director of clinical trials

University of Oklahoma

<div></div><div><div>Job no: 492872 
Work type: Administrative Staff 
Location: Oklahoma City 
Categories: Executive/Administrative/Managerial 
</div>
<div>Pay Range: Negotiable based on qualifications.

Benefits Eligible: Yes

Work Schedule: Monday &ndash; Friday Standard / Fixed Schedule

Travel: Not required
<div>
<div><div><div>Position Introduction:

OU Health Stephenson Cancer Center is Oklahoma&rsquo;s only National Cancer Institute (NCI)-Designated Cancer Center, and one of only 73 NCI-Designated Cancer Centers in the United States. This highly competitive accreditation ensures that our patients receive the highest standard of care and have access to the most advanced cancer treatment options. At the Stephenson Cancer Center, we have an exciting new job opportunity that could be right for you!

Lead the strategy behind life changing cancer research. Are you a visionary clinical research leader ready to shape the future of oncology trials? The Clinical Trials Office (CTO) is seeking a Clinical Trials Administrative Director &ndash; Clinical Operations to provide senior level leadership over the administrative, operational, and strategic functions of our clinical research enterprise.

This is a highly influential role for an experienced professional who excels at building systems, leading people, and driving performance at scale. You&rsquo;ll partner with physicians, investigators, sponsors, and senior leadership to ensure research excellence, regulatory integrity, and sustainable growth across the CTO.

Learn more about the Stephenson Cancer Center&rsquo;s Clinical Trials Office here.

Why This Role Matters. Clinical trials are the engine of innovation in cancer care. As Administrative Director, you will help accelerate the translation of discovery into treatment by setting priorities, strengthening operations, and fostering a culture of quality, accountability, and collaboration.

What You&rsquo;ll Do:

Executive Leadership &amp; Management
<ul>
<li>Lead and manage the senior Clinical Trials Office management team</li>
<li>Establish the strategic mission, vision, and operational direction of the CTO</li>
<li>Conduct senior management meetings to promote transparency, collaboration, and alignment with leadership and physicians</li>
</ul>
Strategic &amp; Program Planning
<ul>
<li>Monitor global clinical research activity and performance across specialties</li>
<li>Establish research priorities and develop action plans to address operational or compliance challenges</li>
<li>Participate in organizational decision making and policy development impacting clinical research</li>
</ul>
Policy, Procedure &amp; Governance
<ul>
<li>Direct the comprehensive development, implementation, and maintenance of CTO policies and procedures</li>
<li>Ensure standardized, compliant research operations across the enterprise</li>
</ul>
Performance, Metrics &amp; Evaluation
<ul>
<li>Establish, evaluate, and monitor performance and productivity metrics for each clinical specialty</li>
<li>Use data driven insights to guide operational improvements and strategic planning</li>
</ul>
Conflict Resolution &amp; Stakeholder Engagement
<ul>
<li>Serve as liaison between investigators and sponsors to resolve issues related to protocol conduct</li>
<li>Foster strong relationships with physicians, researchers, sponsors, and institutional partners</li>
</ul>
Quality Assurance &amp; Auditing
<ul>
<li>Oversee the internal Quality Assurance program and external affiliate audits</li>
<li>Ensure corrective action plans are developed, implemented, and monitored</li>
</ul>
Research Informatics &amp; Systems
<ul>
<li>Collaborate with the CTO Informatics Coordinator to develop and optimize clinical trial management systems</li>
<li>Ensure systems support regulatory, nursing, and data management functions and meet federal and state reporting requirements</li>
</ul>
Financial &amp; Business Planning
<ul>
<li>Partner with Finance and Administration to develop strategic financial and business plans for the CTO</li>
<li>Support sustainable growth and responsible resource allocation 
 
Cancer Reporting &amp; Compliance</li>
<li>Collaborate with administration to ensure accurate clinical trial reporting in compliance with federal and state requirements</li>
</ul>
Other Responsibilities
<ul>
<li>Perform additional duties as needed to successfully fulfill the functions and mission of the position 
 
Why Join Us?</li>
<li>Play a central role in advancing oncology clinical research</li>
<li>Influence institutional strategy at the highest levels</li>
<li>Work alongside nationally recognized investigators and clinical teams</li>
<li>Lead innovation that directly impacts patient access to cutting edge therapies</li>
</ul>
Ready to lead the operational engine behind breakthrough cancer trials? Apply today and help define the future of clinical research through strategic leadership and operational excellence.

View full job description.</div></div><div> 
<div>
Required Education and Experience:
<ul>
<li>Bachelor's degree in Nursing or Health Related Field</li>
<li>Minimum seven years clinical research experience with five years in a supervisory role over research regulatory, data management and clinical research nursing cores.</li>
</ul>
Required Certifications and Licenses:

None
</div>
</div> 
</div></div>Hiring Contingent Upon a Background Check: Yes
</div>
Advertised: 05 May 2026 Central Daylight Time 
Applications close: 03 Aug 2026 Central Daylight Time</div>

Clinical Trials Administrative Director - Clinical Operations

Merck

<div>Job Description
Job Description:
The Clinical Director (Principal Scientist) has primary responsibility for planning and directing clinical research activities involving new or marketed medicines in the Immunology therapeutic area. Our company's Immunology medicines span all phases of clinical development (pre-clinical to post-licensure). The Clinical Director may manage the entire cycle of clinical development for their assigned studies including study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication.
Role Responsibilities:
Specifically, the Clinical Director may be responsible for:<ul><li>
Planning clinical trials (designing, collaborating on operational plans, etc.) based on the clinical development strategy</li><li>
Medical oversight and overall conduct of ongoing or new clinical trials for investigational or marketed drugs</li><li>
Analyzing and summarizing clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical study reports, or publication</li><li>
Participating in internal and joint internal/external research project teams relevant to the development of new compounds, and the further study of marketed compounds</li><li>
Supporting business development assessments of external opportunities</li></ul>
The Clinical Director may:<ul><li>
Actively engage with other functional areas in support of study execution</li><li>
Work closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects; and</li><li>
Assist the team in ensuring that other colleagues are informed of the progress of studies of our company and competitors' drugs, and</li><li>
Provide expert opinion, internally and externally, on relevant scientific questions within their responsibility.</li></ul>
The Clinical Director is responsible for maintaining a strong scientific fund of knowledge by:<ul><li>
Maintaining awareness of scientific developments within their area of expertise, in terms of new scientific findings, research methodologies</li><li>
Identifying scientifically and operationally strong investigators who can assist in the development of our company's investigational and marketed drugs</li><li>
Establishing communications with prominent clinical investigators in their particular field of interest, particularly those who will be willing and able to assist in the evaluation of our company's drugs</li><li>
Attending appropriate scientific meetings to maintain their competency and to maintain awareness of research activities in their area of responsibility.</li></ul>
To accomplish these goals, the Clinical Director may:<ul><li>
Author detailed development documents, presentations, budgets, and position papers for internal and external audiences</li><li>
Facilitate collaborations with external researchers around the world</li><li>
Travel on company business about twenty (20) percent of the time to manage future or ongoing clinical research projects.</li></ul>
Education:<ul><li>
M.D or M.D./Ph.D.</li></ul>
Required Experience and Skills:<ul><li>
Must have experience in industry or senior faculty in academia</li><li>
Minimum of 3 years of clinical medicine experience</li><li>
Minimum of 1 year of industry experience in drug development or biomedical research experience in academia</li><li>
Demonstrated record of scientific scholarship and achievement</li><li>
Proven track record in clinical medicine and background in biomedical research</li><li>
Strong interpersonal skills, as well as the ability to function in a team environment</li><li>
Provide expert opinion, internally and externally, on relevant scientific questions within their responsibility.</li></ul>
Preferred Experience and Skills:<ul><li>
Board Certified or Eligible in Rheumatology or related discipline</li><li>
Prior specific experience in clinical research and prior publication</li></ul>
Required Skills:
Allergy and Immunology, Clinical Development, Clinical Documentation, Clinical Immunology, Clinical Medicine, Clinical Reporting, Clinical Research, Clinical Trial Planning, Clinical Trials, Clinical Trial Support, Drug Development, Ethical Standards, Leadership, Regulatory Requirements, Rheumatology
Preferred Skills: 
US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
EEOC Know Your Rights
EEOC GINA Supplement
We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another&rsquo;s thinking and approach problems collectively.
Learn more about your rights, including under California, Colorado and other US State Acts
U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as &ldquo;remote&rdquo;.
The salary range for this role is
$255,800.00 - $402,700.00
This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee&rsquo;s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.
The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.
You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.
San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles&rsquo; Fair Chance Initiative for Hiring Ordinance
Search Firm Representatives Please Read Carefully 
Merck &amp; Co., Inc., Rahway, NJ, USA, also known as Merck Sharp &amp; Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
Regular
Relocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
Not Applicable
Shift:
Valid Driving License:
Hazardous Material(s):
Job Posting End Date:
05/5/2026<ul><li>A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. 
</li></ul> 
Requisition ID:R389093</div>

Clinical Director (Principal Scientist), Clinical Research, Immunology - Rheumatology

ObjectiveHealth

<div>Description:

Clinical Research Site Director
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.
Who We Are
ObjectiveHealth is a clinical research company that uses proprietary technology to:<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>
All with the goal of Improving Patient Outcomes at the point of care.
We want you to join us in doing just that.
Who You Are<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>
What Success Looks Like for This Role<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>
What We Offer
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.
Requirements:

This job requires legal authorization to work in the US. We are not currently accepting work visas.
ObjectiveHealth is an EEO Employer and an E-Verify participant.</div>

Clinical Research Site Director

Mount Sinai Health System

<div>Description<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> 
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> 
Why Join Us</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>
Responsibilities<div>
Program &amp; Portfolio Management</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>
Clinical Trials &amp; Translational Research</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>
Regulatory Strategy &amp; IND Submissions</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>
Operational &amp; Institutional Navigation</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>
Collaboration &amp; Communication</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>
Qualifications<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>
Experience in translational medicine, ideally in immunology or cell therapy (non-oncology focus preferred)</li></ul><div> 
Skills &amp; Knowledge</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>
Ability to navigate academic institutional processes and regulatory committees</li></ul> 
Employer Description
Strength through Unity and Inclusion 

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. 

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. 

About the Mount Sinai Health System: 

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. 

Equal Opportunity Employer 

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. 

Compensation
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.</div>

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

Sanofi

<div>Job title: Clinical Research Director (CRD)
Location: Cambridge, MA / Morristown, NJ 
About the job
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.
Our Team:
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). 
The Clinical Research Director (CRD) is the medical expert in the Development of R&amp;D programs. 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. 
Our Project:
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.
About Sanofi
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.
Main responsibilities:
The role of the CRD is to:<ul><li>
Provide medical expertise in the Study team to conduct the clinical studies from early phases to LCM programs</li><li>
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</li><li>
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;)</li><li>
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</li><li>
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.</li><li>
Be the medical reference in the Clinical Study team, ensuring the medical relevance of the clinical data</li></ul>
Key responsibilities include:
Leading the clinical development plan strategies<ul><li>
Responsible for the clinical development plans and clinical sections of integrated development plans (IDP)</li><li>
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</li><li>
Raise study or project-level issues to the project head and propose related corrective action plans</li><li>
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</li><li>
Collaborates with external partners, regulators, scientific experts and internal stakeholders
</li><li>Provide operational expertise to project clinical sub team, as needed</li><li>
Evaluates relevant medical literature and status from competitive products</li></ul>
Lead, Support and oversee the execution of clinical development and studies
<ul><li>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)
</li><li>Develop the abbreviated protocol, the final protocol and protocol amendments
</li><li>Develop/review the Core Study Informed Consent Form (CSICF)</li><li>
Develop/review Study committee Charters</li><li>
Collaborate on key medical and clinical questions with the Global feasibility manager to prepare and interpret feasibility and competitive intelligence results
</li><li>Review and provide clinical input across different study documents Vendors RFPs, e-CRF, eCOA etc</li><li>
Provide medical/clinical input to study-related documents such as study plans e.g. Study risk management plan, Monitoring and centralized monitoring plans
</li><li>Participate in the elaboration of training material and presentations at the investigator meetings/local teams trainings</li><li>
Answer to medical questions raised by HA, EC/IRBs, sites</li><li>
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;)
</li><li>Ensure trial master file documents readiness and availability, and mandatory trainings linked to the clinical function</li><li>
Lead the study specific committees (IDMC, steering com, adjudication &hellip;) with operational support
</li><li>Co-Develop the SAP in collaboration with biostatistical team</li><li>
Responsible for key results preparation</li><li>
Develop/Review the clinical study report
</li></ul>Responsibilities related to regulatory and safety documents and meetings<ul><li>
Review and/or contribute in the clinical section of the Investigator&rsquo;s brochure, CTA, IND, DSUR, DRMP, RMP</li><li>
Write/review the clinical sections of the BLA/CTD, Briefing packages for regulatory meetings, PSP/PIP</li><li>
Ensures clinical data meets all necessary regulatory standards</li><li>
Collaborates with the Patient Safety GSO to detect and document any safety signal</li><li>
Participates in Advisory Committee preparation</li></ul>
Scientific Data evaluation and authorship<ul><li>
Participate and author manuscripts and abstracts
</li><li>Establish and maintains appropriate collaborations with knowledge experts or advisory boards</li><li>
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</li></ul> 
About you
Experience:<ul><li>
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.</li></ul>
Soft skills:<ul><li>
Very good communication skills (verbal and written) for interactions across functional areas and for interactions with key regulatory agencies</li><li>
Excellent problem solving capability</li><li>
Demonstrated capability to challenge decision and status quo with a risk-management approach</li><li>
Ability to negotiate to ensure operational resources are available for continued clinical conduct</li><li>
Very good teaching skills, demonstrated ability to assist and train others</li><li>
Ability to work within a matrix model</li><li>
International/ intercultural working skills</li><li>
Open-minded to apply new digital solutions</li></ul>
Technical skills:<ul><li>
Understanding of pharmaceutical product development and life cycle management</li><li>
Very good Scientific and medical/clinical expertise</li><li>
Very good expertise in clinical development and methodology of clinical studies</li></ul>
Education:<ul><li>
MD (Doctor of Medicine) or equivalent patient care-related medical degree (DO, international equivalents, etc.) required</li></ul>
Languages:<ul><li>
English fluent (spoken and written)</li></ul>
Why Choose Us?<ul><li>
Bring the miracles of science to life alongside a supportive, future-focused team.</li><li>
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.</li><li>
Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.</li><li>
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.</li></ul>
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.
#GD-SA
 
#LI-SA
#LI-Onsite
#vhd
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.</div>

Clinical Research Director, I&I

<div>Job title: Clinical Research Director - Rare Diseases
Location: Cambridge, MA / Morristown, NJ
About the Job
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.
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.
About Sanofi 
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. 
Main Responsibilities:<ul><li>
Create clinical development strategy and plans for one or more assets</li><li>
Lead and coordinate cross-functional teams to design, implement, and execute clinical development plans and studies</li><li>
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</li><li>
Advance the clinical development plan through internal management review</li><li>
Lead a clinical sub team to design clinical studies and to create study protocols</li><li>
Execute the clinical development plan in close collaboration with clinical operations</li><li>
Advance scientific and clinical knowledge in rare diseases</li><li>
Incorporate new trial, scientific and digital methodologies</li><li>
Pro-actively progress study execution</li><li>
Oversee the execution of clinical studies in compliance with internal SOPs, GCP, ICH guidelines and other regulations</li><li>
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</li><li>
Engage with health authorities (contribute to health authority submissions (such as new drug application) and timely response to regulatory reviews)</li><li>
Serve as a medical expert and provide strategic input to early-stage programs
</li><li>Collaborate with external experts, key opinion leaders, and investigators to advance clinical research</li><li>
Represent Sanofi at scientific conferences and regulatory meetings</li></ul>
Scientific and Technical Expertise:<ul><li>
Has and maintains deep scientific, technical and clinical expertise in the therapeutic area</li><li>
Understands and keeps updated with the pre-clinical, clinical pharmacology and data relevant to the molecule of interest</li><li>
Critically reads and evaluates relevant medical literature with deep understanding of the data and status from competitive products</li><li>
Maintains visibility within the Therapy therapeutic area to maintain credibility with internal and external stakeholders</li></ul>
On Clinical Development, the CRD:<ul><li>
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</li><li>
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</li><li>
Provides clinical input to the Target Product Profile</li><li>
Adjusts and updates the clinical strategy when necessary according to the project progression and information available</li><li>
Contributes to the life cycle management strategy for the project whenever appropriate</li></ul>
The CRD is representative for Clinical Development:<ul><li>
at the Project Team</li><li>
in meetings with Regulatory Agencies</li><li>
in Steering Committees (SC) and Data Monitoring Committees (DMC)</li><li>
at the Benefit Risk Assessment Committee</li><li>
at the Submission Task Force. Provides clinical input and reviews the product information (Summary of Product Characteristics or equivalent)</li></ul>
The CRD generates documents:<ul><li>
Generates the Clinical Development Plan</li><li>
Prepares the clinical part of meeting requests and briefing packages for meetings with Regulatory agencies</li><li>
Generates the extended synopsis for clinical trials and reviews the protocols and protocol amendments prepared by the Clinical Study Director (CSD)</li><li>
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</li><li>
Reviews and when appropriate approves the committees charters</li><li>
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</li><li>
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</li><li>
In charge of the medical/clinical assessment of license-in opportunities</li></ul>
About You
Experience / Skills:<ul><li>
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</li><li>
Experience/enthusiasm in advancing assets from discovery into clinical development (experience in pharma or academia)</li><li>
Have experience in novel approaches to translational medicine</li><li>
Demonstrate problem solving skills</li><li>
Understand and keep updated with the pre-clinical, clinical pharmacology and clinical data relevant to the molecule of interest and the respective therapeutic area</li><li>
Strong leadership skills with the ability to influence and collaborate effectively in a matrix environment</li><li>
Excellent communication and presentation skills, with the ability to articulate complex scientific concepts to diverse audiences</li><li>
Proven track record of scientific publications and presentations at international conferences</li></ul>
Why Choose Us?<ul><li>
Bring the miracles of science to life alongside a supportive, future-focused team.</li><li>
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.</li><li>
Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.</li><li>
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.</li></ul>
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.
#GD-SA
 
#LI-SA
#LI-Onsite
#vhd
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.</div>

Clinical Research Director - Rare Diseases

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