7 Clinical Development Director jobs in Port Colden
Executive Director, Clinical Development
Posted 23 days ago
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Job Description
The Executive Director leads late-stage clinical development activities for one or more compounds in development. This position requires a strategic mindset and flexible thinking to enable design and execution of the clinical development strategy while providing medical and scientific leadership for Celldex sponsored protocols. The Executive Director is expected to function at the highest level with multiple responsibilities: overseeing study patient safety, playing key roles in data collection, data cleaning and data analysis; training internal and study site staffs on study procedures, addressing study related medical and protocol issues; providing medical expertise and medical support including feasibility assessments, medical training, and medical/clinical input for the design of study protocols and clinical development programs; ensuring the medical and scientific quality of clinical trial protocols, case report forms, and clinical trial reports; providing medical and strategic input into the design of clinical development programs and study protocols.
Responsibilities
- Oversee the clinical development of multiple programs, including planning, execution, and monitoring of phase 1/2/3 clinical trials
- Collaborate with the regulatory team to develop clinical trial protocols, briefing documents, and other regulatory and regulatory documents (IND, BLA, NDA, annual reports, etc.)
- Ensure all clinical development activities are performed on time, within budget, and to the highest standards of quality
- Provides medical support to clinical operations, regulatory and preclinical programs
- Medical monitoring with oversight of patient safety
- Training and collaboration with staff within the areas of responsibility
- Assesses external clinical research proposals involving company products and manuscripts that are being prepared for publication
- Work with external partners, including CROs, academic institutions, and key opinion leaders (KOLs), to enhance the development programs and ensure successful execution of clinical trials.
- Lead the interpretation of clinical trial data and collaborate on the preparation of clinical study reports, presentations, and publications for scientific conferences and peer-reviewed journals
- MD, with specialization in one or more of the following preferred: allergy/dermatology/immunology/pulmonary
- Minimum of 8 years of experience in a clinical development at a biotechnology or pharmaceutical company
- Demonstrated experience in clinical research, including creating clinical development plans, and designing, planning and monitoring clinical trials, particularly Phases 2-3
- Clinical development experience with biologics or small molecule agents addressing immunologic and allergic diseases preferred, such as chronic urticaria, allergic asthma, mast cell diseases
- Experience with preparing clinical sections of regulatory submissions (e.g., NDAs and INDs) preferred
- Strong experience reviewing and interpreting study data/reports
- The ability to function on an even scientific and clinical level with investigators and experts
- Demonstrated ability to work effectively in cross-functional teams
- Excellent oral and written communication skills
- Excellent interpersonal and organizational skills and attention to details
- Experience with FDA/EMA processes (IND filing, NDA filings) desirable
- Strong knowledge of MS Word, Excel, and
- Strong written and interpersonal skills
Compensation
The expected base salary range for this position is $340,000 to $370,000.
We are committed to compensating employees equitably based on several factors including experience, education, licensure/certifications, skill level, location of the position, and availability of similar talent in a competitive market.
Compensation for this role includes base salary, annual discretionary bonus, long term incentive, 401(K) plan with employer contribution, health care and other insurance benefits (for employee and family), paid holidays, vacation, and sick days. A summary of our benefits can be found on our careers page.
Celldex is proud to be an equal opportunity employer that strives to foster a culture of diversity, equity, and inclusion. We are committed to promoting a diverse environment through development, recruiting and community outreach.
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Senior Director, Early Development Clinical Leader Ophthalmology
Posted 6 days ago
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Job Description
Discovery & Pre-Clinical/Clinical Development
**Job Sub** **Function:**
Clinical Development & Research - MD
**Job Category:**
Scientific/Technology
**All Job Posting Locations:**
Cambridge, Massachusetts, United States of America, La Jolla, California, United States (inactive), Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America
**Job Description:**
At Johnson & Johnson,?we believe health is everything. Our strength in healthcare innovation empowers us to build a?world where complex diseases are prevented, treated, and cured,?where treatments are smarter and less invasive, and?solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ?
**POSITION SUMMARY:**
The incumbent will serve as a Clinical Leader in Ophthalmology, Neuroscience, building the Translational Medicine and Early Development Plan and leading the clinical development strategy for early-stage compound(s), in collaboration with Ophthalmology Discovery, Biomarkers, Clinical Development, and other functional partners. This position is accountable for the medical oversight, conduct, and analysis of the appropriate first in human (FIH), proof of pharmacology (POP), proof of mechanism (POM), and proof of concept (POC) studies for NME early development programs and mechanistic trials and clinical pharmacology studies supporting all phases of development for the ophthalmology portfolio.
**ESSENTIAL FUNCTIONS:**
+ Leading the early development clinical team in the timely completion, content, and quality of key development deliverables including protocols, reports and submissions to health agencies
+ Close collaboration with discovery on target identification, biomarker strategies, and NME criteria
+ Overseeing active medical and scientific contribution to matrixed cross-functional Early Compound Development Teams and Clinical Teams
+ Formulation and implementation of early Clinical Development Plans, including trial design and endpoints · Working with functional partner leadership (e.g., Global Clinical Operations (GCO), Regulatory, Global Medical Safety) to achieve common goals
+ Presenting and/or responding to questions at meetings with Health Authorities, including FDA advisory committee meetings and/or CHMP presentations
+ Participating in formulating our strategy as a key leader in the Ophthalmology Disease Area Stronghold Leadership Team
+ Providing key input into due diligence activities for Business Development opportunities
+ Collaborating across disease areas and therapeutic areas to optimize the reach of Johnson & Johnson's differentiated scientific expertise and capabilities
+ Participating in cross-departmental or cross-functional projects with broad Johnson & Johnson impact
+ Building and maintaining relationships with key opinion leaders
+ Provides key input into diligence activities
_This is not an exhaustive, comprehensive listing of job functions. May perform other duties as assigned._
**Education and Experience:**
+ MD (or equivalent) is required. Board certification in Ophthalmology is preferred
+ Detailed and thorough understanding of retinal disorders, including inherited retinal diseases, retinal vascular diseases and degenerative diseases of the macula is required.
+ Additional education: Significant academic or pre-clinical research or related experience is especially desirable. Expertise in clinical drug development including demonstrated ability to develop clinical development plans meeting the highest standards is required. Ability to interface effectively with discovery, preclinical, and late clinical development is required. Energy and enthusiasm are essential. Experience working in a Matrix environment is required.
+ Excellent oral and written communication and presentation skills are required. The ability to work with cross-functional teams in a matrix environment is required.
+ Up to 20% annual travel (domestic and international) may be required.
**Required Technical Knowledge and Skills:**
+ Fluent in written and spoken English
+ Working knowledge of the use of Microsoft suite of software products including Excel and Word
+ Experience and knowledge of Good Clinical Practices and regulatory requirements for the conduct of clinical trials and for the appropriate contributions to regulatory filings
+ Exceptional analytical and critical thinking skills, with the ability to translate complex data (financial/operational) into actionable insights for strategic decision making.
+ Exceptional problem-solving skills with the capacity to anticipate risks, to develop creative solutions and to meet objectives.
+ Demonstrated ability to develop deep insights (e.g., big picture thinking) based on data analysis and interpretation.
+ Results oriented, able to think creatively, critically, and proactively, to drive innovative solutions.
+ Breath of experience in leading people of varying levels via coaching and open conversations to reach their full potential, while also providing support and guidance during periods of poor performance.
**Special Training or Certification:**
+ Board certification in Ophthalmology is preferred
The anticipated base pay range for this position is $226,000 to $391,000 USD.
The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
Employees may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, long term incentives, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans. Additional information can be found through the link below. For additional general information on Company benefits, please go to: - Johnson & Johnson, we're on a mission to change the trajectory of health for humanity. That starts by creating the world's healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional, and financial health of our employees and the ones they love. As such, depending on location and subject to local legislation, candidates offered employment may be required to show proof of COVID-19 vaccination or, in certain countries, secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work. If you are invited to interview for the position, your recruiter will advise on the vaccine requirement status in your geographic location.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
For more information on how we support the whole health of our employees throughout their wellness, career, and life journey, please visit
Senior Director, Early Development Clinical Leader Ophthalmology
Posted 8 days ago
Job Viewed
Job Description
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at no-style="text-align:left;">Job Function:
Discovery & Pre-Clinical/Clinical DevelopmentJob Sub Function:
Clinical Development & Research – MDJob Category:
Scientific/TechnologyAll Job Posting Locations:
Cambridge, Massachusetts, United States of America, La Jolla, California, United States (inactive), Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of AmericaJob Description:
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at SUMMARY:
The incumbent will serve as a Clinical Leader in Ophthalmology, Neuroscience, building the Translational Medicine and Early Development Plan and leading the clinical development strategy for early-stage compound(s), in collaboration with Ophthalmology Discovery, Biomarkers, Clinical Development, and other functional partners. This position is accountable for the medical oversight, conduct, and analysis of the appropriate first in human (FIH), proof of pharmacology (POP), proof of mechanism (POM), and proof of concept (POC) studies for NME early development programs and mechanistic trials and clinical pharmacology studies supporting all phases of development for the ophthalmology portfolio.
ESSENTIAL FUNCTIONS:
- Leading the early development clinical team in the timely completion, content, and quality of key development deliverables including protocols, reports and submissions to health agencies
- Close collaboration with discovery on target identification, biomarker strategies, and NME criteria
- Overseeing active medical and scientific contribution to matrixed cross-functional Early Compound Development Teams and Clinical Teams
- Formulation and implementation of early Clinical Development Plans, including trial design and endpoints · Working with functional partner leadership (e.g., Global Clinical Operations (GCO), Regulatory, Global Medical Safety) to achieve common goals
- Presenting and/or responding to questions at meetings with Health Authorities, including FDA advisory committee meetings and/or CHMP presentations
- Participating in formulating our strategy as a key leader in the Ophthalmology Disease Area Stronghold Leadership Team
- Providing key input into due diligence activities for Business Development opportunities
- Collaborating across disease areas and therapeutic areas to optimize the reach of Johnson & Johnson’s differentiated scientific expertise and capabilities
- Participating in cross-departmental or cross-functional projects with broad Johnson & Johnson impact
- Building and maintaining relationships with key opinion leaders
- Provides key input into diligence activities
This is not an exhaustive, comprehensive listing of job functions. May perform other duties as assigned.
Education and Experience:
- MD (or equivalent) is required. Board certification in Ophthalmology is preferred
- Detailed and thorough understanding of retinal disorders, including inherited retinal diseases, retinal vascular diseases and degenerative diseases of the macula is required.
- Additional education: Significant academic or pre-clinical research or related experience is especially desirable. Expertise in clinical drug development including demonstrated ability to develop clinical development plans meeting the highest standards is required. Ability to interface effectively with discovery, preclinical, and late clinical development is required. Energy and enthusiasm are essential. Experience working in a Matrix environment is required.
- Excellent oral and written communication and presentation skills are required. The ability to work with cross-functional teams in a matrix environment is required.
- Up to 20% annual travel (domestic and international) may be required.
Required Technical Knowledge and Skills:
- Fluent in written and spoken English
- Working knowledge of the use of Microsoft suite of software products including Excel and Word
- Experience and knowledge of Good Clinical Practices and regulatory requirements for the conduct of clinical trials and for the appropriate contributions to regulatory filings
- Exceptional analytical and critical thinking skills, with the ability to translate complex data (financial/operational) into actionable insights for strategic decision making.
- Exceptional problem-solving skills with the capacity to anticipate risks, to develop creative solutions and to meet objectives.
- Demonstrated ability to develop deep insights (e.g., big picture thinking) based on data analysis and interpretation.
- Results oriented, able to think creatively, critically, and proactively, to drive innovative solutions.
- Breath of experience in leading people of varying levels via coaching and open conversations to reach their full potential, while also providing support and guidance during periods of poor performance.
Special Training or Certification:
- Board certification in Ophthalmology is preferred
The anticipated base pay range for this position is $226,000 to $391,000 USD.
The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.
Employees may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, long term incentives, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans. Additional information can be found through the link below. For additional general information on Company benefits, please go to: - Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional, and financial health of our employees and the ones they love. As such, depending on location and subject to local legislation, candidates offered employment may be required to show proof of COVID-19 vaccination or, in certain countries, secure an approved acc ommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work. If you are invited to interview for the position, your recruiter will advise on the vaccine requirement status in your geographic location.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
For more information on how we support the whole health of our employees throughout their wellness, career, and life journey, please visit no-style="text-align:inherit;">
Clinical Research Director
Posted 1 day ago
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Job Description
Job Title: Clinical Research Director Location : Morristown, NJ Cambridge, MA About the Job Ready to push the limits of what’s possible? Join Sanofi in one of our corporate functions and you can play a vital part in the performance of our entire business while helping to make an impact on millions around the world. The Clinical Research Director (CRD), Immunology & Inflammation (I&I) Therapeutic Area 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 for immunology in Dermatology, incorporate new methodologies and pro-actively Progress study execution. We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started? Main Responsibilities: Create the clinical development strategy for one or more assets and document it in the clinical development plan in collaboration with the global project team and internal partners such as clinical operations, translational medicine, regulatory affairs, biostatistics, drug discovery, drug safety, marketing. Advance the CDP through internal management review. Leads a clinical subteam to design clinical studies and to create an abbreviated and full clinical study protocol. Oversee the execution of clinical studies in compliance with internal SOPs, GCP, ICH guidelines and other regulations. Review documents supporting clinical development such as Investigator’s brochure, regulatory documents for IND/CTA, clinical sections of integrated development plans, and submission dossiers for regulatory approval. Support drug registrations (contribution to submission dossiers label draft, regulatory response during the review process, Advisory Committee preparation). Contribute to data review, interpretation and publication of clinical study results. Represent Clinical Development at Health Authorities and incorporating advise into development strategy. Maintain or establish interaction with external scientific and clinical communities and to incorporate pertinent advice and learnings into the internal program. Align company position on clinical strategy with partner in alliance projects. translate biology into clinic in close collaboration with research and translational medicine. evaluate clinical aspects of business development opportunities as needed. apply high ethical standards and work with integrity. Scientific and Technical Expertise: This position requires a strong scientific and clinical foundation in dermatology. Advanced leadership skills and the ability to effectively collaborate with external partners, regulators, and diverse internal stakeholders and collaborators are essential prerequisites. Be experienced in advancing assets from discovery into clinical development. Have experience in novel approaches in translational medicine. Have and maintain deep scientific, technical and clinical knowledge in Dermatology. Demonstrated problem solving skills. Understand and keep updated with the pre-clinical, clinical pharmacology and clinical data relevant to the molecule of interest and the respective therapeutic area. Be able to translate current understanding of disease pathogenesis into functional consequences and clinical outcome. Have an understanding of novel biomarker and precision medicine approaches, novel clinical trial designs, endpoints and statistical methods. Understand the competitive environment. Have established connections within the medical field of their expertise. Have a credible publication record. About You Basic Qualifications: Medical Doctor. Should be board certified or equivalent in dermatology or allergy/immunology. Must have completed education and training at a medical school that meets the requirements of the Liaison Committee on Medical Education (LCME) or equivalent. More than 5 years of clinical or scientific and/or more than >10 years industry experience within the field of dermatology. Strong scientific and academic background within clinical research, pharmaceutical experience or experimental medicine experience in the respective therapeutic area preferred. Knowledge of drug development preferred. Strong interpersonal, communication, presentation, negotiation and networking skills in a cross-cultural global environment. Performance oriented with ability to work along agreed timelines and a focus on strategy and execution. Outstanding communicator. Excellent problem-solving, conflict-resolution and decision-making skills. Fluent in English (verbal and written communication). Why Choose Us? Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. 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’ gender-neutral parental leave. 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 canbe found here.
Clinical Research Director
Posted 6 days ago
Job Viewed
Job Description
**Location** : Morristown, NJ Cambridge, MA
**About the Job**
Ready to push the limits of what's possible? Join Sanofi in one of our corporate functions and you can play a vital part in the performance of our entire business while helping to make an impact on millions around the world.
The Clinical Research Director (CRD), Immunology & Inflammation (I&I) Therapeutic Area 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 for immunology in Dermatology, incorporate new methodologies and pro-actively progress study execution.
We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?
**Main Responsibilities:**
+ Create the clinical development strategy for one or more assets and document it in the clinical development plan in collaboration with the global project team and internal partners such as clinical operations, translational medicine, regulatory affairs, biostatistics, drug discovery, drug safety, marketing.
+ Advance the CDP through internal management review.
+ Leads a clinical subteam to design clinical studies and to create an abbreviated and full clinical study protocol.
+ Oversee the execution of clinical studies in compliance with internal SOPs, GCP, ICH guidelines and other regulations.
+ Review documents supporting clinical development such as Investigator's brochure, regulatory documents for IND/CTA, clinical sections of integrated development plans, and submission dossiers for regulatory approval.
+ Support drug registrations (contribution to submission dossiers label draft, regulatory response during the review process, Advisory Committee preparation).
+ Contribute to data review, interpretation and publication of clinical study results.
+ Represent Clinical Development at Health Authorities and incorporating advise into development strategy.
+ Maintain or establish interaction with external scientific and clinical communities and to incorporate pertinent advice and learnings into the internal program.
+ Align company position on clinical strategy with partner in alliance projects.
+ translate biology into clinic in close collaboration with research and translational medicine.
+ evaluate clinical aspects of business development opportunities as needed.
+ apply high ethical standards and work with integrity.
**Scientific and Technical Expertise:**
+ This position requires a strong scientific and clinical foundation in dermatology. Advanced leadership skills and the ability to effectively collaborate with external partners, regulators, and diverse internal stakeholders and collaborators are essential prerequisites.
+ Be experienced in advancing assets from discovery into clinical development.
+ Have experience in novel approaches in translational medicine.
+ Have and maintain deep scientific, technical and clinical knowledge in Dermatology.
+ Demonstrated problem solving skills.
+ Understand and keep updated with the pre-clinical, clinical pharmacology and clinical data relevant to the molecule of interest and the respective therapeutic area.
+ Be able to translate current understanding of disease pathogenesis into functional consequences and clinical outcome.
+ Have an understanding of novel biomarker and precision medicine approaches, novel clinical trial designs, endpoints and statistical methods.
+ Understand the competitive environment.
+ Have established connections within the medical field of their expertise.
+ Have a credible publication record.
**About You**
**Basic Qualifications:**
+ Medical Doctor. Should be board certified or equivalent in dermatology or allergy/immunology.
+ Must have completed education and training at a medical school that meets the requirements of the Liaison Committee on Medical Education (LCME) or equivalent.
+ More than 5 years of clinical or scientific and/or more than >10 years industry experience within the field of dermatology.
+ Strong scientific and academic background within clinical research, pharmaceutical experience or experimental medicine experience in the respective therapeutic area preferred.
+ Knowledge of drug development preferred.
+ Strong interpersonal, communication, presentation, negotiation and networking skills in a cross-cultural global environment.
+ Performance oriented with ability to work along agreed timelines and a focus on strategy and execution.
+ Outstanding communicator. Excellent problem-solving, conflict-resolution and decision-making skills.
+ Fluent in English (verbal and written communication).
**Why Choose Us?**
+ Bring the miracles of science to life alongside a supportive, future-focused team.
+ Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
+ Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
+ 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' gender-neutral parental leave.
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
**Pursue** **_progress_** **, discover** **_extraordinary_**
Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video ( and check out our Diversity Equity and Inclusion actions at sanofi.com ( !
_US and Puerto Rico Residents Only_
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; 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.
_North America Applicants Only_
The salary range for this position is:
$201,000.00 - $335,000.00
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK ( .
Global Terms & Conditions and Data Privacy Statement ( is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting or via our movie We are Sanofi ( an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live.
All in for Diversity, Equity and Inclusion at Sanofi - YouTube (
Senior Clinical Research Director, Ophthalmology
Posted 6 days ago
Job Viewed
Job Description
**Location** : Cambridge, MA Morristown, NJ
**About the Job**
Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress.
The Senior Clinical Research Director (CRD) is an **expert clinical lead for one or several indications in the Development of an R&D program** and is responsible for leading clinical team(s) to deliver successful clinical trials for novel therapeutics for Ophthalmologic Diseases. The role requires clinical leadership, organization skills, strategically and operationally focused, resourceful individual with capacity to arbitrate to create synergies within the team and with external stakeholders, very good emotional intelligence, self-motivation, solid analytical skills, and the ability deliver to multiple operational tasks.
We are looking for individuals with drive, curiosity, scientific mindset, and appreciation of teamwork with a diverse group of internal and external experts.
We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people's lives. We're also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?
**Main Responsibilities:**
The role of the Senior CRD is to:
+ Provide ophthalmology focused medical and scientific expertise to the cross functional project team to conduct the clinical studies from early phases to LCM programs
+ Establish clinical development strategy and lead clinical team, collaborate with other medical and clinical scientific experts, clinical development scientists, in the project in collaboration with the Global safety Officer, Regulatory Strategist and other key functional representatives to deliver development strategy and prepare/assist with regulatory agency interactions
+ Develop or contribute to the regulatory documentation for the project(s), provide clinical leadership to other operational development activities pertaining to study start-up (e.g. pressure test, competitive intelligence, patient engagement, cluster feasibility, study risk assessment)
+ Provide appropriate medical input & clinical leadership for all activities related to study conduct such as responses 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
+ Responsible for the clinical part of regulatory documents, Common Technical Document for submission to regulatory bodies (FDA, EMA, PMDA) and answers to questions from health authorities.
+ Serve as the medical expert in the Clinical Study team, ensuring the medical relevance of the clinical data and able to act as mentor for other clinical team members, has the capacity to train them on the medical/scientific strategy by indication
**Scientific and Technical Expertise:**
+ Has and maintains deep scientific, technical, and clinical expertise in ophthalmology and retinal diseases
+ Understands and keeps updated with the pre-clinical, clinical pharmacology and data relevant to the molecule of interest
+ Critically reads and evaluates relevant medical literature with deep understanding of the data and status from competitive products
+ Maintains visibility within the therapeutic area to maintain credibility with internal and external stakeholders
**Key responsibilities:**
+ Designs the global clinical development strategy and generates the Clinical Development Plan (in close cooperation with other members of the team, particularly Regulatory Affairs and Health Economics); adjusts and updates the strategy according to the project progression and information available
+ Leads the clinical development including planned life cycle management (LCM)
+ Ongoing assessment of the product benefit-risk profile during development and LCM, in strong collaboration with pharmacovigilance and clinical operations team
+ Implements strategies to identify, monitor and resolve clinical program/trial issues.
+ Responsible for medical monitoring for a study or clinical program as well as reviewing and monitoring study data.
+ Provide appropriate medical input & support for all activities related to clinical studies such as medical training, feasibility, medical review of data, documents, medical information/communications for the study team and other stakeholders
+ Prepares/reviews key clinical documents such as: meeting requests and briefing packages for Regulatory agencies, extended synopsis/protocol for clinical trials, Investigator Brochure, Clinical Trial Authorization dossier (IMPD, IND), summary of clinical efficacy and clinical overview of the Common Technical Document (CTD).
+ Provides clinical input to Statistical Analysis Plans (SAP), Target Product Profile (TPP) and Risk Management Plan
+ Writes/reviews answers to clinical questions from Health Authorities and IRB/Ethics Committees and investigators
+ Reviews Key Results Memos, Clinical Study Reports as well as scientific publications and communications on the project
+ Lead the medical/clinical assessment of license-in opportunities, as needed
+ Manage other study physicians (CRDs) and clinical scientists in the same program, as needed
+ Author or co-author manuscripts and abstracts
+ Establishes and maintains appropriate collaborations with key opinion leaders or advisory boards
+ Serves as clinical team leader/representative at the global project team(s), regulatory agency meetings, Steering committees, benefit-risk assessment committee, and at the submission task force.
**About You**
**Basic Qualifications:**
+ Medical Doctor (MD) and ophthalmology residency training required, fellowship training highly preferred
+ More than 7 years of clinical trial and/or clinical development experience
+ Fluent in English (verbal and written)
**Preferred Qualifications:**
+ Board certified or eligible in Ophthalmology
+ Strong scientific and academic background with deep understanding of retina and eye diseases
+ Clinical trial or pharmaceutical experience in ophthalmology
+ Knowledge of drug development, ocular gene therapy, regulatory strategy
+ Good networking ability in cross-cultural environment
+ Strong interpersonal, communication, presentation, and negotiation skills across all levels of the organization
+ Performance oriented with ability to work along agreed timelines and a focus on strategy and execution
+ Outstanding communicator. Excellent problem-solving, conflict-resolution and decision-making skills
**Why Choose Us?**
+ Bring the miracles of science to life alongside a supportive, future-focused team.
+ Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
+ Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
+ 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' gender-neutral parental leave.
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.
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**Pursue** **_progress_** **, discover** **_extraordinary_**
Better is out there. Better medications, better outcomes, better science. But progress doesn't happen without people - people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let's be those people.
At Sanofi, we provide equal opportunities to all regardless of race, colour, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.
Watch our ALL IN video ( and check out our Diversity Equity and Inclusion actions at sanofi.com ( !
_US and Puerto Rico Residents Only_
Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally inclusive and diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; natural or protective hairstyles; 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.
_North America Applicants Only_
The salary range for this position is:
$225,000.00 - $325,000.00
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK ( .
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With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting or via our movie We are Sanofi ( an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live.
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Clinical Research Director, I and I, Pulmonology
Posted today
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Job Description
Job title : Clinical Research Director, I and I, Pulmonology
Location: Cambridge, MA
About the Job
Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate Progress.
The Clinical Research Director (CRD), Immunology & Inflammation (I&I) Therapeutic Area 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 for immunology, and to incorporate new methodologies and pro-actively progress study execution.
We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?
Main Responsibilities:
Create the clinical development strategy for one or more assets and document it in the clinical development plan in collaboration with the global project team and internal partners such as clinical operations, translational medicine, regulatory affairs, biostatistics, drug discovery, drug safety, marketing
Advance the CDP through internal management review
Leads a clinical subteam to design clinical studies and to create an abbreviated and full clinical study protocol
Oversee the execution of clinical studies in compliance with internal SOPs, GCP, ICH guidelines and other regulations
Review documents supporting clinical development such as Investigator’s brochure, regulatory documents for IND/CTA, clinical sections of integrated development plans, and submission dossiers for regulatory approval
Support drug registrations (contribution to submission dossiers label draft, regulatory response during the review process, Advisory Committee preparation)
Contribute to data review, interpretation and publication of clinical study results
Represent Clinical Development at Health Authorities and incorporating advise into development strategy
Maintain or establish interaction with external scientific and clinical communities and to incorporate pertinent advice and learnings into the internal program
Scientific and Technical Expertise:
This position requires a strong scientific and clinical foundation in internal medicine. Pulmonology is a plus. Advanced leadership skills and the ability to effectively collaborate with external partners, regulators, and diverse internal stakeholders and collaborators are essential prerequisites.
The candidate must
Be experienced in advancing assets from discovery into clinical development
Have experience in novel approaches in translational medicine
Have and maintain deep scientific, technical and clinical knowledge in immune driven disease and clinical immunology.
Demonstrated problem solving skills
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Understand and keep updated with the pre-clinical, clinical pharmacology and clinical data relevant to the molecule of interest and the respective therapeutic area
Be able to translate current understanding of disease pathogenesis into functional consequences and clinical outcome
Have an understanding of novel biomarker and precision medicine approaches, novel clinical trial designs, endpoints and statistical methods
About You
Basic Qualifications:
Medical Doctor. Should be board certified or equivalent in internal medicine / clinical immunology. Pulmonology is a plus.
Must have completed education and training at a medical school that meets the requirements of the Liaison Committee on Medical Education (LCME) or equivalent
Experience in relevant clinical, scientific and/or industry experience within the field of immune driven diseases. Pulmonology is a plus.
Strong scientific and academic background within clinical research, pharmaceutical experience or experimental medicine experience internal medicine, clinical immunology. Pulmonology is a plus.
Knowledge of drug development preferred
Strong interpersonal, communication, presentation, negotiation and networking skills in a cross-cultural global environment
Performance oriented with ability to work along agreed timelines
Why Choose Us?
Bring the miracles of science to life alongside a supportive, future-focused team.
Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.
Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
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’ gender-neutral parental leave.
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.
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