الصفحة الرئيسية United States Director of Clinical Development
الصفحة الرئيسية United States Director of Clinical Development
Director of Clinical Development
تفاصيل الوظيفة
CSL Behring is a global biotechnology leader, guided by a promise to save and improve lives. Millions of people around the world are living with rare and serious medical conditions. CSL Behring is committed to delivering medicines that improve their lives. With operations in 35+ nations and ~ 30,000 employees worldwide, CSL is inspired to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment. CSL is the parent company of CSL Behring, CSL Plasma, CSL Seqirus and CSL Vifor. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. Could you be our next Clinical Science Director? This position is located in our King of Prussia PA, Marburg Germany or Bern Switzerland office. It is a Hybrid role. You will report to the Global Clinical Lead.
The Opportunity
You will use your MD degree and Clinical Development experience to take global responsibility for medical oversight of selected pipeline and products within the assigned therapeutic area(s). You will be responsible for.medical standards and processes according to expectations of manufacturers by all partners including regulators, governmental agencies, payors, physicians, patients and the general public.The Role
- You will provide medical expertise for clinical study oversight and safety concerns within the assigned therapeutic area as the Medical monitor. Present results to Safety Monitoring Committee and other internal and external meetings. Provide medical and scientific input for the safe, efficient, and execution of assigned clinical programs.
- Review the data generated during the execution of a study to gather a medical understanding of the safety and efficacy results and the impact of the data on ongoing R&D strategies and provides support in defining the development strategy.
- Responsible or participate in the ongoing data reviews. Contribute to the drafting/review of clinical study protocol/reports and other documents. Provide medical insight to the draft or draft responses to regulatory agencies and IRBs/ECs or other regulatory documents.
- Set technical medical strategies for global projects and therapeutic areas, consistent with functional expectations.
- Identify potential challenges, risks and roadblocks associated with the global medical strategy and work as a leader in developing solutions to address these, working and inter-functionally with other departments.
Your experience
- Minimum of MD (Medical Doctor degree) or international equivalent plus accredited residency.
- 2+ years as a physician in patient care.
- 3+ years pharmaceutical / biotechnology industry experience, with 1year including accountability for medical oversight/evaluation or clinical development
- Academic- And -Industry experience in Solid Organ Transplantation would be useful.
- Experience addressing and managing complex medical issues in the pre-approval and post-approval environment.
- Medical, Dental Vision
- 401K
- Paid time Off
Our Benefits
CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals. Please take the time to review our benefits site to see what’s available to you as a CSL employee.About CSL Behring
CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring .We want CSL to reflect the world around us
As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.Do work that matters at CSL Behring!
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Development', 'vacancies' => null, 'job_type_id' => null, 'description' => null, 'pay_status' => 'Free', 'external_job_description' => '<p> CSL Behring is a global biotechnology leader, guided by a promise to save and improve lives. Millions of people around the world are living with rare and serious medical conditions. CSL Behring is committed to delivering medicines that improve their lives. </p><p></p><p> With operations in 35+ nations and ~ 30,000 employees worldwide, CSL is inspired to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment. CSL is the parent company of CSL Behring, CSL Plasma, CSL Seqirus and CSL Vifor. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. </p><p></p><p> Could you be our next Clinical Science Director? This position is located in our King of Prussia PA, Marburg Germany or Bern Switzerland office. It is a Hybrid role. 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Provide medical and scientific input for the safe, efficient, and execution of assigned clinical programs. </p></li><li><p> Review the data generated during the execution of a study to gather a medical understanding of the safety and efficacy results and the impact of the data on ongoing R&D strategies and provides support in defining the development strategy. </p></li><li><p> Responsible or participate in the ongoing data reviews. Contribute to the drafting/review of clinical study protocol/reports and other documents. 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We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals. </p><p></p><p> Please take the time to review our benefits site to see what’s available to you as a CSL employee. </p><h2><b> About CSL Behring </b></h2><p> CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring . </p><p></p><h2><b> We want CSL to reflect the world around us </b></h2><p> As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. 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To achieve TQUK Endorsed Diploma of Level 7 Business Development and Administration learner must have to achieve 16 Modules with 160 Credits.</p><p> Modules Outline</p><p> Module1: Human Resource Management</p><p> Describe the implications of different aspects of HRM on their daily responsibilities</p><p> Define human resources terms and subject matter</p><p> Recruit, interview, and retain employees more effectively</p><p> Follow up with new employees in a structured manner</p><p> Be an advocate for your employees’ health and safety</p><p> Provide accurate, actionable feedback to employees</p><p> Module2: Communication Strategies</p><p> Understand what communication is</p><p> Identify ways that communication can happen</p><p> Identify barriers to communication and how to overcome them</p><p> Develop their non-verbal and par verbal communication skills</p><p> Use the STAR method to speak on the spot</p><p> Listen actively and effectively</p><p> Module3: Conflict Resolution</p><p> Understand what conflict and conflict resolution mean</p><p> Understand all six phases of the conflict resolution process</p><p> Understand the five main styles of conflict resolution</p><p> Be able to adapt the process for all types of conflicts</p><p> Be able to break out parts of the process and use those tools to prevent conflict</p><p> Module4: Change Management</p><p> List the steps necessary for preparing a change strategy and building support for the change</p><p> Describe the WIFM – the individual motivators for change</p><p> Use needed components to develop a change management and communications plans, and to list implementation strategies</p><p> Employ strategies for gathering data, addressing concerns and issues, evaluating options and adapting a change direction</p><p> Utilize methods for leading change project status meetings, celebrating a successful change implementation, and sharing the results and benefits</p><p> Module5: Business Acumen</p><p> Know how to see the big picture</p><p> Develop a risk management strategy</p><p> Know how to practice financial literacy</p><p> Develop critical thinking</p><p> Practice management acumen</p><p> Find key financial levers</p><p> Module6: Business Ethics</p><p> Define and understand ethics.</p><p> Understand the benefits of ethics.</p><p> Create strategies to implement ethics at work.</p><p> Recognize social and business responsibility.</p><p> Identify ethical and unethical behavior.</p><p> Learn how to make ethical decisions and lead with integrity.</p><p> Module7: Business Etiquette</p><p> Define etiquette and provide an example of how etiquette can be of value to a company or organization.</p><p> Understand the guidelines on how to make effective introductions.</p><p> Identify the 3 C’s of a good impression.</p><p> Identify at least one way to minimize nervousness while in social situations.</p><p> Understand how to use a business card effectively.</p><p> Identify and practice at least one way to remember names.</p><p> Identify the 3 steps in giving a handshake.</p><p> Module8: Business Development and Succession Planning</p><p> Define business Development and Succession planning and its role in your company.</p><p> Lay the groundwork to develop a Development and Succession plan.</p><p> The importance of mentorship.</p><p> Define and use a SWOT analysis to set goals.</p><p> Create a plan, assign roles, and execute the plan.</p><p> Module9: Facilitation Skills</p><p> Define facilitation and identify its purpose and benefits.</p><p> Clarify the role and focus of a facilitator.</p><p> Differentiate between process and content in the context of a group discussion.</p><p> Provide tips in choosing and preparing for facilitation.</p><p> Module 10: Organisational Skills</p><p> Examine current habits and routines that are not organized</p><p> Learn to prioritize your time schedule and daily tasks</p><p> Determine ways of storing information and supplies</p><p> Module 11: Negotiation Skills</p><p> Understand the basic types of negotiations, the phases of negotiations, and the skills needed for successful negotiating</p><p> Understand and apply basic negotiating concepts: WATNA, BATNA, WAP, and ZOPA</p><p> Lay the groundwork for negotiation</p><p> Identify what information to share and what to keep to yourself</p><p> Understand basic bargaining techniques</p><p> Apply strategies for identifying mutual gain</p><p> Module 12: Crisis Management</p><p> Understand the myths behind workplace violence</p><p> Define escalation and identify examples</p><p> Learn concerning behaviors</p><p> Know what a trigger is and how that can escalate</p><p> Understand the proper response to an event</p><p> Module 13: Administrative Support Skills</p><p> Getting Organized</p><p> Manage their time more effectively</p><p> Prioritize their time so they can get it all done.</p><p> Complete Special Tasks</p><p> Verbal Communication Skills</p><p> Non-Verbal Communication Skills</p><p> Module 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ILC started its campus-based educational program in 2013 and in 2016 the college has started its distance learning program and offered various online courses to its international students. Now college has students’ more than 50 countries that are the part of our distance learning program.<br /> ILC’s professional and online diploma courses are accredited by the Training and Qualifications UK (TQUK) and British Awarding Association. Both awarding bodies are highly reputable and are registered with Ofqual. The courses catalogue of Inspire London College is quite extensive which mainly includes the disciplines of project management, hotel management, business administration, accounting and finance, forensic accounting, E-commerce management, event management, construction management, logistics and supply chain management, fashion designing etc.<br /> <br /> Campus-based Studies and Distance Learning<br /> Inspire London College offers the candidates to learn according to their own choice as college offers campus-based education as well as distance learning education. 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To achieve TQUK Endorsed Diploma of Level 7 Business Development and Administration learner must have to achieve 16 Modules with 160 Credits.</p><p> Modules Outline</p><p> Module1: Human Resource Management</p><p> Describe the implications of different aspects of HRM on their daily responsibilities</p><p> Define human resources terms and subject matter</p><p> Recruit, interview, and retain employees more effectively</p><p> Follow up with new employees in a structured manner</p><p> Be an advocate for your employees’ health and safety</p><p> Provide accurate, actionable feedback to employees</p><p> Module2: Communication Strategies</p><p> Understand what communication is</p><p> Identify ways that communication can happen</p><p> Identify barriers to communication and how to overcome them</p><p> Develop their non-verbal and par verbal communication skills</p><p> Use the STAR method to speak on the spot</p><p> Listen actively and effectively</p><p> Module3: Conflict Resolution</p><p> 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picture</p><p> Develop a risk management strategy</p><p> Know how to practice financial literacy</p><p> Develop critical thinking</p><p> Practice management acumen</p><p> Find key financial levers</p><p> Module6: Business Ethics</p><p> Define and understand ethics.</p><p> Understand the benefits of ethics.</p><p> Create strategies to implement ethics at work.</p><p> Recognize social and business responsibility.</p><p> Identify ethical and unethical behavior.</p><p> Learn how to make ethical decisions and lead with integrity.</p><p> Module7: Business Etiquette</p><p> Define etiquette and provide an example of how etiquette can be of value to a company or organization.</p><p> Understand the guidelines on how to make effective introductions.</p><p> Identify the 3 C’s of a good impression.</p><p> Identify at least one way to minimize nervousness while in social situations.</p><p> Understand how to use a business card effectively.</p><p> Identify and practice at least one way to remember names.</p><p> Identify the 3 steps in giving a handshake.</p><p> Module8: Business Development and Succession Planning</p><p> Define business Development and Succession planning and its role in your company.</p><p> Lay the groundwork to develop a Development and Succession plan.</p><p> The importance of mentorship.</p><p> Define and use a SWOT analysis to set goals.</p><p> Create a plan, assign roles, and execute the plan.</p><p> Module9: Facilitation Skills</p><p> Define facilitation and identify its purpose and benefits.</p><p> Clarify the role and focus of a facilitator.</p><p> Differentiate between process and content in the context of a group discussion.</p><p> Provide tips in choosing and preparing for facilitation.</p><p> Module 10: Organisational Skills</p><p> Examine current habits and routines that are not organized</p><p> Learn to prioritize your time schedule and daily tasks</p><p> Determine ways of storing information and supplies</p><p> Module 11: Negotiation Skills</p><p> Understand the basic types of negotiations, the phases of negotiations, and the skills needed for successful negotiating</p><p> Understand and apply basic negotiating concepts: WATNA, BATNA, WAP, and ZOPA</p><p> Lay the groundwork for negotiation</p><p> Identify what information to share and what to keep to yourself</p><p> Understand basic bargaining techniques</p><p> Apply strategies for identifying mutual gain</p><p> Module 12: Crisis Management</p><p> Understand the myths behind workplace violence</p><p> Define escalation and identify examples</p><p> Learn concerning behaviors</p><p> Know what a trigger is and how that can escalate</p><p> Understand the proper response to an event</p><p> Module 13: Administrative Support Skills</p><p> Getting Organized</p><p> Manage their time more effectively</p><p> Prioritize their time so they can get it all done.</p><p> Complete Special Tasks</p><p> Verbal Communication Skills</p><p> Non-Verbal Communication Skills</p><p> Module 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Millions of people around the world are living with rare and serious medical conditions. CSL Behring is committed to delivering medicines that improve their lives. </p><p></p><p> With operations in 35+ nations and ~ 30,000 employees worldwide, CSL is inspired to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment. CSL is the parent company of CSL Behring, CSL Plasma, CSL Seqirus and CSL Vifor. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. </p><p></p><p> Could you be our next Clinical Science Director? This position is located in our King of Prussia PA, Marburg Germany or Bern Switzerland office. It is a Hybrid role. You will report to the Global Clinical Lead. </p><p></p><h2><b> The Opportunity </b></h2><p> You will use your MD degree and Clinical Development experience to take global responsibility for medical oversight of selected pipeline and products within the assigned therapeutic area(s). You will be responsible for.medical standards and processes according to expectations of manufacturers by all partners including regulators, governmental agencies, payors, physicians, patients and the general public. </p><p></p><h2><b> The Role </b></h2><ul><li><p> You will provide medical expertise for clinical study oversight and safety concerns within the assigned therapeutic area as the Medical monitor. Present results to Safety Monitoring Committee and other internal and external meetings. 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الشركة المعلنة عن الوظيفة
CSL Behring
-
Level 7 Business Development and Administration Inspire London College83 درهم
1,714 درهممدة الدورة التدريبية: Upto 12 Months -
Sales and Marketing Diploma Level 3 London Institute of Business & Management65 درهم
698 درهممدة الدورة التدريبية: Upto 1 Day
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