- May function as lead Clinical Scientist for program, and/or as delegate of Therapeutic area Lead Clinical Scientist
- Contributes to program team meetings, scientific advisory boards, study steering committees and data/safety monitoring meetings; may represent function in collaborative activities with other departments; Member of the Clinical Study Team and Global Clinical SubTeam
- Maintains proficient understanding of therapeutic disease area(s) and drug candidate including underlying disease biology, clinical manifestations and therapeutic standard practice, compound(s) including mechanism of action and drug landscape as well as maintaining compliance in accordance with FDA, EMEA, ICH and GCP guidelines as well as applicable SOPs regarding clinical safety
- Possesses proficient scientific expertise to propose, design, and execute clinical research and development studies for early and/or late stage assets; able to conceive and communicate strategy proposals well-grounded in supporting literature.
- Develops the Expanded Synopsis and authors clinically relevant sections and reviews other scientific portions of clinical trial protocols and amendments
- Authors and/or reviews documents related to trials, such as medical monitoring plans, SAPs, informed consents and clinical components of the Clinical Study Reports with minimal guidance and supports the development of regulatory documents; performs quality review and may approve; adjudicate and resolve cross functional comments with minimal support
- Leads planning and prepares information for external /stakeholder meetings (IM, Governance, DMCs, Regulatory Authority); Presents data and information to external investigators (SIV) and internal stakeholders
- Performs clinical/medical data review, including safety monitoring and activities and procedures that ensure patient safety
- Proficient analytical knowledge and skills to understand how program objectives and design impact data analysis; Identifies risks and designs mitigation strategies
- Promotes consistent first line medical/clinical data review techniques and conventions across studies/programs; Reviews clinical data review plan and authors medical monitoring plan for assigned studies/program
- Ability to lead activities within a matrix environment; Exhibits confidence and professional diplomacy, while effectively relating to people at all levels internally and externally; Demonstrated ability to Influence within team and may influence across functionally
- Demonstrates initiative, creativity and innovation skills. Directly or indirectly contributes to the development of innovations; Identifies opportunities for process improvements.
- Resolves novel problems requiring creative application of advanced skill, training, and education
- May serve as a peer coach learning how to mentor and provides guidance to junior members of department and cross-functional team members as appropriate
-
Regeneron Pharmaceuticals, Inc. Basking Ridge, United States Full timeWe are seeking a Associate Director to join out Oncology Clinical Development department. The Associate Director Clinical Sciences leads in the development, evaluation, planning and execution of clinical studies and ensures scientific integrity and interpretation of study data of ...
-
Clinical Scientist, Oncology
4 days ago
Bristol-Myers Squibb Princeton, NJ, United StatesWorking with UsChallenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line t ...
-
Johnson & Johnson Somerville, United StatesJob Description · At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing, and preventing some of the most devastating and complex diseases of our time. · Janssen Research & Devel ...
-
Johnson & Johnson Somerville, United StatesJob Description · Principal Medical Writing Scientist, Oncology At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing, and preventing some of the most devastating and complex di ...
-
Associate Clinical Scientist, Oncology
4 weeks ago
Bristol Myers Squibb Princeton, United StatesWorking with Us · Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production lin ...
-
Associate Clinical Scientist, Oncology
4 weeks ago
BioSpace Princeton, United StatesJob Details · Working with Us · Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a ...
-
Associate Clinical Scientist, Oncology
4 weeks ago
Bristol Myers Squibb Princeton, United States OTHERWorking with Us · Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production lin ...
-
Bristol Myers Squibb Princeton, United States Full timeWorking with Us · Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production li ...
-
Bristol Myers Squibb Princeton, United States Full timeWorking with Us · Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production li ...
-
Tempus New York, United StatesPassionate about precision medicine and advancing the healthcare industry? · Recent advancements in underlying technology have finally made it possible for AI to impact clinical care in a meaningful way. Tempus' proprietary platform connects an entire ecosystem of real-world evid ...
-
Bristol Myers Squibb Princeton, United States OTHERWorking with Us · Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production lin ...
-
Bristol-Myers Squibb Company Princeton, United States**Working with Us**Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production li ...
-
Bristol-Myers Squibb Company Princeton, United States**Working with Us**Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production li ...
-
Regeneron Pharmaceuticals, Inc Bernards, United States Full timeThe Associate Director, Clinical Scientist leads in the development, evaluation, planning and execution of hematology oncology clinical studies and ensures scientific integrity and interpretation of study data of a clinical development program. Leads in a matrix environment as pa ...
-
Memorial Sloan Kettering Cancer Center Bernards, United States OTHERCompany Overview The people of Memorial Sloan Kettering Cancer Center (MSK) are united by a singular mission: ending cancer for life. Our specialized care teams provide personalized, compassionate, expert care to patients of all ages. Informed by basic research done at our Sloan ...
-
Advanced Practice Provider
1 week ago
Memorial Sloan Kettering Cancer Center Bernards, United States$130,700.00-$215,800.00 · Company Overview · The people of Memorial Sloan Kettering Cancer Center (MSK) are united by a singular mission: ending cancer for life. Our specialized care teams provide personalized, compassionate, expert care to patients of all ages. Informed by basic ...
-
Memorial Sloan Kettering Cancer Center Careers Bernards, United States Permanent, Full timeCompany Overview: The people of Memorial Sloan Kettering Cancer Center (MSK) are united by a singular mission: ending cancer for life. Our specialized care teams provide personalized, compassionate, expert care to patients of all ages. Informed by basic research done at our Sloan ...
-
BioSpace Basking Ridge, United StatesJob Details · Join a Legacy of Innovation 110 Years and Counting Company is committed to diversity and inclusion. We are an equal opportunity employer including veterans and people with disabilities. SummaryThis position will be the Clinical Science Group Lead in late phase devel ...
-
Daiichi Sankyo Basking Ridge, United StatesJob Description · Join a Legacy of Innovation 110 Years and Counting Company is committed to diversity and inclusion. We are an equal opportunity employer including veterans and people with disabilities. SummaryThis position will be the Clinical Science Group Lead in late phase d ...
-
Daiichi Sankyo Inc. Basking Ridge, United StatesJoin a Legacy of Innovation 110 Years and Counting · Company is committed to diversity and inclusion. We are an equal opportunity employer including veterans and people with disabilities. · SummaryThis position will be the Clinical Science Group Lead in late phase development in ...
Associate Director, Clinical Scientist, Oncology - Bernards, United States - Regeneron Pharmaceuticals, Inc
Description
We are seeking a Associate Director to join out Oncology Clinical Development department. The Associate Director Clinical Sciences leads in the development, evaluation, planning and execution of clinical studies and ensures scientific integrity and interpretation of study data of a clinical development program. The Associate Director leads in a matrix environment as part of a cross-functional team and may contribute to candidate development projects through early and/or late phase development. The Associate Director reports to the Director, Clinical Sciences and collaborates closely with Medical Director(s) (MDs) to provide scientific expertise necessary to design and deliver on clinical studies and programs.
As an Associate Director a typical day may include the following:
This role may be for you if:
To be considered for this role, you must have a Bachelor's Degree; Advanced degree or equivalent education/degree in life science/healthcare preferred (PhD/MD/PharmD/MSc) is preferred. ≥ 10 years of pharmaceutical clinical drug development experience. Other levels considered depending on experience. We are seeking proven leadership experience and accomplishment in all aspects of conducting global clinical trials and execution of clinical programs. Strong cross-functional management, interpersonal and problem-solving skills. Proficient knowledge of clinical development process, regulatory requirements and ICH/GCP guidelines.
