research director

4SiGHT Research & Analytics

<div></div><div><div><div><div><div><div><h2 class="jobSectionHeader"><b>At 4SiGHT, our approach of being an employer brand is centered around...</b></h2>
</div></div></div></div><div></div><div><div><div><div><h5 class="jobSectionHeader"><b>SAY</b></h5>
<div><div><p>Our team speaks positively about 4SiGHT among colleagues, clients and their friends</p>
</div></div></div></div></div><div></div><div><div><div><h5 class="jobSectionHeader"><b>STAY</b></h5>
<div><div><p>Associate their future with 4SiGHT</p>
</div></div></div></div></div><div></div><div><div><div><h5 class="jobSectionHeader"><b>STRIVE</b></h5>
<div><div><p>Feel motivated to exert extra effort for 4SiGHT</p>
</div></div></div></div></div></div><div></div><div><div><div><div><h4 class="jobSectionHeader"><b>PASSIONATE ABOUT MARKET
</b><br>
<b>RESEARCH &amp; ANALYTICS</b></h4>
<div><div><p>4SiGHT is an exciting place to work; we&rsquo;re growing quickly and we&rsquo;re constantly on the lookout for talented people who can help take our business to new heights and work with some of the leading brands and organisations across the region.</p>
</div></div></div></div></div><div></div><div><div><div><h4 class="jobSectionHeader"><b>WHO DO WE HIRE?</b></h4>
<div><div><p>Whether you&rsquo;ve been in the research industry for a long time or recently graduated, you&rsquo;ve come to the right place. We&rsquo;re always interested in hearing from talented individuals who might be our next great research manager, intern or director.</p>
</div></div></div></div></div><div></div><div><div><div><h4 class="jobSectionHeader"><b>WHAT CAN I EXPECT IF I JOIN
</b><br>
<b>THE TEAM?</b></h4>
<div><div><p>A challenging, supportive, fast-paced and exciting working environment where you will be constantly challenged to push yourself to new heights, whilst working on a wide variety of projects for a diverse selection of clients.</p>
</div></div></div></div></div></div><div></div><div><div><div><div><p>WE ARE HIRING</p></div></div></div></div></div></div><p></p>
<br><div><h3 class="jobSectionHeader"><b>Director - Insights, Quantitative Research, Jeddah</b></h3>
<p>Jeddah, Saudi Arabia</p>
<div><div><p><b>Position:</b> Director &ndash; Insights</p>
<p><b>Core Practice:</b> Quantitative Research</p>
<p><b>Domain</b>: Cross category, with expertise in BFSI</p>
<p><b>Location</b>: Jeddah, Saudi Arabia</p>
<p>To effectively manage growth of business financially (top and bottom line) through the development of people/staff, the development of client relationships and self.</p>
<p><b>Job Content</b></p>
<ul><li>Lead the business and projects hands-on</li>
<li>Meeting corporate business objectives</li>
<li>Profitability of the business unit</li>
<li>Formulation and implementation of competitive business strategies for the unit</li>
<li>Promotion of 4SiGHT brand in the region</li>
<li>Be part of the product development</li>
<li>Providing leadership support to business unit</li>
<li>Organization culture and value system</li>
</ul><p><b>Accountability/Responsibility</b></p>
<ul><li>Setting of annual budget/plan and its execution.</li>
<li>Strategic planning/visioning/forecasting</li>
<li>Translates strategic goals and objectives into specific programs.</li>
<li>Influences policies and climate for the organization and links with mission of whole process.</li>
<li>Responsible for standing of the brand in the industry.</li>
</ul><p><b>Know-How (Knowledge/Experience)</b></p>
<p>Quantitative Craft Skills, at least 10+ years of experience, Having led teams in the current / earlier roles, Sales and negotiation ability. Well oriented on newer data science streams and analytics.</p>
<p><b>Abilities, Skills and Personal Attributes</b></p>
<ul><li>Has the ability of a good leader and practices situational leadership.</li>
<li>Should be a good motivator</li>
<li>Good communication skills &ndash; communicates in an outgoing manner, has good listening and presenting abilities</li>
<li>Is a good role model</li>
<li>Has a good awareness of self</li>
<li>Is a self starter, passionate and has entrepreneurial spirit</li>
<li>Has a good awareness of the competitive environment</li></ul></div></div></div>
<br><i>Please note that due to the large number of applications that we receive, we are unable to provide individual feedback to unsuccessful applicants.</i>

Research: Director - Insights, Jeddah

Sanofi

<div><p><b>Job title: </b>Clinical Research Director - Rare Diseases</p><p><b>
Location: </b>Cambridge, MA / Morristown, NJ</p><p></p><p><b>
About the Job</b></p><p>
Join the engine of Sanofi&rsquo;s mission &mdash; where deep immunoscience meets bold, AI-powered research. In R&amp;D, you&rsquo;ll drive breakthroughs that could turn the impossible into possible for millions.</p><p></p><p>
The Clinical Research Director (CRD), Rare Diseases Therapeutic Area, is responsible for creation and execution of the clinical development strategy for assigned projects/studies in this Therapeutic Area (TA). The CRD is responsible for the creation of the clinical development plan in alignment with the project strategy, its endorsement by governance and its execution in close collaboration with clinical operations. The CRD is expected to advance scientific and clinical knowledge and lead clinical study development in alignment with the asset scientific and business strategy. The role will support developing innovative therapies, particularly with an initial focus in the pulmonary space. The CRD is expected to contribute to the growth of the Rare Blood Disorders TA by both being a driver of clinical and scientific knowledge and advancing operational capabilities.</p><p></p><p><b>
About Sanofi</b><br>
We&rsquo;re an R&amp;D-driven, AI-powered biopharma company committed to improving people&rsquo;s lives and delivering compelling growth. Our deep understanding of the immune system &ndash; and innovative pipeline &ndash; enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people&rsquo;s lives.</p><p><b><br>
Main Responsibilities:</b></p><ul><li><p>
Create clinical development strategy and plans for one or more assets</p></li><li><p>
Lead and coordinate cross-functional teams to design, implement, and execute clinical development plans and studies</p></li><li><p>
Align clinical development strategy with the global project team and internal partners, such as clinical operations, translational medicine, regulatory affairs, biostatistics, drug discovery, drug safety, marketing</p></li><li><p>
Advance the clinical development plan through internal management review</p></li><li><p>
Lead a clinical sub team to design clinical studies and to create study protocols</p></li><li><p>
Execute the clinical development plan in close collaboration with clinical operations</p></li><li><p>
Advance scientific and clinical knowledge in rare diseases</p></li><li><p>
Incorporate new trial, scientific and digital methodologies</p></li><li><p>
Pro-actively progress study execution</p></li><li><p>
Oversee the execution of clinical studies in compliance with internal SOPs, GCP, ICH guidelines and other regulations</p></li><li><p>
Review documents supporting clinical development such as Investigator&rsquo;s brochure, regulatory documents for IND / CTA, clinical sections of integrated development plans, and submission dossiers for regulatory approval</p></li><li><p>
Engage with health authorities (contribute to health authority submissions (such as new drug application) and timely response to regulatory reviews)</p></li><li><p>
Serve as a medical expert and provide strategic input to early-stage programs
</p></li><li><p>Collaborate with external experts, key opinion leaders, and investigators to advance clinical research</p></li><li><p>
Represent Sanofi at scientific conferences and regulatory meetings</p></li></ul><p><b>
Scientific and Technical Expertise:</b></p><ul><li><p>
Has and maintains deep scientific, technical and clinical expertise in the therapeutic area</p></li><li><p>
Understands and keeps updated with the pre-clinical, clinical pharmacology and data relevant to the molecule of interest</p></li><li><p>
Critically reads and evaluates relevant medical literature with deep understanding of the data and status from competitive products</p></li><li><p>
Maintains visibility within the Therapy therapeutic area to maintain credibility with internal and external stakeholders</p></li></ul><p><b>
On Clinical Development, the CRD:</b></p><ul><li><p>
Designs the global clinical development strategy (in close cooperation with other members of the team, particularly Regulatory Affairs end Health Economics) and leads the clinical development with regard to ongoing development activities and planned LCM for labelling changes</p></li><li><p>
Assessment of the Clinical benefit &ndash;risk profile during development and LCM on an ongoing basis, in strong collaboration with GPE and the CSO team</p></li><li><p>
Provides clinical input to the Target Product Profile</p></li><li><p>
Adjusts and updates the clinical strategy when necessary according to the project progression and information available</p></li><li><p>
Contributes to the life cycle management strategy for the project whenever appropriate</p></li></ul><p><b>
The CRD is representative for Clinical Development:</b></p><ul><li><p>
at the Project Team</p></li><li><p>
in meetings with Regulatory Agencies</p></li><li><p>
in Steering Committees (SC) and Data Monitoring Committees (DMC)</p></li><li><p>
at the Benefit Risk Assessment Committee</p></li><li><p>
at the Submission Task Force. Provides clinical input and reviews the product information (Summary of Product Characteristics or equivalent)</p></li></ul><p><b>
The CRD generates documents:</b></p><ul><li><p>
Generates the Clinical Development Plan</p></li><li><p>
Prepares the clinical part of meeting requests and briefing packages for meetings with Regulatory agencies</p></li><li><p>
Generates the extended synopsis for clinical trials and reviews the protocols and protocol amendments prepared by the Clinical Study Director (CSD)</p></li><li><p>
Writes or updates the clinical section of the Clinical Investigator Brochure and the clinical parts of the Clinical Trial Authorization dossier (IMPD, IND) in collaboration with the pharmacovigilance (GPE) department and the clinical pharmacologist</p></li><li><p>
Reviews and when appropriate approves the committees charters</p></li><li><p>
Prepares with the support of the medical writing department the summary of clinical efficacy and clinical overview of the Common Technical Document (CTD). Provide input and reviews all clinical sections of the CTD (clinical pharmacology, summary of clinical safety&hellip;) and other sections whenever appropriate</p></li><li><p>
Prepares answers to questions from Regulatory Agencies on the clinical efficacy of the project and collaborates with GPE in preparing answers on the clinical safety of the project, collaborates on other sections whenever appropriate</p></li><li><p>
In charge of the medical/clinical assessment of license-in opportunities</p></li></ul><p></p><p><b>
About You</b></p><p><b>
Experience / Skills:</b></p><ul><li><p>
MD or MD/PhD in a relevant scientific discipline, preferably pulmonology, with at least 2 years relevant experience in clinical development within the pharmaceutical industry, academia, or government agencies such as the NIH, FDA, or other equivalent national or international public health and regulatory organization</p></li><li><p>
Experience/enthusiasm in advancing assets from discovery into clinical development (experience in pharma or academia)</p></li><li><p>
Have experience in novel approaches to translational medicine</p></li><li><p>
Demonstrate problem solving skills</p></li><li><p>
Understand and keep updated with the pre-clinical, clinical pharmacology and clinical data relevant to the molecule of interest and the respective therapeutic area</p></li><li><p>
Strong leadership skills with the ability to influence and collaborate effectively in a matrix environment</p></li><li><p>
Excellent communication and presentation skills, with the ability to articulate complex scientific concepts to diverse audiences</p></li><li><p>
Proven track record of scientific publications and presentations at international conferences</p></li></ul><p></p><p><b>
Why Choose Us?</b></p><ul><li><p>
Bring the miracles of science to life alongside a supportive, future-focused team.</p></li><li><p>
Discover endless opportunities to grow your talent and drive your career, whether it&rsquo;s through a promotion or lateral move, at home or internationally.</p></li><li><p>
Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.</p></li><li><p>
Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks&rsquo; gender-neutral parental leave.</p></li></ul><p></p><p>
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.</p><p>
#GD-SA
<br>
#LI-SA</p><p>
#LI-Onsite</p><p>
#vhd</p><p>
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.</p></div>

Clinical Research Director - Rare Diseases

<div><p><b>Job title</b><b>:</b><b> </b>Clinical Research Director (CRD)</p><p><b>
Location: </b>Cambridge, MA / Morristown, NJ</p><p></p><p><b><br>
About the job</b></p><p>
Join the engine of Sanofi&rsquo;s mission &mdash; where deep immunoscience meets bold, AI-powered research. In R&amp;D, you&rsquo;ll drive breakthroughs that could turn the impossible into possible for millions.</p><p></p><p><b>
Our Team:</b></p><p>
To support sustainable growth Sanofi Global Development ambition is to be the industry-leading Development organization, using impactful therapeutic innovation that turns hope into reality for people.Therapeutic Areas lead the development of therapies by overseeing the portfolio of development projects and execution of the development programs through the multi-disciplinary Global Project Team (GPT).</p><p></p><p><br>
The <b>Clinical Research Directo</b><b>r</b><b> (CRD) </b>is the <b>medical expert in the Development of R&amp;D programs</b>. The role requires a well-organized, strategically and, operationally focused, resourceful individual with very good emotional intelligence, self-motivation, solid analytical skills, and the ability deliver to multiple tasks.</p><p></p><p><b><br>
Our Project:</b></p><p>
Lunsekimig is a novel bi-specific nanobody targeting both TSLP and IL-13. Lunsekimig is in development across multiple immunology disease areas. We are seeking a highly motivated clinician-scientist to lead clinical trials in the respiratory space.</p><p></p><p><b>
About Sanofi</b></p><p>
We&rsquo;re an R&amp;D-driven, AI-powered biopharma company committed to improving people&rsquo;s lives and delivering compelling growth. Our deep understanding of the immune system &ndash; and innovative pipeline &ndash; enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people&rsquo;s lives.</p><p></p><p><b>
Main responsibilities:</b></p><p>
The role of the CRD is to:</p><ul><li><p>
Provide medical expertise in the Study team to conduct the clinical studies from early phases to LCM programs</p></li><li><p>
Collaborate with other medical and clinical scientific experts DMDs or DSDs in the project under the leadership of the Global Project Head, with the Global safety Officer, Regulatory Strategist and other key functional representatives to deliver development strategy and prepare/assist with regulatory bodies interaction</p></li><li><p>
Develop the study level regulatory documentation (Abbreviated Protocol, Protocol, Amended protocol) for their project, lead other development activities pertaining to study start-up (e.g. pressure test, competitive intelligence, patient engagement, cluster feasibility, study risk assessment etc&hellip;)</p></li><li><p>
Provide appropriate medical input &amp; support for all activities related to clinical studies conduct such as answers to IRBs and HA questions, protocol scientific and medical training, medical review of data within the scope of the Centralized monitoring, clinical and medical information for the study team, medical advisors/Clinical Project Leaders from Clinical Study Units, and investigators</p></li><li><p>
Contribute to the clinical part of Common Technical Document for submission to regulatory bodies (FDA, EMA, PMDA etc&hellip;) and answer to questions from health authorities.</p></li><li><p>
Be the medical reference in the Clinical Study team, ensuring the medical relevance of the clinical data</p></li></ul><p></p><p><b>
Key responsibilities include:</b></p><p><b>
Leading the clinical development plan strategies</b></p><ul><li><p>
Responsible for the clinical development plans and clinical sections of integrated development plans (IDP)</p></li><li><p>
Collaborate with other CRDs/DSDs within the project, ensures leadership, builds consensus, coordinates action plans with stakeholders to resolve project-related issues, anticipates potential issues (sharing lessons learned) across the project or study teams</p></li><li><p>
Raise study or project-level issues to the project head and propose related corrective action plans</p></li><li><p>
Contribute in the definition of the product value proposition (TVP), Target Product Profile (TPP) and market access strategy (in collaboration with respective functions) and the focus of the research strategy, by providing input on existing clinical needs and approaches to clinical development strategies for research projects</p></li><li><p>
Collaborates with external partners, regulators, scientific experts and internal stakeholders
</p></li><li><p>Provide operational expertise to project clinical sub team, as needed</p></li><li><p>
Evaluates relevant medical literature and status from competitive products</p></li></ul><p><b>
Lead, Support and oversee the execution of clinical development and studies
</b></p><ul><li><p>Collaborate and communicate appropriately with all function stakeholders (e.g. clinical operations, project management, Patient Safety and Pharmacovigilance, regulatory, Finance, Scientific External Engagement, Procurement etc&hellip;), responsible for timelines, budgets and contingency/risk management plans to assure successful execution of the clinical trials in compliance with Good Clinical Practice (GCP), applicable laws and regulations as well as applicable standard operating procedures (SOPs)
</p></li><li><p>Develop the abbreviated protocol, the final protocol and protocol amendments
</p></li><li><p>Develop/review the Core Study Informed Consent Form (CSICF)</p></li><li><p>
Develop/review Study committee Charters</p></li><li><p>
Collaborate on key medical and clinical questions with the Global feasibility manager to prepare and interpret feasibility and competitive intelligence results
</p></li><li><p>Review and provide clinical input across different study documents Vendors RFPs, e-CRF, eCOA etc</p></li><li><p>
Provide medical/clinical input to study-related documents such as study plans e.g. Study risk management plan, Monitoring and centralized monitoring plans
</p></li><li><p>Participate in the elaboration of training material and presentations at the investigator meetings/local teams trainings</p></li><li><p>
Answer to medical questions raised by HA, EC/IRBs, sites</p></li><li><p>
Ensure quality of clinical data through continuous data validation, blinded Data review on summary tables or electronic data visualization during clinical trial conduct (AE dedicated review, and Clinical Case review for safety data and statistical surveillance for efficacy data,&hellip;)
</p></li><li><p>Ensure trial master file documents readiness and availability, and mandatory trainings linked to the clinical function</p></li><li><p>
Lead the study specific committees (IDMC, steering com, adjudication &hellip;) with operational support
</p></li><li><p>Co-Develop the SAP in collaboration with biostatistical team</p></li><li><p>
Responsible for key results preparation</p></li><li><p>
Develop/Review the clinical study report
</p></li></ul><p><b>Responsibilities related to regulatory and safety documents and meetings</b></p><ul><li><p>
Review and/or contribute in the clinical section of the Investigator&rsquo;s brochure, CTA, IND, DSUR, DRMP, RMP</p></li><li><p>
Write/review the clinical sections of the BLA/CTD, Briefing packages for regulatory meetings, PSP/PIP</p></li><li><p>
Ensures clinical data meets all necessary regulatory standards</p></li><li><p>
Collaborates with the Patient Safety GSO to detect and document any safety signal</p></li><li><p>
Participates in Advisory Committee preparation</p></li></ul><p><b>
Scientific Data evaluation and authorship</b></p><ul><li><p>
Participate and author manuscripts and abstracts
</p></li><li><p>Establish and maintains appropriate collaborations with knowledge experts or advisory boards</p></li><li><p>
Contribute on an ad hoc basis to specific tasks such as the evaluation of potential in-licensing candidates for the therapeutic area and serves as the clinical advisor to research teams</p></li></ul><p></p><p><b><br>
About you</b></p><p><b>
Experience</b><b>:</b></p><ul><li><p>
At least 3 years previous experience in clinical development in pharmaceutical industry or a CRO or medical experience in clinical development in an Healthcare institution. Background in respiratory, allergy, or immunology preferred.</p></li></ul><p><b>
Soft skills</b><b>:</b></p><ul><li><p>
Very good communication skills (verbal and written) for interactions across functional areas and for interactions with key regulatory agencies</p></li><li><p>
Excellent problem solving capability</p></li><li><p>
Demonstrated capability to challenge decision and status quo with a risk-management approach</p></li><li><p>
Ability to negotiate to ensure operational resources are available for continued clinical conduct</p></li><li><p>
Very good teaching skills, demonstrated ability to assist and train others</p></li><li><p>
Ability to work within a matrix model</p></li><li><p>
International/ intercultural working skills</p></li><li><p>
Open-minded to apply new digital solutions</p></li></ul><p><b>
Technical skills</b><b>:</b></p><ul><li><p>
Understanding of pharmaceutical product development and life cycle management</p></li><li><p>
Very good Scientific and medical/clinical expertise</p></li><li><p>
Very good expertise in clinical development and methodology of clinical studies</p></li></ul><p><b>
Education:</b></p><ul><li><p>
MD (Doctor of Medicine) or equivalent patient care-related medical degree (DO, international equivalents, etc.) required</p></li></ul><p><b>
Languages</b>:</p><ul><li><p>
English fluent (spoken and written)</p></li></ul><p></p><p><b>
Why Choose Us?</b></p><ul><li><p>
Bring the miracles of science to life alongside a supportive, future-focused team.</p></li><li><p>
Discover endless opportunities to grow your talent and drive your career, whether it&rsquo;s through a promotion or lateral move, at home or internationally.</p></li><li><p>
Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.</p></li><li><p>
Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks&rsquo; gender-neutral parental leave.</p></li></ul><p></p><p>
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.</p><p>
#GD-SA
<br>
#LI-SA</p><p>
#LI-Onsite</p><p>
#vhd</p><p>
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.</p></div>

Clinical Research Director, I&I

ObjectiveHealth

<div>Description:
<p><b>
Clinical Research Site Director</b></p><p>
ObjectiveHealth is currently seeking a qualified candidate for the full-time position of Clinical Research Site Director. The ideal candidate will have prior experience in site leadership and 5 years of experience coordinating industry-sponsored clinical trials.</p><p><b>
Who We Are</b></p><p>
ObjectiveHealth is a clinical research company that uses proprietary technology to:</p><ul><li>
Increase patient access to research trials within our communities,</li><li>
Provide physicians with enhanced care options for current patients, and</li><li>
Deliver superior clinical research enrollment metrics to Pharma sponsors.</li></ul><p>
All with the goal of <i>Improving Patient Outcomes </i>at the point of care.</p><p>
We want you to join us in doing just that.</p><p><b>
Who You Are</b></p><ul><li>
A lover of patient interaction and skilled at providing patient care</li><li>
A team player with a bias for action and an attitude that takes personal responsibility</li><li>
A proven leader among your peers and teams</li><li>
Skilled in all aspects required for conducting an IRB approved clinical trial protocol: identification, screening, randomization, and enrollment of patients, conducting clinic visits, etc.</li><li>
Skilled at performing and assisting with direct patient care activities: consenting patients, physical assessments, blood draws, medication administration, ECG, etc.</li><li>
Possess an acute attention to detail for clean data entry, regulatory compliance, productive site visits, efficient study set-up and maintenance, and strict protocol adherence</li><li>
An expert communicator with the goal of fostering relationships between the research team, PIs, Sponsors, Monitors, and others</li><li>
A strong advocate for Company values, mission, and initiatives</li><li>
Not easily distracted: You have the ability to stay focused while running different protocols, resolving and submitting IRB responses and audit findings, tracking AE and SAE events, and maintaining eSource material for assigned studies</li><li>
Energized by the idea of playing a role in the future of new therapy development in the areas of Gastroenterology, Urology, Respiratory, Orthopedics, Dermatology, and/or Oncology</li></ul><p><b>
What Success Looks Like for This Role</b></p><ul><li>
Taking ownership of assigned studies and patients</li><li>
Communicating promptly and effectively with leadership and coworkers when you have a question or see something that needs correction</li><li>
Showing up on time, every time</li><li>
Ensuring strict compliance to the laws, regulations, and requirements of all applicable governing bodies</li><li>
Learning and using the technologies we provide to enhance your day-to-day activities</li><li>
Embodying our core values of Compassion, Integrity, Collaboration, Innovation, Velocity, and Dedication</li></ul><p><b>
What We Offer</b></p><p>
Competitive compensation, 401(k) with Company match, a clear career pathway for advancement within the Company, Short- and Long-Term Disability, Health Savings and Flexible Spending Accounts, Health, Dental and Vision insurance Plans, Generous PTO, Adoption Assistance, Paid Holidays, and a wide selection of other voluntary benefits.</p>
Requirements:
<p>
This job requires legal authorization to work in the US. We are not currently accepting work visas.</p><p>
ObjectiveHealth is an EEO Employer and an E-Verify participant.</p></div>

Clinical Research Site Director

Mount Sinai Health System

<div><b>Description</b><div>
The Clinical Research Program Director will lead the operational, regulatory, financial, and strategic coordination of a clinical and translational immunology research portfolio focused on the development and clinical implementation of cellular therapies for non-oncologic diseases.</div><div>
This role bridges basic science, translational research, and clinical trials, with a strong emphasis on regulatory execution, including IND submissions to the FDA for both drug and cellular therapy products.</div><div></div><div><br>
The ideal candidate brings deep experience in academic clinical research environments, IND-enabling activities, and early-phase clinical trials, and is comfortable managing complex, multi-stakeholder programs involving investigators, regulatory bodies, and institutional committees.</div><div></div><div><b><br>
Why Join Us</b></div><div>
This is a unique opportunity to help build and scale a cutting-edge translational immunology program advancing cellular therapies beyond oncology into new therapeutic areas. The Clinical Research Program Director will organize a hub-and-spoke model, within the Lipschultz Precision Immunology Institute at Icahn School of Medicine (PrIISM) serving as the central coordinating hub and clinical departments/divisions functioning as disease-specific spokes.</div><b>
Responsibilities</b><div><b>
Program &amp; Portfolio Management</b></div><ul><li>
Oversee day-to-day management of translational research programs in immunology and cellular therapy</li><li>
Coordinate cross-functional teams including faculty, clinical research staff, GMP facilities, regulatory affairs, and external collaborators</li><li>
Develop and manage project timelines, milestones, budgets, and deliverables across preclinical and clinical phases</li><li>
Track progress of multiple concurrent studies and ensure alignment with institutional and sponsor priorities</li></ul><div><b>
Clinical Trials &amp; Translational Research</b></div><ul><li>
Support design, startup, and execution of early-phase (Phase I/II) clinical trials involving cellular therapies for non-cancer indications</li><li>
Coordinate activities spanning pre-clinical development, IND-enabling studies, and clinical implementation</li><li>
Interface with clinical operations teams to ensure protocol adherence, subject safety, and data compliance/ integrity</li></ul><div><b>
Regulatory Strategy &amp; IND Submissions</b></div><ul><li>
Lead preparation, coordination, and submission of Investigational New Drug (IND) applications to the FDA, including for cell and gene therapy products</li><li>
Manage regulatory documentation (e.g., protocols, investigator brochures, CMC sections, pharmacology/toxicology data)</li><li>
Serve as liaison with FDA and support responses to information requests, clinical holds, and annual reports</li><li>
Ensure compliance with GCP, GMP, and applicable regulatory requirements</li></ul><div><b>
Operational &amp; Institutional Navigation</b></div><ul><li>
Guide studies through internal review processes (e.g., IRB, biosafety, data use, and institutional committees)</li><li>
Coordinate with technology transfer, legal, and compliance offices as needed</li><li>
Establish and refine workflows to streamline translational research operations within the department</li></ul><div><b>
Collaboration &amp; Communication</b></div><ul><li>
Serve as a central point of coordination between investigators, institutional leadership, sponsors, and external partners</li><li>
Prepare reports, presentations, and updates for internal stakeholders and funding agencies</li><li>
Facilitate multidisciplinary meetings and ensure clear communication across teams</li><li>
Performs other related duties.</li></ul><b>
Qualifications</b><ul><li>
Bachelor&rsquo;s degree required. Master&rsquo;s degree in life sciences, public health, regulatory science, or a related field strongly preferred. Advanced clinical or doctoral degrees (PhD, MD, RN, or equivalent) are also strongly preferred.</li><li>
Minimum of 7 years of experience in a hospital or medical environment, preferably within human subjects or clinical trials research, including at least 3 years of supervisory experience.</li><li>
Demonstrated experience managing clinical trials, particularly early-phase or investigator-initiated studies</li><li>
Direct experience preparing and submitting IND applications to the FDA, including cellular therapy and/or biologic products</li><li><p>
Experience in translational medicine, ideally in immunology or cell therapy (non-oncology focus preferred)</p></li></ul><p></p><div><b><br>
Skills &amp; Knowledge</b></div><ul><li>
Strong understanding of FDA regulatory pathways, especially IND requirements for drugs and cell-based therapies</li><li>
Familiarity with GCP, GMP, and IND-enabling preclinical requirements</li><li>
Proven ability to manage complex, multidisciplinary programs and timelines</li><li>
Excellent organizational, communication, and stakeholder management skills</li><li><p>
Ability to navigate academic institutional processes and regulatory committees</p></li></ul><p></p><b><br>
Employer Description</b><p><b>
Strength through Unity and Inclusion</b></p><br>
<p>
The Mount Sinai Health System is committed to fostering an environment where everyone can contribute to excellence. We share a common dedication to delivering outstanding patient care. When you join us, you become part of Mount Sinai&rsquo;s unparalleled legacy of achievement, education, and innovation as we work together to transform healthcare. We encourage all team members to actively participate in creating a culture that ensures fair access to opportunities, promotes inclusive practices, and supports the success of every individual.</p><br>
<p>
At Mount Sinai, our leaders are committed to fostering a workplace where all employees feel valued, respected, and empowered to grow. We strive to create an environment where collaboration, fairness, and continuous learning drive positive change, improving the well-being of our staff, patients, and organization. Our leaders are expected to challenge outdated practices, promote a culture of respect, and work toward meaningful improvements that enhance patient care and workplace experiences. We are dedicated to building a supportive and welcoming environment where everyone has the opportunity to thrive and advance professionally. Explore this opportunity and be part of the next chapter in our history.</p><br>
<p><b>
About the Mount Sinai Health System:</b></p><br>
<p>
Mount Sinai Health System is one of the largest academic medical systems in the New York metro area, with more than 48,000 employees working across eight hospitals, more than 400 outpatient practices, more than 300 labs, a school of nursing, and a leading school of medicine and graduate education. Mount Sinai advances health for all people, everywhere, by taking on the most complex health care challenges of our time &mdash; discovering and applying new scientific learning and knowledge; developing safer, more effective treatments; educating the next generation of medical leaders and innovators; and supporting local communities by delivering high-quality care to all who need it. Through the integration of its hospitals, labs, and schools, Mount Sinai offers comprehensive health care solutions from birth through geriatrics, leveraging innovative approaches such as artificial intelligence and informatics while keeping patients&rsquo; medical and emotional needs at the center of all treatment. The Health System includes more than 9,000 primary and specialty care physicians; 13 joint-venture outpatient surgery centers throughout the five boroughs of New York City, Westchester, Long Island, and Florida; and more than 30 affiliated community health centers. We are consistently ranked by U.S. News &amp; World Report's Best Hospitals, receiving high &quot;Honor Roll&quot; status, and are highly ranked: No. 1 in Geriatrics, top 5 in Cardiology/Heart Surgery, and top 20 in Diabetes/Endocrinology, Gastroenterology/GI Surgery, Neurology/Neurosurgery, Orthopedics, Pulmonology/Lung Surgery, Rehabilitation, and Urology. New York Eye and Ear Infirmary of Mount Sinai is ranked No. 12 in Ophthalmology. U.S. News &amp; World Report&rsquo;s &ldquo;Best Children&rsquo;s Hospitals&rdquo; ranks Mount Sinai Kravis Children's Hospital among the country&rsquo;s best in several pediatric specialties. The Icahn School of Medicine at Mount Sinai is ranked No. 11 nationwide in National Institutes of Health funding and in the 99th percentile in research dollars per investigator according to the Association of American Medical Colleges. Newsweek&rsquo;s &ldquo;The World&rsquo;s Best Smart Hospitals&rdquo; ranks The Mount Sinai Hospital as No. 1 in New York and in the top five globally, and Mount Sinai Morningside in the top 20 globally.</p><br>
<p><b>
Equal Opportunity Employer</b></p><br>
<p>
The Mount Sinai Health System is an equal opportunity employer, complying with all applicable federal civil rights laws. We do not discriminate, exclude, or treat individuals differently based on race, color, national origin, age, religion, disability, sex, sexual orientation, gender, veteran status, or any other characteristic protected by law. We are deeply committed to fostering an environment where all faculty, staff, students, trainees, patients, visitors, and the communities we serve feel respected and supported. Our goal is to create a healthcare and learning institution that actively works to remove barriers, address challenges, and promote fairness in all aspects of our organization.</p><br>
<p><b>
Compensation</b></p><p>
The Mount Sinai Health System (MSHS) provides salary ranges that comply with the New York City Law on Salary Transparency in Job Advertisements. The salary range for the role is $115494 - $194020.12 Annually. Actual salaries depend on a variety of factors, including experience, education, and operational need. The salary range or contractual rate listed does not include bonuses/incentive, differential pay or other forms of compensation or benefits.</p></div>

Clinical Research Program Director in Cellular Therapy and Biologics for Non-Oncology Diseases (Immunology and Immunotherapy)

<div><b>Description</b><p>
The Administrative Director exercises management responsibility over the business and operational activities of a small to medium sized department, unit or business process. This individual is responsible for establishing short- and long-term goals and objectives in line with Mount Sinai Health System as well as ensuring compliance with federal, state and city regulatory agencies.</p><p>
The Institute for Health Equity Research (IHER) is a <b>highly collaborative, mission-driven institute</b> dedicated to transforming the future of health and health care. Our multidisciplinary teams share an <i>inquiry-to-action</i> philosophy, turning research into meaningful, real-world impact.</p><p><br>
As we continue to expand, we are seeking an <b>Administrative Director</b> who will play a pivotal role in advancing our mission. This leader will help shape and support our research operations, ensure our internationally recognized faculty can lead innovative projects that influence clinical practice, inform policy, and drive equitable health outcomes. The Administrative Director will be central to ensuring that our research infrastructure, processes, and collaborations flourish as we grow. <b>This is an exceptional opportunity for someone who:</b></p><p>
✔ Thrives in dynamic, team-oriented environments</p><p>
✔ Excels at strategic planning and operational leadership</p><p>
✔ Is passionate about supporting research programs that advance health equity</p><p>
✔ Wants to make a meaningful, lasting impact on communities and health systems</p><p>
The Administrative Director (AD) works closely with the Director and Co-Director to establish short- and long-term goals and objectives for IHER and oversees IHER&rsquo;s operational and administrative functions. The AD develops processes and procedures aligned to IHER&rsquo;s vision, oversees growth objectives, hiring and onboarding of faculty and staff, overseeing staff development, and facilitates applications for federal and non-federal funding opportunities. They work with a Finance Director to ensure financial oversight of IHER, and a Human Resources Director on faculty and staff management. The AD helps support a culture rooted in collaboration, inclusion and teamwork, and establishes mechanisms to enhance engagement and communication with internal and external stakeholders, including funders and donors. The AD establishes and monitors program metrics, prepares reports and presentations for diverse audiences and oversees IHER&rsquo;s annual symposia. They also work closely with the Director on building and maintaining relationships with the Development Office and co-managing relationships with current and potential donors to IHER.</p><p>
The successful AD is a skilled communicator, a trusted partner, leader and strategic thinker. The AD must be detailed oriented, organized and have the capacity to manage multiple diverse assignments. The ideal candidate is also an experienced supervisor with proven experience working with diverse teams. Experience working in academic research setting, administrative leadership capacity and with federal and non-federal grants mechanisms are required.</p><b><br>
Responsibilities</b><ul><li>
Provide administrative direction and coordination in the formulation, interpretation and administration of current and long-range policies, procedures and programs.</li><li>
Establish goals and objectives for IHER that are consistent with MSHS policies and federal, state &amp; local regulations.</li><li>
Collaborate with the Institute Director to develop short-term and long-range plans.</li><li>
Interpret and administer policies regarding hiring, payroll, appointments and promotions, placement and orientation of all faculty and/or staff, alongside the HR Director.</li><li>
Review and approve all reclassifications, new positions and salary increases.</li><li>
Provide oversight to management staff to ensure compliance with established practices, to implement new policies and to keep employees aware of changes and current standards.</li><li>
Ensure compliance with regulatory, insurance and ethical standards regarding research and employee safety. Identify contingency plans for potential risks.</li><li>
Encourage collaboration within IHER to effectively coordinate and implement operational activities, facilitate and encourage effective communications across functional areas.</li><li>
Plan budget needs by analyzing short and long-term program plans. Collaborate with the Finance Director to assure the completion of the annual budget and subsequent monitoring of financial status of the Institute.</li><li>
Ensure compliance with Mount Sinai Health System policies and procedures.</li></ul><br>
<b>
Qualifications</b><ul><li>
Bachelors degree; Masters degree preferred, with applicable experience</li><li>
5+ years of experience in health care finance or administration; experience in strategic planning and execution, formulating policy, building and developing financial plans, managing resources and leading successful teams.</li><li>
Excellent written and oral communications</li><li>
Exceptional attention to detail and accuracy</li><li>
Analytical and problem solving skills</li><li>
Managerial skills including budgeting and finance</li></ul><p></p><b><br>
Employer Description</b><p><b>
Strength through Unity and Inclusion</b></p>
<p>
The Mount Sinai Health System is committed to fostering an environment where everyone can contribute to excellence. We share a common dedication to delivering outstanding patient care. When you join us, you become part of Mount Sinai&rsquo;s unparalleled legacy of achievement, education, and innovation as we work together to transform healthcare. We encourage all team members to actively participate in creating a culture that ensures fair access to opportunities, promotes inclusive practices, and supports the success of every individual.</p>
<p>
At Mount Sinai, our leaders are committed to fostering a workplace where all employees feel valued, respected, and empowered to grow. We strive to create an environment where collaboration, fairness, and continuous learning drive positive change, improving the well-being of our staff, patients, and organization. Our leaders are expected to challenge outdated practices, promote a culture of respect, and work toward meaningful improvements that enhance patient care and workplace experiences. We are dedicated to building a supportive and welcoming environment where everyone has the opportunity to thrive and advance professionally. Explore this opportunity and be part of the next chapter in our history.</p>
<p><b>
About the Mount Sinai Health System:</b></p>
<p>
Mount Sinai Health System is one of the largest academic medical systems in the New York metro area, with more than 48,000 employees working across eight hospitals, more than 400 outpatient practices, more than 300 labs, a school of nursing, and a leading school of medicine and graduate education. Mount Sinai advances health for all people, everywhere, by taking on the most complex health care challenges of our time &mdash; discovering and applying new scientific learning and knowledge; developing safer, more effective treatments; educating the next generation of medical leaders and innovators; and supporting local communities by delivering high-quality care to all who need it. Through the integration of its hospitals, labs, and schools, Mount Sinai offers comprehensive health care solutions from birth through geriatrics, leveraging innovative approaches such as artificial intelligence and informatics while keeping patients&rsquo; medical and emotional needs at the center of all treatment. The Health System includes more than 9,000 primary and specialty care physicians; 13 joint-venture outpatient surgery centers throughout the five boroughs of New York City, Westchester, Long Island, and Florida; and more than 30 affiliated community health centers. We are consistently ranked by U.S. News &amp; World Report's Best Hospitals, receiving high &quot;Honor Roll&quot; status, and are highly ranked: No. 1 in Geriatrics, top 5 in Cardiology/Heart Surgery, and top 20 in Diabetes/Endocrinology, Gastroenterology/GI Surgery, Neurology/Neurosurgery, Orthopedics, Pulmonology/Lung Surgery, Rehabilitation, and Urology. New York Eye and Ear Infirmary of Mount Sinai is ranked No. 12 in Ophthalmology. U.S. News &amp; World Report&rsquo;s &ldquo;Best Children&rsquo;s Hospitals&rdquo; ranks Mount Sinai Kravis Children's Hospital among the country&rsquo;s best in several pediatric specialties. The Icahn School of Medicine at Mount Sinai is ranked No. 11 nationwide in National Institutes of Health funding and in the 99th percentile in research dollars per investigator according to the Association of American Medical Colleges. Newsweek&rsquo;s &ldquo;The World&rsquo;s Best Smart Hospitals&rdquo; ranks The Mount Sinai Hospital as No. 1 in New York and in the top five globally, and Mount Sinai Morningside in the top 20 globally.</p>
<p><b>
Equal Opportunity Employer</b></p>
<p>
The Mount Sinai Health System is an equal opportunity employer, complying with all applicable federal civil rights laws. We do not discriminate, exclude, or treat individuals differently based on race, color, national origin, age, religion, disability, sex, sexual orientation, gender, veteran status, or any other characteristic protected by law. We are deeply committed to fostering an environment where all faculty, staff, students, trainees, patients, visitors, and the communities we serve feel respected and supported. Our goal is to create a healthcare and learning institution that actively works to remove barriers, address challenges, and promote fairness in all aspects of our organization.</p><p><b><br>
Compensation</b></p><p>
The Mount Sinai Health System (MSHS) provides salary ranges that comply with the New York City Law on Salary Transparency in Job Advertisements. The salary range for the role is $95450 - $143175 Annually. Actual salaries depend on a variety of factors, including experience, education, and operational need. The salary range or contractual rate listed does not include bonuses/incentive, differential pay or other forms of compensation or benefits.</p></div>

Administrative Director - Institute for Health Equity Research

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Administrative Director - Institute for Health Equity Research