Clinical Development Director
vor 1 Tag
22 the number of oncology drugs we have on the market and more than 25 new molecular entities in development targeting key molecular pathways in cancer biology.
- As our Clinical Development Director (CDD), you will be responsible for the scientific and clinical strategy of assigned clinical trials, scientific monitoring, and reporting of quality data. In addition, you may be responsible for the clinical and scientific strategy of assigned sections of a clinical development program, depending on the size and complexity.
- Your responsibilities include, but are not limited to:
- Provide clinical leadership, medical and scientific strategic input, and contribute to development of trial related documents (e.g., CTPs, informed consent form, case report forms, data monitoring committee charters, data analysis plan, reports, publications) for assigned clinical trial(s) consistent with Integrated Development Plan (IDP); develop materials for trial-related advisory boards, data monitoring committees, investigators meetings, and protocol training meetings for Novartis local medical organizations.
- Provide clinical and scientific input and contribute to clinical sections of trial and program level regulatory documents (e.g., Investigator’s Brochures, Health Authority briefing books, safety updates, submission dossiers, and responses to Health Authorities).
- In collaboration with appropriate Clinical Trial Team (CTT) members: Ensure clinical support of trials as needed; conduct ongoing medical and scientific review of clinical trial data with Clinical Scientific Expert(s) with appropriate oversight from Medical Lead; manage patient safety reports on trial data to safety and clinical boards (e.g., Safety Management Team (SMT), GCT, GPT) with appropriate oversight from Medical Lead; provide input into final analyses and interpretation including the development of the Clinical Study Report(s) (CSRs), publications and internal/external presentations.
- Support Therapeutic Area Head (TAH) with contributing to peer-review of IDPs, CTPs, and other clinical documents across various indications and programs, and support development of TA strategies, as needed.
- May contribute to the medical and scientific evaluation for Business Development & Licensing (BD&L) opportunities.
- Contribute to talent and career development of CD associates through on-boarding, coaching, and/or mentoring support; develop and foster CD culture; and may contribute to the performance evaluation of CTT members.
- Contribute to medical/scientific training of relevant Novartis stakeholders on the disease area and compound/molecule. May serve as speaker for franchise medical/scientific training.
- Contribute to global initiatives (e.g., process improvement, training, SOP development, other Clinical Development line function initiatives).
**Commitment to Diversity & Inclusion**:
- Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._
**Minimum requirements**
- Advanced degree in life sciences/ healthcare (or clinically relevant degree) is required.
- 5+ years of involvement in clinical research or drug development in an academic or industry environment spanning clinical activities in Phases I through IV; 2 or more years of contribution to and accomplishment in all aspects of conducting clinical trials (e.g. planning, executing, reporting and publishing) in a global/matrix environment in pharmaceutical industry.
- Proven ability to interpret, discuss and present efficacy and safety data relating to clinical trial(s) or program level.
- Working knowledge of the disease area is desired with proven ability to interpret, discuss and present efficacy and safety data relating to clinical trial(s) or program level
- Working knowledge of GCP, clinical trial design, statistics, and regulatory and clinical development processes.
Desirable requirements:
- PharmD, or PhD strongly preferred
Why consider Novartis?
769 million. That’s how many lives our products touched in 2020. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.
Imagine what you could do at Novartis
**Division**
- Global Drug Development
**Business Unit**
- OHD GDD
**Country**
- Switzerland
**Work Location**
- Basel
**Company/Legal Entity**
- Novartis Pharma AG
**Alternative Country 1**
- USA
**Functional Area**
- Research & Development
**Job
-
Clinical Development Medical Director
Vor 6 Tagen
Basel, Schweiz Hobson Prior VollzeitHobson Prior are currently looking for a Clinical Development Medical Director to join a brilliant pharmaceutical organisation on a contract basis located in Basel. For more information, please get in touch now! Please note that to be considered for this role you must have the right to work in this location. **Key Responsibilities**: - For this role, you...
-
Clinical Development Director
Vor 2 Tagen
Basel, Schweiz Novartis Vollzeit1! One person dies every 37 seconds from Cardiovascular Disease in the United States. At Novartis, we are committed to reducing the global burden of cardiovascular, renal and metabolic diseases on patients, families and their communities. We are focused on developing solutions targeting heart failure (acute and chronic), atherosclerosis, metabolic and renal...
-
Clinical Project Director
Vor 2 Tagen
Basel, Schweiz Global Personal Partner Vollzeit**EINFÜHRUNG**: Our profession and our passion "HR Management." Global Personal is an independent company of the Interiman Group SA with over 100 employees offering a complete range of human resources services at 21 locations in German-speaking Switzerland. For our client, an international orientated Pharma company in Basel we are looking for a reliable...
-
Medical Director, Clinical Pharmacology
vor 1 Tag
Basel, Schweiz Novartis VollzeitTM Clinical Pharmacology is a cross-functional team, which is specialized on the design, clinical execution and reporting of First-in-Human (FiH) and Clinical Pharmacology studies across all TM therapeutic areas. The operating model is built upon a strategic outsourcing partnership with qualified and specialized CROs, in which the Novartis team maintains...
-
Director (or Senior Director) Non-Clinical PK/PD
Vor 3 Tagen
Basel, Schweiz Hlx Life Sciences VollzeitDirector (or Senior Director) Non-Clinical PK/PDA leading biotech company is seeking an experienced and highly motivated scientist to lead PK/PD activities within its Non-Clinical Development (NCD) team. This role offers the opportunity to make an immediate impact on the development of a growing pipeline of novel therapies by contributing expertise to both...
-
Basel, Schweiz Novartis Vollzeit22! the number of oncology drugs we have on the market and more than 25 new molecular entities in development targeting key molecular pathways in cancer biology. And while we’re proud of that, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives? -...
-
(Associate) Director, Clinical Quality Assurance
vor 1 Woche
Basel, Schweiz IMVT Corporation Vollzeit**Organizational Overview**: Immunovant, Inc. is a clinical-stage biopharmaceutical company dedicated to enabling normal lives for people with autoimmune diseases. As a leader in FcRn inhibitor technology, we are boldly developing innovative therapies for a range of debilitating autoimmune diseases with significant unmet patient needs. Our investigational...
-
Global Clinical Development Lead
Vor 4 Tagen
Basel, Schweiz NonStop Consulting VollzeitWe are looking for a Clinical Development Medical Director (CDMD) who is responsible for leading the strategic planning and management of the assigned clinical programs from an end-to-end clinical development perspective. As the CDMD, you will oversee the clinical development of the assigned programs and drive the implementation of the clinical development...
-
Clinical Development Head
Vor 5 Tagen
Basel, Schweiz Novartis Vollzeit20 million people. That’s how many people lose their lives to cardiovascular, renal and metabolic diseases each year. At Novartis we are committed to finding ways that could reduce the impact of these diseases on patients, their families and their communities. Patients are at the centre of everything we do and inspire our purpose. The Clinical Development...
-
Medical Director Clinical Science
Vor 3 Tagen
Basel, Schweiz Sobi group VollzeitAssociate Medical Director Clinical ScienceFull-timeSobi Location: United StatesStatistics show that women and underrepresented groups tend to apply to jobs only if they meet 100% of the qualifications. Sobi encourages you to change that statistic and apply. Rarely do candidates meet 100% of the qualifications. We look forward to your application!At Sobi,...
-
Clinical Development Leader
Vor 2 Tagen
Basel, Basel-Stadt, Schweiz Roche VollzeitJob DescriptionWe are seeking an experienced Medical Director who will lead and/or support early-stage clinical projects from entry into a human through proof of mechanism and proof of concept. You will leverage your expertise to translate innovative molecules into potentially transformative therapies for patients with severe brain disorders. By marrying...
-
Associate Director or Director of Pharmacometrics
vor 5 Stunden
Basel, Schweiz Hengrui Europe Therapeutics AG Vollzeit**Job Title**: Associate Director or Director of Pharmacometrics **Reports to (Title)**: Head of Pharmacometrics **Location**: Basel Switzerland **Direct Reports**: No **Department**: Clinical Pharmacology & Early Development **About Hengrui**: The Hengrui ex-China organization drives the development and commercialization of the Hengrui innovative...
-
Clinical Development Strategist
Vor 6 Tagen
Basel, Basel-Stadt, Schweiz Genentech VollzeitAt Genentech, we advance science so that we all have more time with the people we love. We are a leading biotechnology company dedicated to delivering innovative medical solutions. Our Clinical Development organization is structured by therapeutic area and is responsible for developing and executing late-stage development clinical strategies and plans to...
-
Associate Director or Director of Pharmacometrics
vor 5 Stunden
Basel, Schweiz Luzsana Biotechnology (Part of Hengrui) Vollzeit**Job Title**: Associate Director or Director of Pharmacometrics **Reports to (Title)**: Head of Pharmacometrics **Location**: Basel Switzerland **Direct Reports**: No **Department**: Clinical Pharmacology & Early Development Luzsana Biotechnology (Luzsana) is a global, purpose-driven innovative medicines company with the mission to deliver medicines...
-
Clinical Scientist, Early Development Oncology
Vor 3 Tagen
Basel, Schweiz Roche VollzeitRoche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche,...
-
Clinical Scientist, Early Development Oncology
Vor 2 Tagen
Basel, Schweiz Roche VollzeitRoche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche,...
-
Associate Director Cmc of Technical Development
Vor 7 Tagen
Basel, Schweiz Hobson Prior VollzeitHobson Prior are currently looking for an Associate Director CMC of Technical Development to join a brilliant biotech organisation on a permanent basis located in Basel. Our client is focused on producing the next generation of multifunctional accuracy immunotherapies. Please note that to be considered for this role you must have the right to work in this...
-
Clinical Research and Development Scientist
Vor 2 Tagen
Basel, Basel-Stadt, Schweiz Roche VollzeitJob DescriptionThis position is located within our Roche Pharma Research and Early Development (pRED) organization, dedicated to the clinical development of novel cancer therapeutics. We collaborate closely with various functions, including Therapeutic Modalities, Discovery, Medical and Biomarker Clinical Leaders, Pharmaceutical Sciences, Data Strategy and...
-
Senior Clinical Development Manager, Immunology
vor 1 Woche
Basel, Basel-Stadt, Schweiz Roche VollzeitJob Description:The PositionWe advance science to improve patient outcomes.Genentech's Product Development Clinical Science organization is structured by therapeutic area and focuses on developing and executing late-stage development strategies to deliver innovative therapies. The Lead Clinical Scientist plays a critical role in the clinical science aspects...
-
Clinical Scientist, Early Development Oncology
Vor 3 Tagen
Basel, Schweiz F. Hoffmann-La Roche Gruppe VollzeitRoche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people’s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche,...
