Clinical Drug Investigator Stellenangebote

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Stellenangebote Clinical Drug Investigator Jobs bei Jobleads

Job vom 11.10.2024

Lead Medical Writer (Reporting to Vice President Regulatory Affairs)

• Wuppertal, Nordrhein- Westfalen Führungs-/ Leitungspositionen

MEHR

Your mission As a Lead Medical Writer, you will plan, author, and organize the review process of documents pertaining to clinical studies and regulatory interactions, including (but not limited to) critical sections of marketing applications, protocols, clinical study reports, briefing documents, [...] external publishing team. Is a key strategic participant in functional and cross- functional teams. Actively contributes to best practices and continuous improvement of initiatives and projects. Maintains up- to- date knowledge of key regulatory, scientific, and medical topics relevant to drug development and therapeutic areas. Your profile Bachelor s degree or equivalent. Advanced degree in life sciences or related field, or equivalent experience preferred. Working or academic knowledge in anti- infectives/ antiviral therapeutics is preferable. Proven track record in writing clinical regulatory documents including, but not limited to: protocols, clinical study reports, NDA/ MAA CTD submission documents, investigator brochures, briefing documents, and responses to regulatory authority questions. Demonstrated ability to produce clear, high- quality scientific writing in the [...]
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Job vom 08.10.2024 Field Medical Director • Boudry, Neuenburg Führungs-/ Leitungspositionen

MEHR

[...] disease strategy. The individual will lead the execution and implementation of the pan- CART medical affairs plan, delivering planned tactics and supporting global affiliates for Cell Therapy launches. Responsibilities include the development and approval of medical and educational materials, support clinical studies as needed as well as assisting with global and regional pan- CART strategy. Collaboration with WW Commercial, WW Clinical, WW Quality, WW Manufacturing, and Market Access colleagues is essential to establish and recommend priorities within the WW CTF strategy. The role also supports the design and planning of medical data generation, including Investigator Sponsored Research and medical affairs sponsored trials. Additionally, the individual will collaborate with senior members of the pan- CART MA [...] including a medical scientific degree (MS, PhD, MD) in medicine, molecular biology, genomics, cancer biology, or another relevant life sciences area, combined with over 2 years of experience in hematology/ oncology within academia or industry. Experience and knowledge of the drug development and/ or commercialization process are crucial. The ideal candidate will have a proven track record of delivering value in [...]

Job vom 08.10.2024

Field Medical Director

• Boudry, Neuenburg Führungs-/ Leitungspositionen

MEHR

Job vom 30.09.2024 Medical Science Liaison Oncology • München, Bayern

MEHR

The Medical Science Liaison (MSL) is engaged in scientific field work and its main goal is to build partnerships and communicate with external clinical and non- clinical stakeholders (physicians, pharmacists, hospital managers, board members of scientific societies and other stakeholders) on an equal footing [...] products and therapeutic areas and thus support patient care. Speaker training and support for healthcare professionals to maintain knowledge within the medical community about new therapies developed and marketed by our client. Identify and pursue potential research opportunities consistent with drug development objectives through the promotion of clinical research (e. g. non- interventional studies, registries, epidemiological projects, preclinical or translational research) [...] with the Medical TA and the relevant business unit managers. Collaborate with external/ internal research colleagues and medical advisors to support clinical sites and provide feasibility and site recommendations by guidelines, internal policies and regulations. At the request of the investigator: Mediation between potential researchers and the company in the submission of IST studies (Investigator Sponsored Studies) . Managing the contracting [...]

Job vom 16.08.2024

(Sr) Medical Director in Neurology/ United Kingdom or Germany

Führungs-/ Leitungspositionen

MEHR

Our Client is an international drug development organization, one of the top companies globally in this area. As a result of their growing business, they are looking for Medical Director who will focus on clinical development in the area of Neurology in phases II- III of clinical trials. In this position you will: Provide internal [...] to projects Train project teams (both internal and external) Requirements: Medical Doctor, ideally with a board certification in Neurology and proven clinical experience in this area Experience in clinical development, preferably from CRO/ pharma/ biotech company or experience as an investigator in clinical trials Good leadership and project management skills Fluency in English, very good interpersonal and communication skills This role [...]
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Job vom 19.06.2024 Neurology Medical Director (Associate/ Senior) Führungs-/ Leitungspositionen

MEHR

[...] and health. We push science forward by conducting groundbreaking research, developing ground- breaking treatments, and supplying our teams with the tools necessary to help each member of the team realize their professional ambitions. Our work encompasses laboratory, digital, and decentralized clinical trial services, with clinical trials carried out in more than 100 countries and the continuous development of innovative frameworks for [...] research through our PPD clinical research portfolio. People and communities that rely on improved health outcomes today and in the future will benefit from your commitment to providing quality and accuracy. Discover impactful work: Throughout all stages of the clinical drug development process, this role offers tactical oversight and strategic leadership for the clinical and medical components. In compliance with relevant [...] make sure that reporting is completed on schedule. When necessary, work together with the independent safety committee and the study executive. Participate in trial teams to represent clinical research. Contributes to, reviews and approves study protocols, protocol amendments, study manuals, Investigator Brochures (IBs) , Clinical Study Reports (CSRs) , Informed Consent Forms (ICFs) , Case Report Forms (CRFs) and other clinical [...]
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Stellenangebote Clinical Drug Investigator Jobs bei Freelance.de

Job vom 31.10.2024

Für Freelancer- Medical Monitor- Cardiovascular/ Oncology

• München Freiberuflich

MEHR

[...] insights for risk mitigation strategies. Create and update Medical Monitoring Plans. Provide medical expertise to support study teams, investigators, and sites. Offer medical input on adverse event management, including reviewing cumulative ADR/ SAE listings and other emerging safety data. Review clinical data and critical study parameters. Assist the Senior Project Leader with daily logistics of assigned study tasks, including administrative duties [...] Affiliates, and other functional departments at DS. Support Affiliates during the site selection process. Partner with the Senior Project Leader in budget control and forecasting. Engage in study- related interactions with healthcare professionals in Steering Committees, Data Safety Boards, and Investigator Meetings. Requirements You hold a graduate degree medical doctor (MD) or pharmacist with at least 6 years relevant clinical and [...] of Clinical Research Principles, ICH- GCP, EU regulations governing clinical trials, standard regulatory and clinical practices and current regulatory issues related to clinical research; familiar with local regulations for non- interventional studies within EU) Knowledge of pharmaceutical business and international drug development Pro- active and self- motivated personality Excellent presentation communication skills- combined with a strong stakeholder focus Fluent written and [...]
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Weitere Stellenangebote Clinical Drug Investigator bei Jobleads

Job gestern gefunden Senior Medical Director Oncology Clinical Development- Solid Tumor • Schaffhausen Führungs-/ Leitungspositionen

MEHR

[...] information about Abb Vie, please visit us at www. abbvie. com . Follow abbvie on Twitter , Facebook , Instagram , You Tube and Linked In . Job Description Leads and demonstrates ownership of the design and implementation of multiple clinical development programs (or one large, complex program) in support of the overall product development plan, based on strong medical and [...] timelines for key deliverables. Responsible for assessment and reporting of serious adverse events per corporate policy and regulations for those protocols on which assigned. Primary responsibility for and ownership of design, analysis, interpretation, and reporting of scientific content of protocols, Investigator Brochures, Clinical Study reports, regulatory submissions and responses, and other program documents. May oversee the work of Medical and/ or [...] professional information and technology through conferences, medical literature, and other available training, to augment expertise in the therapeutic area. May represent Abb Vie at key external meetings. Responsible for understanding the regulatory requirements related to the clinical studies and global drug development and accountable for complying with those requirements. Serves as a clinical representative for key regulatory discussions. Ensures adherence to [...]

Job vor 3 Tagen gefunden

Senior Auditor, Audits and Inspections Program

• Berlin

MEHR

[...] path to a cure for the world s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence. We are Worldwide Clinical Trials, and we are a global team of over 3, 500+ experts, bright thinkers, dreamers and doers and, together, we [...] adheres to Worldwide s Quality Management System (QMS) Serves as a positive ambassador of the QA organization with internal and external customers Develops and executes to personal and QA goals and objectives Performs QA audits for Vendors, Internal Process, Clinical Investigator, Document (Clinical Study reports, Trial Master File, Database) and other audits, as assigned Ensures quality deliverables, on time, and in [...] Audits, Document Audits, etc. ) Previous experience in trending and analysis methodologies Your experience M. S. in a scientific or allied health filed and 5+ years of relevant GCP, GcLP, GLP, GVP, and/ or GPP experience Excellent understanding of the Drug Development Process Minimum 3 years of Quality Assurance auditing experience IT literate, experienced with Microsoft based applications, including proficiency in [...]
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Job vor 6 Tagen gefunden VP Clinical Development

MEHR

Job Description Job Title: VP Clinical Development- Oncology Tasks Responsibilities In this role, you represent Medicine at the International Multidisciplinary Evidence Teams and take clinical development responsibility for the projects assigned. For example: definition of Target Product Profiles, Asset Evidence Plan, Pediatric Investigational Plan, core Clinical Trial Protocols, input to Project Analysis and Data Management Plan, Investigator Brochure, medical input to the Company Core Data sheet, Annual Safety Report/ IND Safety Reports, preparation for the Milestones Start [...] Core Clinical Trial Protocols and Pediatric Development Plans together with your cross- functional project teams. Mentor a team of Clinical Program Leads. Provide input to Project Analysis Data Management Plans, Company Core Data Sheet, Annual Safety Report/ IND (Investigational New Drug) Safety Reports. Provide medical leadership in regulatory meetings and support submission strategy, regulatory dossiers, and safety issues. Maintain an external [...]

Job vor 6 Tagen gefunden Senior Auditor, Audits and Inspections Program

MEHR

[...] path to a cure for the world s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence. We are Worldwide Clinical Trials, and we are a global team of over 3, 500+ experts, bright thinkers, dreamers and doers and, together, we [...] adheres to Worldwide s Quality Management System (QMS) Serves as a positive ambassador of the QA organization with internal and external customers Develops and executes to personal and QA goals and objectives Performs QA audits for Vendors, Internal Process, Clinical Investigator, Document (Clinical Study reports, Trial Master File, Database) and other audits, as assigned Ensures quality deliverables, on time, and in [...] Audits, Document Audits, etc. ) Previous experience in trending and analysis methodologies Your experience M. S. in a scientific or allied health field and 5+ years of relevant GCP, GcLP, GLP, GVP, and/ or GPP experience Excellent understanding of the Drug Development Process Minimum 3 years of Quality Assurance auditing experience IT literate, experienced with Microsoft based applications, including proficiency in [...]

Job vor 6 Tagen gefunden Executive Director Clinical Development Führungs-/ Leitungspositionen

MEHR

Job Description Job Title: Executive Director Clinical Development- Oncology Tasks Responsibilities In this role, you represent Medicine at the International Multidisciplinary Evidence Teams and take clinical development responsibility for the projects assigned, including definition of Target Product Profiles, Asset Evidence Plan, Pediatric Investigational Plan, core Clinical Trial Protocols, input to Project Analysis and Data Management Plan, Investigator Brochure, medical input to the Company Core Data sheet, Annual Safety Report/ IND Safety Reports, preparation for the Milestones Start [...] Core Clinical Trial Protocols, and Pediatric Development Plans together with your cross- functional project teams. Mentor a team of Clinical Program Leads. Provide input to Project Analysis Data Management Plans, Company Core Data Sheet, Annual Safety Report/ IND (Investigational New Drug) Safety Reports. Provide medical leadership in regulatory meetings and support submission strategy, regulatory dossiers, and safety issues. Maintain an external [...]

Job vor 8 Tagen gefunden

Early Clinical Lead (all genders) Job Details Bayer AG

• Berlin Führungs-/ Leitungspositionen

MEHR

[...] impossible . There are so many reasons to join us. If you re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there s only one choice. Early Clinical Lead (all genders) The incumbent for this position may be based in the United States (US) , Germany or Switzerland. [...] laws. As such, applicants should expect to experience differences in the application process which are unique from a single country posting. YOUR TASKS AND RESPONSIBILITIES As ECL, you lead the early clinical team responsible for the early clinical development of drug candidates (until Proof of Concept/ PoC) . Accountable and responsible for coordinating the design, execution and delivery of the early [...] understanding of the targeted indication and the medical need, the medical/ clinical interpretation of study data, and additional relevant medical and scientific information. Provide input, final review as well as the clinical approval for clinical documents: e. g. study protocols, investigator brochures (IBs) , study reports, statistical analysis plans, publications, clinical sections of IND/ CTA submissions. Provides medical/ clinical assessment of [...]

Job vor 9 Tagen gefunden Medical Science Liaison (MSL) , Germany (Temporary Worker Position) • Leipzig, Sachsen

MEHR

[...] of position: Senior Manager Position type: field- based Reporting Line: The position reports to the Country Medical Affairs Director How will your role help us transform hope into reality? The Medical Science Liaison (MSL) is a field- based scientific and clinical expert who strategically supports the medical objectives of Blueprint Medicines development programs. The MSL is responsible for identifying, developing, and [...] and insights from interactions and discussions with HCPs. Accurately profile country and define local dynamics related to patient diagnosis and referral for treatment Deliver medical/ scientific presentations to internal external stakeholders Assist with company- sponsored clinical trials and facilitation of investigator- initiated trials (ISTs) Lead planning and execution of regional advisory boards Collaborate with cross- functional partners on internal projects and [...] seek to alleviate human suffering by solving important medical problems in two core focus areas: allergy/ inflammation and oncology/ hematology. Our approach begins by targeting the root causes of disease, using deep scientific knowledge in our core focus areas and drug discovery expertise across multiple therapeutic modalities. We have a proven track record of success with two approved medicines, including bringing [...]

Job vor 10 Tagen gefunden

Site Contracting Team Lead (m/f/d)

Führungs-/ Leitungspositionen

MEHR

[...] ability to impact the health and lives of millions of people. Right now, we are seeking highly qualified candidates to fill the position: About the role: The Site Contracting Team Lead is responsible for leading a team of 8- 12 Investigator Contracts Leads to plan and achieve contract execution targets while raising and managing risks to those targets. This role also [...] within the scope of oversight. Responsible for relationship management with CROs and FSP performing site contracting activities. About You: Several years of experience with a 4- year degree (BA/ BS or equivalent) . Expert in one or more areas of clinical site contracting. Knowledge of clinical development process. Ability to oversee third- party vendor deliverables to agreed quality and timelines. Experience leading cross- functional teams. Experience in interaction with senior leaders within the organization. Experience with clinical study budgets and contracting negotiation principles, practices, processes, and activities. Balance of general business, compliance, finance, legal, and drug development experience. Clear communications and presentation skills. Ability to problem solve unique issues and prioritize. Demonstrated ability to lead and [...]

Job vor 12 Tagen gefunden Clinical Pharmacology Director • Genf Führungs-/ Leitungspositionen

MEHR

[...] that seek to improve the quality of life for people living with cancer and rare diseases. You will be supporting the international roll- out of our approved prostate cancer imaging agent and helping us to advance our portfolio of late clinical- stage products that address significant unmet need in oncology and rare diseases. See Yourself at Telix We are seeking an [...] teams including clinical development, regulatory, medical affairs, and research innovation to bring groundbreaking treatments to market. Key Accountabilities: Design and implement clinical pharmacology strategies to support the development of radiopharmaceuticals, including dose selection, pharmacokinetics (PK) , pharmacodynamics (PD) , and drug- drug interaction studies. Provide scientific and clinical leadership in the integration of radiopharmacology and pharmacokinetic modeling to advance therapeutic and diagnostic candidates. Collaborate with internal stakeholders to align clinical pharmacology efforts with broader drug development objectives. Lead the design of early- phase clinical pharmacology studies. Collaborate on the development of clinical study protocols, investigator brochures, and regulatory submissions with cross- functional teams. Ensure clinical pharmacology studies comply with regulatory guidelines and are scientifically rigorous. [...]

Job vor 12 Tagen gefunden

Medical Director- Oncology Clinical Development- B7- H3

Führungs-/ Leitungspositionen

MEHR

[...] Upper Providence, Switzerland- Zug, UK- Hertfordshire- Stevenage, UK London New Oxford Street, USA- Massachusetts- Waltham, Warsaw Rzymowskiego 53 Posted Date: Oct 30 2024 Are you a pharma physician or academic clinician keen to be part of GSKs growing oncology antibody drug conjugate (ADC) portfolio for the treatment of solid tumors in GI, GU and beyond? If so, this position is a must to consider. THE POSITION: The Medical Director Oncology Clinical Development will report to the Executive Medical Director, Clinical Development Lead (CDL) , Oncology Clinical Development. The Medical Director will [...] hematology; hematology/ oncology; general surgery or internal medicine. Experience in the pharmaceutical/ biotechnology industry; clinical academic medicine or clinical medical practice settings in the field of oncology. Oncology clinical drug development process experience in the conduct/ participation of clinical trials (investigator initiated, company sponsored or cooperative group trials) and their subsequent publications. Regulatory experience to support registration and GCP principle. Preferred [...]

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