Job Description:
Assoc. Principal Scientist, Early Clinical Research-CLI003704<br/> Description<br/><br/>
Merck is a global health care leader with a diversified portfolio of prescription medicines, and vaccines, as well as animal health products. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.<br/>
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of people like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
The Early Clinical Scientist/ECS provides leadership and therapeutic expertise for the design, planning and execution of early phase clinical trials with the Clinical Director and internal/external team members. Responsible for oversight, strategic direction and implementation of multiple trials within and/or across program(s)/therapeutic areas to ensure excellence in execution/compliance to support study objectives and data validity. Ensures consistency for all clinical program elements. Manages CRO performance to achieve project objectives and resolves project performance issues if they arise.
Ensures appropriate clinical safety assessment and risk management of compounds. Conducts real-time oversight of ongoing trials to identify and mitigate patient, study design, data or study conduct issues. Reviews and interprets clinical trial data. May conduct on-site study monitoring, including site training & supervision of complex, novel endpoint/biomarker collection processes. Applies thorough knowledge of GCP, ICH guidelines and regulatory requirements for clinical development.
Represents Early Stage Development on early development teams (EDT) and product development teams (PDT).
- Directs the development of departmental job aids/SOP and participates or leads cross-functional teams to develop clinical development procedures.
- Identifies and communicates best practices within the organization. Promotes departmental adaptation of new procedures.
- Builds talent and capabilities of junior team members through proactive coaching, mentoring and development opportunities.
- Represents the company at professional events and may present company clinical initiatives, projects, and/or clinical trial results.
Technical Writing & Communications
- Responsible for authoring of clinical protocols, clinical investigator brochures, clinical study reports, regulatory agency update reports, responses to regulatory agencies, responses to audits/inspections, and other clinical and regulatory documents.
- Author and coordinate the development of Worldwide Marketing Application/Common Technical Document (WMA/CTD) subsections.
- Assist the Clinical Directors in scientific leadership/investigator initiatives including preparation of publications, meeting presentations, due diligence activities, etc.
- Ensures documents are completed in accordance with applicable standards.
- Develops study operational documents with input from team members (e.g. site monitoring plan, study operations manual, informed consent, etc.).
Project Management
* Leads and directs teams in key study planning, development and execution elements (e.g., program level overviews, issue escalation/mitigations, presentations at Sr. Management meetings, program level cross-functional meetings and governance, advisory meeting preparation).
* Manages trial and program projects including team activities (i.e. meetings, document/collaborative workspace management, etc.), provides risk assessment and contingency planning, under accelerated timelines.
* Thorough understanding of early drug development processes, applying knowledge and skills to effectively manage additional processes/procedures.
Qualifications
Education:
* Required: Bachelor of Science degree and 11-15 years related experience
* Preferred: Master’s degree and 8-12 years related experience e.g., clinical drug development, clinical trial management, clinical site training/monitoring; medical and regulatory writing
Required Experience:
- Experience must include at least 6 years early phase/translational medicine research and development experience
- Ability to solve complex problems and use independent judgment relating to regulations, guidelines, investigator interactions
- Ability to quickly develop a working scientific knowledge of different therapeutic areas
- Ability to successfully develop, implement, manage and complete complex clinical trials and manage vendor relations under accelerated timelines
- Demonstrated excellence in complex project management and effectively managing multiple projects/priorities is required
- Demonstrated excellence in scientific, medical/safety writing, and reporting
- Ability to independently work across all functional areas to make data-driven decisions as well as proactively identify, appropriately escalate, and plan for mitigations to potential problems, situations or issues within a study, program or key initiatives
- Proven ability to partner effectively with external (CRO) teams to achieve results
- Effective communication (written and oral), problem solving and analytical skills
- Experience with presentations before executive staff
- Working knowledge of GCP, ICH guidelines and regulatory requirements
- Ability to mentor junior staff is required
- Works effectively across boundaries, applying understanding of cultural differences to communication and collaboration practices
- Demonstrated leadership or participation in a cross-functional initiative to address a business gap or process improvement
- Must act with courage and candor
Preferred Experience:
* An advanced degree is desirable. Global Phase I patient trials, safety reporting, and regulatory NDA/WMA submission experience a plus.
Our employees are the key to our company’s success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Merck’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. If you need an accommodation for the application process please email us at staffingaadar@merck.com.
Search Firm Representatives - Please read carefully:
Merck is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via-email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means. ZZ5ML
Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.
Job: Clinical Research (Non-M.D.)
Job Title:Assoc Prin. Scientist, Clinical Research
Primary Location: NA-US-NJ-Rahway
Other Locations: NA-US-PA-Upper Gwynedd, NA-US-MA-Boston
Employee Status: Regular
Travel: Yes, 5 % of the Time
Number of Openings: 1
Shift (if applicable): 1st
Additional Info:
[Click Here to Access the Original Job Post]
Assoc. Principal Scientist, Early Clinical Research-CLI003704<br/> Description<br/><br/>
Merck is a global health care leader with a diversified portfolio of prescription medicines, and vaccines, as well as animal health products. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.<br/>
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity and teamwork of people like you. To this end, we strive to create an environment of mutual respect, encouragement and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
The Early Clinical Scientist/ECS provides leadership and therapeutic expertise for the design, planning and execution of early phase clinical trials with the Clinical Director and internal/external team members. Responsible for oversight, strategic direction and implementation of multiple trials within and/or across program(s)/therapeutic areas to ensure excellence in execution/compliance to support study objectives and data validity. Ensures consistency for all clinical program elements. Manages CRO performance to achieve project objectives and resolves project performance issues if they arise.
Ensures appropriate clinical safety assessment and risk management of compounds. Conducts real-time oversight of ongoing trials to identify and mitigate patient, study design, data or study conduct issues. Reviews and interprets clinical trial data. May conduct on-site study monitoring, including site training & supervision of complex, novel endpoint/biomarker collection processes. Applies thorough knowledge of GCP, ICH guidelines and regulatory requirements for clinical development.
Represents Early Stage Development on early development teams (EDT) and product development teams (PDT).
- Directs the development of departmental job aids/SOP and participates or leads cross-functional teams to develop clinical development procedures.
- Identifies and communicates best practices within the organization. Promotes departmental adaptation of new procedures.
- Builds talent and capabilities of junior team members through proactive coaching, mentoring and development opportunities.
- Represents the company at professional events and may present company clinical initiatives, projects, and/or clinical trial results.
Technical Writing & Communications
- Responsible for authoring of clinical protocols, clinical investigator brochures, clinical study reports, regulatory agency update reports, responses to regulatory agencies, responses to audits/inspections, and other clinical and regulatory documents.
- Author and coordinate the development of Worldwide Marketing Application/Common Technical Document (WMA/CTD) subsections.
- Assist the Clinical Directors in scientific leadership/investigator initiatives including preparation of publications, meeting presentations, due diligence activities, etc.
- Ensures documents are completed in accordance with applicable standards.
- Develops study operational documents with input from team members (e.g. site monitoring plan, study operations manual, informed consent, etc.).
Project Management
* Leads and directs teams in key study planning, development and execution elements (e.g., program level overviews, issue escalation/mitigations, presentations at Sr. Management meetings, program level cross-functional meetings and governance, advisory meeting preparation).
* Manages trial and program projects including team activities (i.e. meetings, document/collaborative workspace management, etc.), provides risk assessment and contingency planning, under accelerated timelines.
* Thorough understanding of early drug development processes, applying knowledge and skills to effectively manage additional processes/procedures.
Qualifications
Education:
* Required: Bachelor of Science degree and 11-15 years related experience
* Preferred: Master’s degree and 8-12 years related experience e.g., clinical drug development, clinical trial management, clinical site training/monitoring; medical and regulatory writing
Required Experience:
- Experience must include at least 6 years early phase/translational medicine research and development experience
- Ability to solve complex problems and use independent judgment relating to regulations, guidelines, investigator interactions
- Ability to quickly develop a working scientific knowledge of different therapeutic areas
- Ability to successfully develop, implement, manage and complete complex clinical trials and manage vendor relations under accelerated timelines
- Demonstrated excellence in complex project management and effectively managing multiple projects/priorities is required
- Demonstrated excellence in scientific, medical/safety writing, and reporting
- Ability to independently work across all functional areas to make data-driven decisions as well as proactively identify, appropriately escalate, and plan for mitigations to potential problems, situations or issues within a study, program or key initiatives
- Proven ability to partner effectively with external (CRO) teams to achieve results
- Effective communication (written and oral), problem solving and analytical skills
- Experience with presentations before executive staff
- Working knowledge of GCP, ICH guidelines and regulatory requirements
- Ability to mentor junior staff is required
- Works effectively across boundaries, applying understanding of cultural differences to communication and collaboration practices
- Demonstrated leadership or participation in a cross-functional initiative to address a business gap or process improvement
- Must act with courage and candor
Preferred Experience:
* An advanced degree is desirable. Global Phase I patient trials, safety reporting, and regulatory NDA/WMA submission experience a plus.
Our employees are the key to our company’s success. We demonstrate our commitment to our employees by offering a competitive and valuable rewards program. Merck’s benefits are designed to support the wide range of goals, needs and lifestyles of our employees, and many of the people that matter the most in their lives. If you need an accommodation for the application process please email us at staffingaadar@merck.com.
Search Firm Representatives - Please read carefully:
Merck is not accepting unsolicited assistance from search firms for this employment opportunity. Please, no phone calls or emails. All resumes submitted by search firms to any employee at Merck via-email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of Merck. No fee will be paid in the event the candidate is hired by Merck as a result of the referral or through other means. ZZ5ML
Merck is an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.
Job: Clinical Research (Non-M.D.)
Job Title:Assoc Prin. Scientist, Clinical Research
Primary Location: NA-US-NJ-Rahway
Other Locations: NA-US-PA-Upper Gwynedd, NA-US-MA-Boston
Employee Status: Regular
Travel: Yes, 5 % of the Time
Number of Openings: 1
Shift (if applicable): 1st
Skills :
Areas :
Additional Info:
[Click Here to Access the Original Job Post]