NewDirector, Data Governance & Security Princeton UniversityDirector, Data Governance & SecurityPrinceton, NJReporting to the Associate Vice President for Data Strategy & Innovation, the Director will be responsible for supporting University Advancement’s engagement efforts and overseeing an enterprise-wide role-based approach to data access through data governance, data management, and data security policies and practices. Data Strategy & Innovation is dedicated to housing, managing, analyzing, and disseminating information and data to inform Advancement strategy, foster strong relationships with donors, volunteers, and campus partners, and promote effective integration.
NewDirector Field Procurement Operations Vaco LLCDirector Field Procurement OperationsNew York City, NY$180,000–$220,000Determining 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. Determining compensation for this role (and others) at Vaco/Highspring depends upon a wide array of factors including but not limited to the individual's skill sets, experience and training, licensure and certifications, office location and other geographic considerations, as well as other business and organizational needs.
NewDirector of Nursing JobotDirector of NursingQueens, NY$190,000–$210,000 / yearInformation collected and processed as part of your Jobot candidate profile, and any job applications, resumes, or other information you choose to submit is subject to Jobot's Privacy Policy, as well as the Jobot California Worker Privacy Notice and Jobot Notice Regarding Automated Employment Decision Tools which are available at jobot.com/legal. By applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from Jobot, and/or its agents and contracted partners.
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.
NewSr. Director, Enterprise Procurement Vaco LLCSr. Director, Enterprise ProcurementNew York City, NY$180,000–$260,000Determining 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. Determining compensation for this role (and others) at Vaco/Highspring depends upon a wide array of factors including but not limited to the individual's skill sets, experience and training, licensure and certifications, office location and other geographic considerations, as well as other business and organizational needs.
NewDirector of Client Relations (Nuclear Industry) JobotDirector of Client Relations (Nuclear Industry)New York, NY$170,000–$400,000 / yearInformation collected and processed as part of your Jobot candidate profile, and any job applications, resumes, or other information you choose to submit is subject to Jobot's Privacy Policy, as well as the Jobot California Worker Privacy Notice and Jobot Notice Regarding Automated Employment Decision Tools which are available at jobot.com/legal. You will represent a full portfolio of engineered products and services, working closely with engineering, manufacturing, and project teams to deliver high impact solutions to clients.
NewTax Director Kforce Inc.Tax DirectorParsippany, NJ$175,000–$275,000Employee pay is based on factors like relevant education, qualifications, certifications, experience, skills, seniority, location, performance, union contract and business needs. By clicking “Apply Today” you agree to receive calls, AI-generated calls, text messages or emails from Kforce and its affiliates, and service providers.
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.
NewDirector FP&A - Hospitality Kforce Inc.Director FP&A - HospitalityNew York, NY$160,000–$190,000Employee pay is based on factors like relevant education, qualifications, certifications, experience, skills, seniority, location, performance, union contract and business needs. By clicking “Apply Today” you agree to receive calls, AI-generated calls, text messages or emails from Kforce and its affiliates, and service providers.
NewAssociate Director Access & Reimbursement CSL SeqirusAssociate Director Access & ReimbursementSummit, NJ$210,000–$250,000Convinces internal and external stakeholders about the value of the CSL Seqirus Customer Experience vision; Acts as the voice of the customer with internal stakeholders to build Seqirus’ acumen on customer challenges; Develops and executes business solutions at customers that help enhance CSL Seqirus’ partnership within CSL Seqirus primary channels. With relationship depth and breadth of customer interaction at various (senior management clinical / financial / operational) levels of the customer’s organization, builds and maintains relationships with key individuals to enable market access of CSL Seqirus vaccines, developing a favorable environment for pull-through at the national, regional, and local provider levels.
NewDirector of IT Vaco LLCDirector of ITNew York City, NY$180,000–$200,000Determining 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. Determining compensation for this role (and others) at Vaco/Highspring depends upon a wide array of factors including but not limited to the individual’s skill sets, experience and training, licensure and certifications, office location and other geographic considerations, as well as other business and organizational needs.
NewAssociate Director, Technical Recruiting Vaco LLCAssociate Director, Technical RecruitingBridgewater, NJ$65,000–$80,000Determining 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. Interpersonal Intelligence - Understands self and others’ emotions and is able to manage self and others’ emotions to create a comfortable environment removing internal and external barriers to build rapport with others, including those with diverse opinions and beliefs, by acting with respect, dignity, and integrity.
NewDirector, Women’s Campaign Vaco LLCDirector, Women’s CampaignNew York, NY$130,000–$130,000Determining 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.
NewUS Sales Director- New Business Sales Vaco LLCUS Sales Director- New Business SalesWoodland Park, NJ$125,000–$125,000Determining 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. Determining compensation for this role (and others) at Vaco/Highspring depends upon a wide array of factors including but not limited to the individual’s skill sets, experience and training, licensure and certifications, office location and other geographic considerations, as well as other business and organizational needs.
NewSEC Reporting & Technical Accounting Director Vaco LLCSEC Reporting & Technical Accounting DirectorNew York, NY$220,000–$250,000Determining 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. Public Readiness & SEC ReportingIPO Path: Drive "Public Company Readiness" by preparing initial filings, building scalable disclosure processes, and establishing a robust SOX compliance environment.
NewDirector, Digital Marketing & Communications Vaco LLCDirector, Digital Marketing & CommunicationsNew York City, NY$60–$60Determining 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.
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 of Digital Marketing & Communications Vaco LLCDirector of Digital Marketing & CommunicationsNew York, NY$50–$52Determining 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. My client, a well-known nonprofit organization is seeking a Director of Digital Marketing & Communications to lead and execute digital strategies that increase brand awareness, engagement, and community impact.
NewSenior Director of Accounting Vaco LLCSenior Director of AccountingNew York, NY$175,000–$200,000Determining 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.
Regional Director, LIHTC Property Management Operations Page GroupRegional Director, LIHTC Property Management OperationsNew York, NY$190,000–$235,000 / yearFull timeThe Regional Director, LIHTC Property Management Operations will oversee and optimize property management operations across multiple locations, ensuring compliance with all regulations and delivering exceptional results. A successful Regional Director, LIHTC Property Management Operations should have: Strong expertise in LIHTC property management and compliance requirements.
NewDirector of Accounting Vaco LLCDirector of AccountingMahwah, NJ$140,000–$150,000Determining 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. Own the data definitions of royalties and subrights fields that impact the financial ledger and serve as the point of contact for technology in changes impacting the rights & royalties accounting process.
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, 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.
Fiduciary Director ECLAROFiduciary DirectorNew York, NYResponsibilities:Manage and develop trust centers, associated support, and specialty teams within Information, Management and Technology in roles with focus on delivering moderate complexity and risk. Required Skills:8+ years of Fiduciary Products experience, or equivalent demonstrated through one or a combination of the following: work experience, training, military experience, education.
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.
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.
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.
Veterinarian Medical Director National Veterinary AssociatesVeterinarian Medical DirectorBrooklyn, NY$185,000–$250,000 / 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. Animal Kind Veterinary Hospital is seeking a motivated, collaborative, and experienced Medical Director to lead our thriving, nine-doctor companion animal practice in the heart of Park Slope, Brooklyn.
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.
NewClinical Director 4-2026 Hourchildren.orgClinical Director 4-2026Long Island City, NYPerform additional department or agency-related duties or special projects as directed by the supervisor, the Senior Director of Programs, Chief Impact & Program Officer, or Executive Director. Hour Children (HC) is an organization founded to help incarcerated and formerly incarcerated women and their children successfully rejoin the community, reunify with their families, and build healthy, independent, and secure lives.
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.
NewLicensed Social Worker Assistant Director Care-OneLicensed Social Worker Assistant DirectorBound Brook, NJ$52,000–$72,000 / yearSocial Service functions include but are not limited to: supervising social service staff, direct services, advocacy, counseling, service coordination, education, in-servicing, policy and program development and community relations. Provide for therapeutic intervention to help residents cope with the social and psychological aspects of their illnesses, impairments, or disabilities as well as their feelings about institutionalization and separation from family, community, physical and emotional loss.
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.
NewAssistant Director of Social Services Care-OneAssistant Director of Social ServicesMorristown, NJ$53,000–$70,000 / yearSocial Service functions include but are not limited to: supervising social service staff, direct services, advocacy, counseling, service coordination, education, in-servicing, policy and program development and community relations. Provide for therapeutic intervention to help residents cope with the social and psychological aspects of their illnesses, impairments, or disabilities as well as their feelings about institutionalization and separation from family, community, physical and emotional loss.
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, Medical Writing - Publications JouléAssociate Director, Medical Writing - PublicationsRaritan, NJRemote$160,000–$165,000 / yearProvide expert writing and editing support to ensure timely production of high-quality documents (abstracts, posters, slide presentations, manuscripts, letters to editor, etc.) for publication in medical/scientific journals or presentation at meetings. A PhD, MD, or PharmD with a minimum of 5 years of relevant pharmaceutical/scientific experience is required OR a Master’s (or other advanced degree) with a minimum of 8 years relevant pharmaceutical/scientific experience is required.
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 (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.
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.
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.
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.
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).
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.
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.
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.
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.
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.
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.