AmericasBasking Ridge, NJ$153,600–$230,400 / yearFull timeProvide operational QA leadership for the respective CSPV teams, including Quality Oversight for the Quality Plan execution, review of key CSPV regulatory documents, Health Authority Commitments, Critical Incidents including, respective escalation process and the CAPA Management Process for the respective CSPV functional areas. Interact with senior CSPV leadership teams to ensure Quality is consistently and proactively represented at program level and along the clinical trial process in support of a proactive quality risk management process.
NewAssistant Director of Nursing (ADON) Bushwick CenterAssistant Director of Nursing (ADON)Brooklyn, NY$120,000–$130,000Bushwick Center for Rehabilitation and Healthcare is a 225-bed rehabilitation and skilled nursing facility located on the border of Brooklyn & Queens. Our staff is committed to ensuring the highest quality of life of all our residents, by maintaining each resident’s dignity and independence.
NewAssistant Director of Nursing (ADON) Skilled Nursing of BronxAssistant Director of Nursing (ADON)The Bronx, NY$130,000–$130,000Skilled Nursing of Bronx is hiring a Assistant Director of Nursing (ADON) in Bronx, NY. DUTIES: Assist the DNS with management responsibilities and in maintaining the quality of care.
NewAssistant Director of Nursing (ADON) Skilled Nursing of BrooklynAssistant Director of Nursing (ADON)Brooklyn, NY$55–$55A Skilled Nursing Facility in Brooklyn, NY is looking to hire an Assistant Director of Nursing (ADON). Assist the Director of Nursing Services (DNS) with management responsibilities and maintaining quality of care.
Clinical Director (LCSW or LMSW) - Behavioral Health Mitchell MartinClinical Director (LCSW or LMSW) - Behavioral HealthStaten Island, NY$100,000–$120,000 / yearA well-established behavioral health organization serving individuals through residential and outpatient programs is seeking a Clinical Director (LCSW or LMSW) to join its leadership team. • The Clinical Director will drive accountability, ensure regulatory excellence, and elevate the quality and consistency of care across the organization.
NewDirector of Estimating Building and Land TechnologyDirector of EstimatingStamford, CTThe ideal candidate will bring deep expertise in ground-up construction estimating, strong leadership capabilities, and a proven track record managing high-value projects from early design through bid execution and project turnover. Building and Land Technology (BLT) is seeking an experienced and strategic Director of Estimating to lead and actively participate in all estimating efforts for complex mid- to high-rise residential and commercial office developments in Stamford, CT.
NewDirector of Finance Vaco LLCDirector of FinanceHoboken, NJ$150,000–$165,000Determining compensation for this role (and others) at Vaco by Highspring depends upon a wide array of factors including but not limited to: the individual’s skill sets, experience and training; licensure and certification requirements; office location and other geographic considerations; other business and organizational needs. With that said, as required by local law, Vaco by Highspring believes that the following salary range referenced above reasonably estimates the base compensation for an individual hired into this position in geographies that require salary range disclosure.
NewBusiness Development Director Vaco LLCBusiness Development DirectorNew York, NY$75,000–$85,000Determining compensation for this role (and others) at Vaco by Highspring depends upon a wide array of factors including but not limited to: the individual’s skill sets, experience and training; licensure and certification requirements; office location and other geographic considerations; other business and organizational needs. Vaco by Highspring values a diverse workplace and strongly encourages women, people of color, LGBTQ+ individuals, people with disabilities, members of ethnic minorities, foreign-born residents, and veterans to apply.
NewDirector / Senior Tax Manager, CPA Kforce Inc.Director / Senior Tax Manager, CPAStamford, CT$165,000–$200,000Summary: In this position, you will lead client relations and business development activities, provide day-to-day accounting support to a portfolio of clients, and manager engagements, prepare tax filings as well as research and planning activities. Employee pay is based on factors like relevant education, qualifications, certifications, experience, skills, seniority, location, performance, union contract and business needs.
NewManager / Director Transaction Services (M&A) Kforce Inc.Manager / Director Transaction Services (M&A)New York, NY$125,000–$200,000Run multiple and challenging Transaction Advisory Services engagements (financial due diligence), participating in transactions related to the acquisitions by private equity investor groups and strategic corporate buyers. Responsibilities Include: Manager/Director Transaction Services will lead buy - side diligence, sell - side diligence, working capital assistance, merger integration and optimization, divestitures and carve outs, and valuation services.
NewAssistant Director of Nursing Care-OneAssistant Director of NursingTeaneck, NJ$114,000–$145,000 / yearAlong with the Director of Nursing, promote positive employee relations, strong customer service ethic and commitment to ongoing staff education and training, May exercise direction over the department in the absence of the Director of Nursing. Assist the Director of Nursing with regulatory compliance and ensure effective communication strategies with all levels of nursing staff to promote effective care delivery.
Director, Regulatory Affairs Advertising and Promotion Daiichi Sankyo, Inc.Director, Regulatory Affairs Advertising and PromotionBasking Ridge, NJ$184,240–$276,360 / yearFull timeThe Director, Regulatory Affairs Advertising and Promotion (RAAP) provides senior strategic and tactical regulatory leadership for U.S. promotional and selected non-promotional communications across assigned products, therapeutic areas, and key business initiatives within the Daiichi Sankyo portfolio, including alliance assets. Interpret evolving FDA regulations, guidances, enforcement trends, compliance letters, and relevant industry developments, including ambiguous or precedent-setting issues, and translate them into actionable regulatory strategy and business guidance.
Associate Director, Regulatory (RIM) Business Systems and Operations Daiichi Sankyo, Inc.Associate Director, Regulatory (RIM) Business Systems and OperationsBasking Ridge, NJ$157,920–$236,880 / yearFull timeThe Associate Director, Business Systems & Operations Management will function at various times as a manager of one or more business systems, as a leader of sub-teams or workstreams within larger projects or programs, as a contributor within various systems-related working groups, and as a senior business analyst, as required. The Associate Director, Business Systems & Operations Management is responsible for managing the operational, administrative, and tactical support of assigned business systems; as well as contributing to projects and initiatives that optimize the use of information technology to achieve departmental, divisional, and enterprise business objectives.
NewDirector of Social Services Care-OneDirector of Social ServicesParamus, NJ$81,000–$100,000 / yearEnsures and documents that residents/families have input into the care planning process; Acts as liaison between residents, families, outside agencies, and the Center Administrator to ensure that the resident's rights are maintained; Takes responsibility for conducting family meetings as needed; functions in a management capacity and adheres to all policies and procedures of the Center as a representative of CareOne Administration; Performs administrative requirements such as completing necessary forms and reports under the direction of the Administrator and submitting such reports to the Administrator and/or consultants as required; Facilitates discharge planning including the development of an organized discharge plan for all customers; Concerns self with the safety of all Center residents in order to minimize the potential for fire and accidents. Also ensures that the Center adheres to legal, safety, health, fire, and sanitation codes by being familiar with his/her in carrying out the Center's fire, safety and disaster plans and by being familiar with current MSDS; Puts customer service first and adheres to the CareOne Culture of Excellence Pledge.
Senior Director, Clinical Safety Scientist Daiichi Sankyo, Inc.Senior Director, Clinical Safety ScientistBasking Ridge, NJ$242,700–$404,500 / yearFull timeLead scientist team to collaborate with safety physicians, regulatory affairs, clinical development, other functions and external partners to deliver high-quality safety assessments, regulatory submissions, aggregate reports, and responses to health authority queries. In addition to operational oversight, this role contributes to the development of global safety processes, talent capability building, and strategic alignment across the broader Clinical Safety and Pharmacovigilance (CSPV) function and the enterprise.
Medical Director National Veterinary AssociatesMedical DirectorNew York, NY$175,000–$200,000 / yearHere’s what to expect when interacting with us: •We’ll always reach out via verified LinkedIn profiles or emails ending in @nva.com•We may also contact you via text message from an identified NVA representative for recruiting-related communication•All job opportunities and applications are hosted on our official careers site: careers.nva.com•There is no cost or confidential information required to apply or be considered for a position If you have any doubts about a communication, feel free to visit our careers page to verify authenticity or email us at hiringhub@nva.com. For positions based in Colorado, NVA provides eligible employees with paid sick and safe leave and public health emergency leave in accordance with the requirements of Colorado's Healthy Families and Workplaces Act.
Senior Director, Clinical Safety MD Daiichi Sankyo, Inc.Senior Director, Clinical Safety MDBasking Ridge, NJ$280,350–$467,250 / yearFull timeThe individual assuming this role may function as a key member of the Global Product Team in collaboration with Clinical Development, Regulatory, Project Management, Biostatistics, Pharmacology, and other departments to strategically manage benefit-risk throughout the lifecycle of the drug. Depending on the status of development of the compound, lead and medical-scientifically direct a team of physicians and scientists responsible for a compound/product including project-specific training and coaching of team members and review of team output cross-functionally.
NewDirector of Admissions ($115K - $135K) Swedish Institute IncDirector of Admissions ($115K - $135K)New York, NY$115,000–$135,000 / yearSwedish Institute – College of Health Sciences is a private college in New York City dedicated to educating students for careers in healthcare fields such as nursing, massage therapy, and allied health programs. The ideal candidate brings a strong balance of data-driven strategy, team leadership, and a passion for helping students take the next step toward impactful careers.
NewSenior Director, GTM Enablement PendoSenior Director, GTM EnablementNew York, NY$220,900–$265,000 / yearYou will scale Command of the Message reinforcement, build AI-native practice and certification loops, strengthen role-based onboarding, and connect enablement activity to measurable outcomes like ramp time, attainment distribution, pipeline quality, and retention. Pendo was founded in 2013 by former product managers, who combined their heads and hearts to build something they wanted but never had as product managers: a simple way to understand and attack what truly drives product success.
NewDirector Medical Monitor JouléDirector Medical MonitorParsippany, NJ$210,000–$335,000 / yearServe as the primary medical contact for investigators and study sites regarding protocol-related medical questions, including subject eligibility and enrollment guidance. System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America.
NewMedical Science Director (Carolinas Region) JouléMedical Science Director (Carolinas Region)Parsippany, NJRemote$200,000–$240,000 / yearEngage with healthcare providers, KOLs, pharmacy stakeholders, and institutional decision-makers to foster trusted relationships within inpatient and outpatient settings. Support medical affairs activities across oncology, infectious disease, nephrology, and acute care through compliant scientific exchange and insight gathering.
Medical Science Director (Mid-Atlantic Region) JouléMedical Science Director (Mid-Atlantic Region)Parsippany, NJRemote$200,000–$240,000 / yearThis role serves as a clinical and scientific resource, facilitating evidence-based discussions, gathering medical insights, supporting clinical research initiatives, and collaborating cross-functionally to help inform medical strategy, education, and patient care. The Medical Science Director is a field-based medical affairs professional responsible for building scientific relationships with healthcare providers, key opinion leaders, and healthcare systems across oncology and related specialty therapeutic areas.
Medical Science Director (Ohio Valley) JouléMedical Science Director (Ohio Valley)Parsippany, NJRemote$200,000–$240,000 / yearEngage with healthcare providers, KOLs, pharmacy stakeholders, and institutional decision-makers to foster trusted relationships within inpatient and outpatient settings. Support medical affairs activities across oncology, infectious disease, nephrology, and acute care through compliant scientific exchange and insight gathering.
NewMedical Science Director Southern CA JouléMedical Science Director Southern CAParsippany, NJRemote$200,000–$235,000 / yearServe as a scientific resource to healthcare providers (HCPs), key opinion leaders (KOLs), pharmacy stakeholders, and institutional decision-makers across inpatient and outpatient healthcare settings. Support medical affairs activities across oncology, infectious disease, nephrology, acute care, and related therapeutic areas through compliant scientific exchange, insight gathering, and cross-functional collaboration.
NewMedical Science Director (New England Region) JouléMedical Science Director (New England Region)Parsippany, NJRemote$200,000–$235,000 / yearA field-based Medical Science Director will support Medical Affairs through compliant scientific exchange, insight gathering, and cross-functional collaboration across oncology and related therapeutic areas (infectious disease, nephrology, acute/critical care). This role partners with HCPs/KOLs, pharmacy leaders, and institutional stakeholders across inpatient/outpatient settings to support medical strategy, evidence generation initiatives, and scientific engagement (congresses, advisory boards, education).
NewMedical Science Director Northern CA JouléMedical Science Director Northern CAParsippany, NJRemote$200,000–$235,000 / yearServe as a scientific resource to healthcare providers, key opinion leaders, pharmacy stakeholders, and institutional decision-makers across inpatient and outpatient healthcare settings. Support medical affairs activities across oncology, infectious disease, nephrology, acute care, and related therapeutic areas through compliant scientific exchange, insight gathering, and collaboration.
Medical Science Director (Mountain Plains) JouléMedical Science Director (Mountain Plains)Parsippany, NJRemote$200,000–$240,000 / yearEngage with healthcare providers, KOLs, pharmacy stakeholders, and institutional decision-makers to foster trusted relationships within inpatient and outpatient settings. Support medical affairs activities across oncology, infectious disease, nephrology, and acute care through compliant scientific exchange and insight gathering.
NewAssociate Director Corporate Communications JouléAssociate Director Corporate CommunicationsParsippany, NJ$135,000–$170,000 / yearJoin a growing biopharmaceutical organization where communications plays a critical role in shaping corporate reputation, supporting key business milestones, and translating complex science into meaningful stories. This is an opportunity to work closely with executive leadership and cross-functional teams to drive both external and internal communications initiatives across a fast-paced, highly visible environment.
Associate Director, Clinical Science Daiichi Sankyo, Inc.Associate Director, Clinical ScienceBasking Ridge, NJ$162,400–$243,600 / yearFull timeUnder supervision of Clinical Science Asset Lead or Clinical Science Lead, drafts development plans, protocol profiles, protocols, informed consent forms, and sections of submission documents. Advanced Technical Expertise: Possess advanced understanding of pre-clinical and clinical research, including protocol writing, data review, study design, and disease area knowledge preferred.
Associate Director, Global Oncology Marketing, Biomarker Strategy Daiichi Sankyo, Inc.Associate Director, Global Oncology Marketing, Biomarker StrategyBasking Ridge, NJ$162,400–$243,600 / yearFull timeCritical responsibilities include contribution to the brand plan, providing commercial input to CDx team, development of tactics such as education to laboratories/pathologists, drive quality initiatives, ensuring adequacy of testing supply in markets and coordinating all activities with regional teams. Apply expertise to challenge strategic and tactical assumptions and refine diagnostic strategies across the product lifecycle, considering competitive pressures, disease prevalence(s), test proficiency / quality assurance, and market access dynamics.
Associate Director, Biostatistics (Late Stage) Daiichi Sankyo, Inc.Associate Director, Biostatistics (Late Stage)Basking Ridge, NJ$175,440–$263,160 / yearFull timeProtocol Development, Case Report Form (CRF; review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex studies including study design, protocol development, CRF review, SAP development, analysis files development, statistical analysis accuracy validation, results interpretation and CSR input and review. May participate in meeting or teleconferences with Health Authorities Global BDO Strategy to Improve Drug Development: Primarily participates and may occasionally lead moderately complex initiatives, with some level of supervision, to improve the harmonization and efficiency of drug development which leads to cost savings and shortened timelines for the company.
Medical Director in Freehold, NJ TeamHealthMedical Director in Freehold, NJFreehold, NJPart timeOur comprehensive clinical and operational leadership team will support your transition into our medical practice with a comprehensive 3-month onboarding program along with a dedicated clinical field mentor and support from industry leading clinical experts in post-acute medicine. The medical practice is part of TeamACO, a dedicated long-term Accountable Care Organization participating in the Medicare Shared Savings Program for our clinicians, which could result in you receiving a portion of the shared savings if certain criteria are met.
OB/Gyn Hospitalist Medical Director in Westwood, NJ TeamHealthOB/Gyn Hospitalist Medical Director in Westwood, NJWestwood, NJFull timeIdeal for experienced OB/Gyn hospitalists or physicians transitioning from private practice who are seeking a collaborative environment and the opportunity to lead and grow a high-quality program. Known as The Hub of the Pascack Valley, this vibrant suburban community features a walkable downtown, boutique shopping, local restaurants, parks, and top-rated schools.
NewAssociate Director, Medical Review Lead, MSRM - Remote Agios PharmaceuticalsAssociate Director, Medical Review Lead, MSRM - RemoteNew York, NYRemote$185,369–$308,948 / yearThe current base salary range for this position is expected to be between $185,369 and $308,948 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators. This role provides oversight of medical review for Individual Case Safety Reports (ICSRs) across investigational and marketed products, ensuring medical accuracy, regulatory compliance, and high-quality safety data to support pharmacovigilance and risk management activities.
NewManaging Director Commercial Underwriting Webster BankManaging Director Commercial UnderwritingNew York, NY$200,000–$210,000 / yearLead deal management process and all diligence activities, prepare financial models, prepare deal screen and final credit approval presentations in accordance with Websters credit policies and procedures; present and lead credit committee discussion; manage all facets of loan closing with product partners (Treasury, Portfolio, Operations, Loan Syndication). Managing Director, Commercial Underwriting supports the Healthcare CRE team in originating, underwriting, and arranging commercial loans, in addition to credit requests and risk management activities related to credit origination, refinancings and loan modifications for existing portfolio relationships.
NewAssociate Director, Safety Systems Lead, Medical Safety & Risk Management - Remote Agios PharmaceuticalsAssociate Director, Safety Systems Lead, Medical Safety & Risk Management - RemoteNew York, NYRemote$153,541–$230,312 / yearThe Associate Director, Safety Systems Lead will be responsible for all technical aspects of the safety database environment, supporting business requirements for case processing and submission compliance, facilitating and managing interfaces with other systems, providing data to all relevant parties, serving as the safety systems technical subject matter expert and overseeing relevant safety systems vendors. Ensure safety systems remain continuously compliant, validated, and inspection-ready by overseeing computer system validation (CSV) deliverables (e.g., Validation Plans, Summary Reports, UAT), partnering with QA on audit trails/evidence, and maintaining adherence to SOPs, GxP, ICH, FDA regulations, EU Annex 11, and 21 CFR Part 11.
NewDirector of Business Development, Legal, Compliance, and Risk (Healthcare) bdo consultingDirector of Business Development, Legal, Compliance, and Risk (Healthcare)New York, NY$150,000–$200,000 / yearUnder the direction of the National Director, Channel Business Development and in collaboration with practice leadership, and the Chief Business Development Officer, the Director of Business Development, Legal, Compliance & Risk, is responsible for driving, monitoring, and improving sales performance for BDO’s legal channel service offerings including electronic discovery, digital forensics, information governance, cyber security, data analytics, forensic accounting, and investigations. Bachelor’s Degree and five (5) or more years of business development / marketing experience in a professional services environment or industry relevant firm required; OR High School Diploma/GED and seven (7) or more years of business development / marketing experience in a professional services environment or industry relevant firm, required.
NewMedical Director, Sickle Cell Disease, Clinical Development Agios PharmaceuticalsMedical Director, Sickle Cell Disease, Clinical DevelopmentNew York, NY$221,600–$369,333 / yearThe current base salary range for this position is expected to be between $221,600 and $369,333 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators. Follow important developments and relevant trends in scientific literature and develop/maintain contracts with external experts to support understanding of the candidate drug effects and to gain strategic insights to the further development and placement of study and overall program.
NewDirector, Commercial Risk Evaluation and Mitigation Strategies (REMS) Lead - Remote Agios PharmaceuticalsDirector, Commercial Risk Evaluation and Mitigation Strategies (REMS) Lead - RemoteNew York, NYRemote$183,549–$230,312 / yearThe Director leads the development, implementation, and ongoing management of commercial related REMS activities to support compliance, patient safety, and effective execution across sales, field marketing, patient support, specialty distribution and other customer-facing teams. The current base salary range for this position is expected to be between $183,549 and $230,312 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators.
NewAssociate Director, Forecasting & Performance Analytics, Commercial Operations & Analytics - Remote Agios PharmaceuticalsAssociate Director, Forecasting & Performance Analytics, Commercial Operations & Analytics - RemoteNew York, NYRemote$153,541–$230,312 / yearThe current base salary range for this position is expected to be between $153,541 and $230,312 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators. Build, maintain, and evolve operational, unit-based forecasts across the portfolio – demand, revenue, and patient-based models – including scenario planning and risk and opportunity assessments for multiple launches and in-line products.
NewEngineering Director - Tax Product Development bdo consultingEngineering Director - Tax Product DevelopmentNew York, NY$210,000–$325,000 / yearExtensive knowledge of cloud platforms (Azure, AWS GCP), AI platforms like OpenAI, Anthropic, DevOps practices, CI/CD pipelines, containerization (Docker, Kubernetes), and database technologies (SQL, NoSQL), preferred. The Engineering Director, Product Technical Lead is responsible for product engineering for cloud-based solutions for a Tax service line, including Partnership, Corporate, Indirect, and Strategic Tax Services within BDO.
Director, Early Phase Biostatistics Daiichi Sankyo, Inc.Director, Early Phase BiostatisticsBasking Ridge, NJ$201,840–$302,760 / yearFull timeMentoring and Coaching Junior Statisticians: Mentoring the study level statisticians for the assigned projects to ensure optimal statistical handling and quality deliverables including Protocol Development, Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and Clinical Study Report (CSR). Drug Development Strategy: Provides input to the clinical development plan to ensure the overall strategy can deliver the pre-specified product profile, is logical, scientifically sound, proposed studies have appropriate designs, efficacy and safety information to be collected meet regulatory agencies’ requirements for countries and regions the drug is to be submitted.
NewAccount Director Enterprise Sales - Northeast PendoAccount Director Enterprise Sales - NortheastNew York, NYRemote$280,000–$320,000 / yearEnterprise deal leadership: Act as the internal lead for complex enterprise opportunities, coordinating cross-functional partners across Solutions Engineering, Customer Success, Legal, Product, and executive leadership. Pendo was founded in 2013 by former product managers, who combined their heads and hearts to build something they wanted but never had as product managers: a simple way to understand and attack what truly drives product success.
NewExecutive Director, Oncology R&D, Global Clinical Lead Daiichi Sankyo, Inc.Executive Director, Oncology R&D, Global Clinical LeadBasking Ridge, NJ$329,025–$548,375 / yearFull timeClinical Monitoring Planning: Oversees and coordinates Sponsor oversight of CRO clinical Monitoring activities, including plan for internal communication and issue escalation with Clinical Study Lead (CSL) Clinical Surveillance: Documents ongoing Clinical Monitoring review of data for safety (with Clinical Safety Pharmacovigiliance) and quality at project level; Ensures global consistency of clinical Monitoring activities; Defines or contributes to department level surveillance activities across projects Study strategy: Interacts with leaders of each function to develop study strategy; Approves project or TA-level TM and biomarker strategy in collaboration with Translational Medicine and Clinical Pharmacology; Attends regulatory agency meetings and leads clinical strategy discussions Study planning and execution: Develops prospective contingency plans for management of key risks across a large project or a portfolio of projects or across the Therapeutic Area; Clearly defines priorities and high level execution plans across projects within and outside of Daiichi Sankyo; Supports effective communication and decision-making process cross-functionally and cross-regionally at department level Study Outputs: For large-studies/programs, consults on responses to IRBs and HA; Has strong understanding of statistics and study design principles applicable to primary and efficacy and safety endpoints in registrational trials to critically assess study conclusions External collaboration: Ensure continuous, effective alignment within / between CRO and vendors; For large, multiple indication project in late development, develops and leads Ad-Board with top tier KEEs for project level strategic advice; Develops and leads steering committee for Phase 3 registrational study; Consults with KEEs for advice on complex development or safety issues; Maintains and leads external collaborations and advisory panels at department level People Management: Assign staff with appropriate training and experience or arrange requisite support to lead large study teams, coordinate complex studies, lead projects, and/or ensure proper medical oversight; Monitor and manage direct report’s performance in such roles, ensuring that there is proper understanding of task complexity and management of key risks; Participate in department’s planning for staff and cross-functional staffing plans for the Therapeutic Area. Provides senior level clinical representation at meetings with health authorities; Leads the creation of developmental and regulatory strategy; Accountable for performance of CROs; Routine interactions with senior management of CRO/ARO, as needed; Accountable for clinical development plans, protocol profiles and sections of key submission documents; Represents Clinical Development as team leader or as supervisor of team leaders; Accountable for Clinical Development input into commercial strategy including Translational Medicine and biomarker strategy; Thought partner in driving Business Development decisions in collaboration with External Scientific Affairs dept.