9 Clinical Development Director jobs in Boca Raton

• Design and execute clinical trials for neuropsychiatric products, ensuring compliance with regulatory requirements.
• Collaborate with cross-functional teams to develop study protocols and manage trial progress.

• Provide medical oversight during clinical trials to ensure participant safety and data integrity.
• Review and interpret safety signals, adverse events, and efficacy data in collaboration with pharmacovigilance teams.

• Develop and refine TPPs by outlining desired product characteristics such as indications, target population, dosing regimen, safety profile, and clinical efficacy.
• Align TPPs with regulatory requirements and commercial goals to guide product development strategies.

• Conduct comprehensive evaluations of potential new products or acquisitions by assessing their clinical viability, market potential, probability of clinical/regulatory success etc
• Provide expert recommendations based on scientific and medical analysis.

• Ensure adherence to regulatory standards (e.g., FDA) and quality management systems.
• Addressing clinical/medical queries from health authorities.

• 5 to 10 years in neurology or psychiatry, with a focus on clinical trials and patient care.
• MD or equivalent degree with training in neurology or psychiatry.
• Proven leadership abilities, strong knowledge of regulatory frameworks, GCP guidelines, and quality management systems.
• Medical practice experience in neuropsychiatry.

The Neuropsychiatry Clinical Development Medical Lead will oversee the clinical and medical aspects of new respiratory medicines, including new drug or 505(b)(2) applications. This role involves strategic leadership in clinical trials, clinical sciences, medical monitoring, target product profile (TPP) development, due diligence projects, and regulatory compliance. The ideal candidate will have training in neurology or psychiatry and experience working in neurology and psychiatric disease trials.

Essential Duties and Responsibilities

Clinical Development:

• Design and execute clinical trials for neuropsychiatric products, ensuring compliance with regulatory requirements.
• Collaborate with cross-functional teams to develop study protocols and manage trial progress.

Medical Monitoring:

• Provide medical oversight during clinical trials to ensure participant safety and data integrity.
• Review and interpret safety signals, adverse events, and efficacy data in collaboration with pharmacovigilance teams.

Target Product Profile (TPP) Contributions:

• Develop and refine TPPs by outlining desired product characteristics such as indications, target population, dosing regimen, safety profile, and clinical efficacy.
• Align TPPs with regulatory requirements and commercial goals to guide product development strategies.

Due Diligence Projects:

• Conduct comprehensive evaluations of potential new products or acquisitions by assessing their clinical viability, market potential, probability of clinical/regulatory success etc
• Provide expert recommendations based on scientific and medical analysis.

Regulatory Compliance:

• Ensure adherence to regulatory standards (e.g., FDA) and quality management systems.
• Addressing clinical/medical queries from health authorities.

Education and Experience

• 5 to 10 years in neurology or psychiatry, with a focus on clinical trials and patient care.
• MD or equivalent degree with training in neurology or psychiatry.
• Proven leadership abilities, strong knowledge of regulatory frameworks, GCP guidelines, and quality management systems.
• Medical practice experience in neuropsychiatry.

Lupin is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, gender, religion, age, disability, veterans status, or any other classification as required by applicable law.

Physical Requirements

The physical requirements of the position generally include: standing, walking, sitting, using hands and fingers, reaching with hands and arms, talking and hearing. In some circumstances, bending, kneeling, crouching, stooping, and crawling may apply. This position may require lifting up to 15 pounds occasionally. Generally work is performed in an office environment.

Search Firm Representatives Please Read Carefully

LupinUSA, and its Affiliates does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firmsfor any current openingsat our company without a valid written search agreement in placewill be deemed the sole property ofLupin.No fee will be paid in the event a candidate is hiredbyLupinas 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

Clinical Development:Design and execute clinical trials for respiratory products, ensuring compliance with regulatory requirements. Collaborate with cross-functional teams to develop study protocols, analyze trial data, and manage trial progress. Med Clinical, Medical, Director, Respiratory, Associate, Development, Healthcare

The Neuropsychiatry Clinical Development Medical Lead will oversee the clinical and medical aspects of new respiratory medicines, including new drug or 505(b)(2) applications. This role involves strategic leadership in clinical trials, clinical sciences, medical monitoring, target product profile (TPP) development, due diligence projects, and regulatory compliance. The ideal candidate will have training in neurology or psychiatry and experience working in neurology and psychiatric disease trials.

Essential Duties and Responsibilities

Clinical Development:

• Design and execute clinical trials for neuropsychiatric products, ensuring compliance with regulatory requirements.
• Collaborate with cross-functional teams to develop study protocols and manage trial progress.

Medical Monitoring:

• Provide medical oversight during clinical trials to ensure participant safety and data integrity.
• Review and interpret safety signals, adverse events, and efficacy data in collaboration with pharmacovigilance teams.

Target Product Profile (TPP) Contributions:

• Develop and refine TPPs by outlining desired product characteristics such as indications, target population, dosing regimen, safety profile, and clinical efficacy.
• Align TPPs with regulatory requirements and commercial goals to guide product development strategies.

Due Diligence Projects:

• Conduct comprehensive evaluations of potential new products or acquisitions by assessing their clinical viability, market potential, probability of clinical/regulatory success etc
• Provide expert recommendations based on scientific and medical analysis.

Regulatory Compliance:

• Ensure adherence to regulatory standards (e.g., FDA) and quality management systems.
• Addressing clinical/medical queries from health authorities.

Education and Experience

• 5 to 10 years in neurology or psychiatry, with a focus on clinical trials and patient care.
• MD or equivalent degree with training in neurology or psychiatry.
• Proven leadership abilities, strong knowledge of regulatory frameworks, GCP guidelines, and quality management systems.
• Medical practice experience in neuropsychiatry.

Lupin is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, national origin, gender, religion, age, disability, veterans status, or any other classification as required by applicable law.

Physical Requirements

The physical requirements of the position generally include: standing, walking, sitting, using hands and fingers, reaching with hands and arms, talking and hearing. In some circumstances, bending, kneeling, crouching, stooping, and crawling may apply. This position may require lifting up to 15 pounds occasionally. Generally work is performed in an office environment.

Search Firm Representatives Please Read Carefully

LupinUSA, and its Affiliates does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firmsfor any current openingsat our company without a valid written search agreement in placewill be deemed the sole property ofLupin.No fee will be paid in the event a candidate is hiredbyLupinas 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

About Us: Each of CenExel's research sites specialize in Phase I to Phase IV clinical trials. Our Centers of Excellence comprise some of the most well respected and long-standing research facilities in the country. Specialty areas of research across our sites include Psychiatry, Acute Post Op Pain, Asian Bridging, Dermatology, GI, and Neurology. Each of our Centers of Excellence has tremendous experience and expertise in complex early phase trials, and all our sites have in-patient capability. We focus on quality people, teamwork, and highly experienced clinical research managers with a history of success.Along with an exceptional work environment that promotes teamwork, positive leadership, and optimal work-life balance, CenExel Clinical Research also provides highly competitive compensation and a generous benefits package to full time employees after 30 days of employment including Health Insurance, Dental, Vision, LTD, STD, Life Ins, and 401k.Job Summary: Independently responsible for coordinating all aspects of multiple and/or complex clinical trials with the strictest adherence to ICH (International Conference on Harmonization), GCP (Good Clinical Practices), protocol, and company guidelines, regulations, and policies.Essential Responsibilities and Duties:Coordinates all aspects of patient involvement for complex and/or multiple studies from study initiation until study completion.Organizes research information for clinical trials.Observes subjects and assists with data analysis and reporting.Oversees study protocol scheduling and collection of data.Identifies, reviews, and reports adverse events, protocol deviations, and other unanticipated problems appropriately.Manages, monitors, and reports research data to maintain quality and compliance.Performs administrative and regulatory duties related to the study as appropriate.Participates in other protocol development activities.Works collaboratively with internal departments, sponsors and investigators to ensure protocols are understood and assists in training staff members.Ensures site receives accurate information and supplies from sponsors (i.e.: source, protocol, scales, supplies, approvals, contacts, etc.)Educates potential participants and caregivers on protocol specific details and expectations.Performs safety and efficacy assessments per protocol (vital signs, EKGs, blood draws and other assessments as assigned).Assists senior management with site qualification visits by knowledge of staff credentials, equipment, calibrations, and enrollment capabilities.Assesses and delegates daily tasks to research staff, ensuring goals of accuracy and timeliness.Trains, mentors, and/or manages Research Assistants and lower level Clinical Research Coordinators.Assumes other duties and responsibilities as assigned. The above responsibilities are a general description of the level and nature of the work assigned to this classification and are not to be considered as all inclusive.Education/Experience/Skills:Must have proper experience and demonstrate mastery of Clinical Research Coordinator II position.Bachelor's degree, preferred.CCRC certification preferred.5 years of experience in the medical field or Masters Degree, preferred.Knowledge and understanding of Federal regulations protecting human subjects in research and that govern the conduct of clinical trials.Strong leadership and mentorship skills.Developing and maintaining effective working relationships at all levels of the organization, along with those at the sponsor and vendor level.Crisis management and problem solving skills; ability to react calmly and effectively in emergent situations.Works independently as well as functioning as part of a team.Must be able to effectively communicate verbally and in writing in both English and Spanish.Working Conditions Indoor, Office environment.Shift work, depending on location.Essential physical requirements include sitting, typing, standing, and walking.Lightly active position, occasional lifting of up to 20 pounds.Reporting to work, as scheduled, is essential.Overnight travel may be required for training and/or investigative meetings.CenExel Clinical Research is an Equal Opportunity Employer. All applicants will be considered for employment without regards to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or status. Equal Opportunity Employer This employer is required to notify all applicants of their rights pursuant to federal employment laws. For further information, please review the Know Your Rights notice from the Department of Labor.

Job DetailsJob LocationHollywood Dermatology - Hollywood - Hollywood, FLTravel PercentageNegligibleJob ShiftDayJob CategoryResearchDescriptionClinical Research CoordinatorCompnay Name: Skin Center ResearchParent Company: DermCare Management LLCWork Location: Hollywood Blvd, Hollywood FL ( Near Presidential Circle)We are looking for candidates with medical backgrounds and excellent interpersonal skills for the position of clinical research coordinator. Clinical research coordinators are responsible for conducting clinical research trials by adhering to Good Clinical Practice (GCP), International Air Transportation (IATA) and FDA regulations. The candidate will be performing required visit procedures, administering questionnaires and subject material, adhering to regulatory trial standards, and participating in subject recruitment efforts, among other duties.Clinical research coordinators need to engage with the research investigators, pharmaceutical companies (sponsors) and contract research organizations (CROs) as well as the research subjects requiring excellent interpersonal and communicative skills.Clinical Research Coordinator Responsibilities:Overseeing the smooth running of clinical trials.Performing clinic visits as per the protocol, GCP and FDA Completing procedures such as phlebotomy, EKGs Vitals, assessmentsCollecting and entering data obtained for the trial Informing participants about study objectives.Administering questionnaires.Monitoring research participants to ensure adherence to study rules.Adhering to research regulatory standards.Adhering to ethical standards.Maintaining detailed records of studies as per FDA guideline and regulatory documentationManaging investigational medication including receiving, dispensing, storing and performing accountabilityLiaising with laboratories process, ship and ensure investigators review reportsParticipating in subject recruitment efforts.Ensuring that the necessary supplies and equipment for a study are in stock and in working order.Engaging with subjects and understanding their concerns and managing the visit flow as indicating in the protocol.QualificationsAssociate degree in nursing or related field.2+ years in healthcareGCP, IATA trainingAttention to detail.Exceptional interpersonal skills.Good computer and technical skills Outstanding written and verbal communication.Excellent organizational skills.Willingness to continually self-educate.CCRC certification a plus Bi-lingual in Spanish is a plus DermCare Management, LLC is proud to be an Equal Opportunity Employer. We value diversity and are committed to fostering an inclusive environment for all employees. We prohibit discrimination based on race, color, religion, gender, national origin, age, disability, veteran status, marital status, or any other protected characteristic.

• Responsible for the performance of the research study under the medical supervision of the Principal Investigator and the research director.
• The research coordinator is responsible for the overall successful implementation and ongoing site management of the research studies.
• May be responsible for providing coverage in clinics when research staff are out of the office; for precepting new research staff in clinics; for assisting with research projects assigned by the Senior Clinical Research Coordinator III.

• Candidates must have a valid RN license, in state of employment,
• a minimum of one-year oncology or clinical research experience;
• or a minimum of five years of combined clinical oncology and clinical research experience.
• Candidates must have effective communication skills,
• be organized,
• detail oriented,
• strong patient advocates.
• Candidates must be available to travel to investigators meetings.
• Valid Driver's License, in state of residency, for travel to clinics.
• Must comply with the Company's Driver Safety Operations and Motor Vehicle Records Check Pol