Associate Director/Senior Manager, Clinical Scientist (Allston)

Compensation

: $101,370.00 - $167,060.00 /year *

Employment Type

: Full-Time

Industry

: Scientific Research



Agenus, Inc.
Associate Director/Senior Manager, Clinical Scientist
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Description
The Clinical Scientist is a role responsible for scientific components related to all clinical development activities, from early development to regulatory submission activities for approval. This role will oversee the scientific merit of all assigned clinical activities. It is essential that the new hire is highly proactive, detail-oriented yet has the vision of the overall program, independent yet collaborative and driven. The clinical scientist will report to the head of clinical sciences and medical writing.
Here is what you will do -
Clinical Data Review: support clinical teams in the following activities:
* Conduct regular, ongoing clinical data review for the assigned clinical studies with respect to clinical data quality, integrity, and scientific comprehensiveness. Identify data requiring further assessment and investigation.
* Ensure all clinical endpoints/ parameters are being collected according to regulatory requirements. Ensure data collected answers the clinical questions asked per the study design.
* Participates in tracking/analysis of safety and efficacy signals within a given trial and across trials for assigned program(s) to identify safety signals and risks
* Contribute to the preparation of documentation for any clinical data review meetings, as appropriate
* Review clinical trial adverse events, safety narratives, and assist with safety data reconciliation. Contribute to safety data reconciliation conducted by data management.
* Review clinical trial efficacy data, ensuring compliance with the appropriate tumor assessment tools and with alignment with health authorities' requirements.
* Working closely with the study team, serving as the point of contact for, and triage, clinical study inquiries from site staff, IRBs, CROs and site monitors regarding the study protocol, modifications to informed consent, and patient-specific questions related to the clinical, medical and scientific content of the protocols and program
Clinical and Regulatory Development support:
* Prepare clinical output summary reports, PowerPoint presentations of the clinical data, clinical trial synopses, patient profiles as required for program activities. Advise on study analytical/data strategy
* Create, contribute and/or review clinical slides for internal and external meetings (i.e. Investigator Meetings, PSSV and SIVs, Study Coordinator and CRA training, Advisory Boards, scientific meetings). May also participate in or lead, as appropriate training of study site personnel.
* Prepare targeted reviews/profiles of outliers, search and summarize information relevant for various clinical documents preparation.
* Lead, in conjunction with appropriate functions, preparation of clinical study documents, including Clinical Study Reports, safety narratives, clinical study protocols, protocol amendments. Support development of Statistical Analysis Plans, CRFs, instructions for unique CRFs, and data quality plan as well as study publications (abstracts/posters/manuscripts) and other related clinical study documentation.
* Lead development of clinical sections of program level regulatory documents such as Investigator's Brochures, briefing books, safety updates, IND/NDA/BLA submission documents, responses to Health Authorities questions.
* Participate in Clinical Development Plan (CDP) establishment and periodic updates
* As assigned, participate in the development of the long-range strategic plans for the assigned program(s).
* As assigned, participate in the assessment of in-licensing opportunities
* May participate in Health Authority interactions
* May present at ad boards and other external forums
* Review scientific and medical literature to address clinical needs/ assess disease background, conduct literature searches, and reference compilation. Keep abreast of pertinent developments in the related medical field.
Cross-Functional Team Interaction and Team Leadership
* Provide relevant clinical scientist expertise to internal teams, including clinical operations, medical writing, data management, biostatistics and programming, pharmacovigilance, and other teams as necessary, to ensure quality processes and deliverables. Leads some of the teams as appropriate.
* Serve as a resource to address clinical questions or clarify issues arising during the conduct of the study
* Serve as a primary point of contact and resource for study clinical inquiries (e.g., from internal function reps or CROs)
* Participate/contribute to cross-functional team meetings.
* Helps ensure cross-functional integration, coordination and alignment to enable effective and efficient CDP execution
Within the Clinical sciences group
* Collaborate with other clinical scientists and other members of the group to ensure consistency among programs.
* Provide cover and support when needed to other clinical programs in another scientist's absence.
+ Empower and represent the clinical sciences function in the clinical development organization.
Requirements
* Advanced clinical/science degree required (PharmD, Ph.D., MSN, MPH, etc.).
* Generally, 5 or more years pharma/biotech industry experience in clinical development with the majority of the experience in the clinical scientist role or similar position.
* 2 or more years relevant therapeutic area experience required
* Experience authoring clinical trial protocols and clinical study reports, as well as preparing study results presentations, and formulating data analysis conclusions
* In-depth understanding of all drug development phases.
* Experience working with the principles and techniques of data analysis, interpretation, and assessment of clinical relevance
* Comprehensive understanding of product and safety profiles
* Well-versed in medical aspects of GCP (Good Clinical Practice), ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMEA, and other relevant guidelines and regulations
* Preferred: Experience publishing clinical trial results in peer-reviewed journals
Abilities:
* Proven abilities to perform CS responsibilities independently and with limited guidance. Has demonstrated, through past experience, abilities to competently manage the majority of CS deliverables associated with assigned clinical studies
* Has impeccable ethics. Demonstrates, or proven abilities to demonstrate gRED values
* Outstanding attention to detail yet has the ability to see the "big picture"
* Strong industry acumen; has in-depth knowledge of the multidisciplinary functions involved in a company's drug development process, e.g., clinical operations, biostatistics, regulatory, commercial operations, etc. and can proactively integrate multiple perspectives into the clinical development process for best end-results
* Excellent leadership and project management skills: can prioritize multiple tasks and goals and deliver them in a timely, on-target and high-quality manner within budget guidance
* Excellent interpersonal, verbal communication and influencing skills: can influence without authority and has proven experience building and cultivating relationships with key partners and stakeholders, both internally and externally
* Outstanding general and scientific written communication skills
* Proven experience building and cultivating relationships with key partners and stakeholders, both internally and externally
* Ability to work in a fast-paced environment and manage multiple competing demands
* Strong presentation skills: effective at summarizing and presenting the key considerations and decision-points
* Confident and competent when interacting with varying levels of internal/external management, key opinion leaders (KOLs), etc.; stays focused and on-point, is able to raise problems or challenges in a productive and mature manner
* Excellent teamwork and negotiation skills: knows how to complete deliverables by working effectively with others internally and externally; can effectively drive discussions and decisions toward desired end-results
* It is expected that CS will take initiative and work independently, however, ongoing communication with other team functions is a required part of problem-solving and decision-making. Consistently and effectively identifies and addresses important factors affecting the clinical trial design and execution
* Ability to travel globally (<30%)
Job Information
* Location:
Lexington, Massachusetts, United States
* Job ID:
51125118
* Posted:
October 9, 2019
* Position Title:
Associate Director/Senior Manager, Clinical Scientist
* Company Name:
Agenus, Inc.
* Job Function:
Research
* Entry Level:
No
* Job Type:
Full-time
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* Advanced clinical/science degree required (PharmD, Ph.D., MSN, MPH, etc.). * Generally, 5 or more years pharma/biotech industry experience in clinical development with the majority of the experience in the clinical scientist role or similar position. * 2 or more years relevant therapeutic area experience required * Experience authoring clinical trial protocols and clinical study reports, as well as preparing study results presentations, and formulating data analysis conclusions * In-depth understanding of all drug development phases. * Experience working with the principles and techniques of data analysis, interpretation, and assessment of clinical relevance * Comprehensive understanding of product and safety profiles * Well-versed in medical aspects of GCP (Good Clinical Practice), ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMEA, and other relevant guidelines and regulations * Preferred: Experience publishing clinical trial results in peer-reviewed journals Abilities: * Proven abilities to perform CS responsibilities independently and with limited guidance. Has demonstrated, through past experience, abilities to competently manage the majority of CS deliverables associated with assigned clinical studies * Has impeccable ethics. Demonstrates, or proven abilities to demonstrate gRED values * Outstanding attention to detail yet has the ability to see the "big picture" * Strong industry acumen; has in-depth knowledge of the multidisciplinary functions involved in a company's drug development process, e.g., clinical operations, biostatistics, regulatory, commercial operations, etc. and can proactively integrate multiple perspectives into the clinical development process for best end-results * Excellent leadership and project management skills: can prioritize multiple tasks and goals and deliver them in a timely, on-target and high-quality manner within budget guidance * Excellent interpersonal, verbal communication and influencing skills: can influence without authority and has proven experience building and cultivating relationships with key partners and stakeholders, both internally and externally * Outstanding general and scientific written communication skills * Proven experience building and cultivating relationships with key partners and stakeholders, both internally and externally * Ability to work in a fast-paced environment and manage multiple competing demands * Strong presentation skills: effective at summarizing and presenting the key considerations and decision-points * Confident and competent when interacting with varying levels of internal/external management, key opinion leaders (KOLs), etc.; stays focused and on-point, is able to raise problems or challenges in a productive and mature manner * Excellent teamwork and negotiation skills: knows how to complete deliverables by working effectively with others internally and externally; can effectively drive discussions and decisions toward desired end-results * It is expected that CS will take initiative and work independently, however, ongoing communication with other team functions is a required part of problem-solving and decision-making. Consistently and effectively identifies and addresses important factors affecting the clinical trial design and execution * Ability to travel globally (<30%)


Associated topics: biology, biomechanics, biomedical engineer, enzyme, neuro, neurodegenerative, nutrition, pain, pharmaceutical, therapeutic * The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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