Alterome
Associate Director/Director, Clinical Scientist
Alterome, San Diego, California, United States, 92189
About Alterome:
Alterome Therapeutics, Inc. was formed in December 2021 and officially launched operations in January 2022. We are a precision oncology biotech developing alteration-specific therapeutics to address high-value and validated oncogenic drivers. The company is led by a team of experienced leaders with a history of developing marketed oncology small molecule drugs. Alterome recently secured $132 million in Series B funding.
Job Summary:
We are seeking an Associate Director/Director, Clinical Scientist to join our Oncology Clinical Development team. The Associate Director/Director, Clinical Scientist will contribute to the development, planning and execution of one or more clinical studies and ensure scientific integrity and interpretation of study data of the clinical program(s). In this position, you will have the opportunity to develop your leadership, technical and critical thinking skills, and scientific acumen as a part of a cross-functional team. The Associate Director/Director, Clinical Scientist will report to and collaborate closely with the Senior Medical Director.
How You’ll Contribute to the Team:
Provide scientific guidance and support to the team, working in close collaboration with the study medical monitor.
Responsible for overseeing multiple studies and for various aspects of clinical study execution including protocol writing, building study infrastructure, staff training, data cleaning/analysis, investigator interaction and support of regulatory filings.
Integrates scientific knowledge and operational expertise to ensure translation of clinical research plans into efficiently delivered high quality studies.
Maintains proficient understanding of therapeutic disease area(s) and drug candidate, including underlying disease biology, therapeutic standard practice, compound(s) including mechanism of action and drug landscape.
Possesses proficient scientific expertise to propose, design and execute clinical studies for early and/or late-stage assets.
Coordinates with cross-functional teams to produce the final protocol, informed consent documents, and other clinical documents.
Contributes significantly to the development of CRFs, edit checks, and data trend analysis.
Leads and performs clinical/medical data review, including ongoing data cleaning (e.g., data review, query generation, protocol deviation review, SAE reconciliation, patient profile design and review).
Leads and prepares information for external/stakeholder meetings (e.g., Phase 1 Investigator meetings, Safety Review Committees, Governance, DMCs, Regulatory Authority) as directed by the medical monitor; Presents data and information to external investigators (e.g., SIV, Investigator Meetings) and internal stakeholders.
Researches and summarizes scientific information available in published literature for continual self-learning and to prepare training, study manual, and/or investigator meeting materials.
Contributes to statistical analysis plans, table, listing, figure design and the preparation of manuscripts and other presentations of study data.
Addresses site questions regarding protocol and related scientific issues.
Assists in writing or reviewing briefing books, health authority requests for information, IND annual reports, Investigator Brochures, and other regulatory documents.
Supports priorities within the functional area and contributes to or leads department initiatives as requested.
Performs additional duties as assigned.
Required Qualifications:
Bachelor’s Degree; Advanced degree or equivalent education/degree in life science/healthcare (e.g., PhD/PharmD/MSc) is preferred.
≥ 8 years of pharmaceutical clinical drug development experience, other levels considered depending on experience.
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.
Solid communication, technical writing and presentation skills.
Analytical skills with the ability to interpret clinical trial data and synthesize conclusions.
Proficient knowledge of clinical development process, regulatory requirements and ICH/GCP guidelines.
Who are Alterome Employees?
Although we share varied backgrounds and come with expertise in different areas, we aim to inspire hope for those affected by cancer. Our vision unites us to develop unique therapies that transform the lives of cancer patients, one alteration at a time. Thus, we seek the best people to join this special movement and invest the resources they need to grow, develop, and accomplish our collective goals. We have a passion for what we do and truly enjoy working with each other. In fact, many of us have worked together in multiple companies and there is a genuine camaraderie amongst the group. We would love to bring new faces to the group, and that’s where you come in!
Alterome Offers:
We provide our employees with medical, dental, and vision coverage, life insurance, a 401k w/company matching, competitive compensation (including equity), paid holidays, flexible time off, home office set up, full-service gym on-site (with showers and towel service!), professional development opportunities, phenomenal company culture, and more! Our office is centrally located in San Diego, CA at the intersection of the 15 and 56 Freeways. This is a hybrid role with three days per week in the office required - out of state candidates will not be considered at this time.
Salary Range:
$198,000 - $242,000/year based on skills and experience.
EEOC Statement:
Alterome Therapeutics, Inc. is an equal opportunity employer committed to building a diverse and inclusive organization. We measure each applicant, candidate, and employee based on their qualifications for the role, regardless of age, sex, religion, sexual orientation, gender identity, national origin, Veteran status, disability, and/or any other protected class characteristics. Furthermore, Alterome is committed to achieving all business objectives in compliance with all federal, state, and local laws.
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Alterome Therapeutics, Inc. was formed in December 2021 and officially launched operations in January 2022. We are a precision oncology biotech developing alteration-specific therapeutics to address high-value and validated oncogenic drivers. The company is led by a team of experienced leaders with a history of developing marketed oncology small molecule drugs. Alterome recently secured $132 million in Series B funding.
Job Summary:
We are seeking an Associate Director/Director, Clinical Scientist to join our Oncology Clinical Development team. The Associate Director/Director, Clinical Scientist will contribute to the development, planning and execution of one or more clinical studies and ensure scientific integrity and interpretation of study data of the clinical program(s). In this position, you will have the opportunity to develop your leadership, technical and critical thinking skills, and scientific acumen as a part of a cross-functional team. The Associate Director/Director, Clinical Scientist will report to and collaborate closely with the Senior Medical Director.
How You’ll Contribute to the Team:
Provide scientific guidance and support to the team, working in close collaboration with the study medical monitor.
Responsible for overseeing multiple studies and for various aspects of clinical study execution including protocol writing, building study infrastructure, staff training, data cleaning/analysis, investigator interaction and support of regulatory filings.
Integrates scientific knowledge and operational expertise to ensure translation of clinical research plans into efficiently delivered high quality studies.
Maintains proficient understanding of therapeutic disease area(s) and drug candidate, including underlying disease biology, therapeutic standard practice, compound(s) including mechanism of action and drug landscape.
Possesses proficient scientific expertise to propose, design and execute clinical studies for early and/or late-stage assets.
Coordinates with cross-functional teams to produce the final protocol, informed consent documents, and other clinical documents.
Contributes significantly to the development of CRFs, edit checks, and data trend analysis.
Leads and performs clinical/medical data review, including ongoing data cleaning (e.g., data review, query generation, protocol deviation review, SAE reconciliation, patient profile design and review).
Leads and prepares information for external/stakeholder meetings (e.g., Phase 1 Investigator meetings, Safety Review Committees, Governance, DMCs, Regulatory Authority) as directed by the medical monitor; Presents data and information to external investigators (e.g., SIV, Investigator Meetings) and internal stakeholders.
Researches and summarizes scientific information available in published literature for continual self-learning and to prepare training, study manual, and/or investigator meeting materials.
Contributes to statistical analysis plans, table, listing, figure design and the preparation of manuscripts and other presentations of study data.
Addresses site questions regarding protocol and related scientific issues.
Assists in writing or reviewing briefing books, health authority requests for information, IND annual reports, Investigator Brochures, and other regulatory documents.
Supports priorities within the functional area and contributes to or leads department initiatives as requested.
Performs additional duties as assigned.
Required Qualifications:
Bachelor’s Degree; Advanced degree or equivalent education/degree in life science/healthcare (e.g., PhD/PharmD/MSc) is preferred.
≥ 8 years of pharmaceutical clinical drug development experience, other levels considered depending on experience.
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.
Solid communication, technical writing and presentation skills.
Analytical skills with the ability to interpret clinical trial data and synthesize conclusions.
Proficient knowledge of clinical development process, regulatory requirements and ICH/GCP guidelines.
Who are Alterome Employees?
Although we share varied backgrounds and come with expertise in different areas, we aim to inspire hope for those affected by cancer. Our vision unites us to develop unique therapies that transform the lives of cancer patients, one alteration at a time. Thus, we seek the best people to join this special movement and invest the resources they need to grow, develop, and accomplish our collective goals. We have a passion for what we do and truly enjoy working with each other. In fact, many of us have worked together in multiple companies and there is a genuine camaraderie amongst the group. We would love to bring new faces to the group, and that’s where you come in!
Alterome Offers:
We provide our employees with medical, dental, and vision coverage, life insurance, a 401k w/company matching, competitive compensation (including equity), paid holidays, flexible time off, home office set up, full-service gym on-site (with showers and towel service!), professional development opportunities, phenomenal company culture, and more! Our office is centrally located in San Diego, CA at the intersection of the 15 and 56 Freeways. This is a hybrid role with three days per week in the office required - out of state candidates will not be considered at this time.
Salary Range:
$198,000 - $242,000/year based on skills and experience.
EEOC Statement:
Alterome Therapeutics, Inc. is an equal opportunity employer committed to building a diverse and inclusive organization. We measure each applicant, candidate, and employee based on their qualifications for the role, regardless of age, sex, religion, sexual orientation, gender identity, national origin, Veteran status, disability, and/or any other protected class characteristics. Furthermore, Alterome is committed to achieving all business objectives in compliance with all federal, state, and local laws.
#J-18808-Ljbffr