Associate / Director, Clinical Science
Job DetailsWho We Are >>> Why You Should Work With Us Olema Oncology (OLMA) is a biopharmaceutical company developing innovative targeted therapies for women's cancers.
Our lead program, OP-1250, a potential best-in-class complete estrogen receptor antagonist (CERAN) / selective estrogen receptor degrader (SERD), is in Phase 2 clinical development for the treatment of ER+/HER2- Breast Cancer.
Our goal is to transform the standard of care for women living with cancer by developing more convenient and effective therapies.
Onto something big, together.
Olema is made up of people who are passionate beyond measure.
Each and every day, we come together to do amazing things - for each other, for science, and for women with cancer.
Strategically located in two large biotech hubs - San Francisco, CA and Cambridge, MA - we offer a flexible work environment andthe best of both coasts.
Our modern hybrid workplace model encourages employees to split their week between working from home and at our lab/office, while also providing several allowances to help with both home office and commute expenses.
While at the lab/office, our teams build their camaraderie, opening the door for more authentic mentorship and career development opportunities.
While at home, employees can make the most of their time - whether that's picking up the kids from school, going on a mid-day run, or catching up on chores.
Through this model, we strive to offer our employeesthe best of both work models.
About the Role >>> Associate / Director Clinical Science As the Associate / Director, Clinical Science reporting to the Executive Director, Clinical Science, you will play a key role in one of our ongoing clinical studies.
You will work collaboratively in a multi-disciplinary team setting including Clinical Operations, Medical Monitors, Data Management, Biostatistics, Clinical Pharmacology, Regulatory and Program Management, in the planning, conduct and analysis of clinical trials.
Your job contributes to and supports Olema's mission of developing therapies that offer the potential to improve outcomes for women living with cancer.
This role is based out of our San Francisco, CA or Cambridge, MA office and will require up to 20%travel.
Your work will primarily encompass:
Writing of technical and clinical documents including protocols, amendments, investigator's brochures, and the clinical sections of regulatory documents Working with the study team to identify and track any potential safety events within a given trial Interacting with investigators and thought leaders in oncology to facilitate the design of clinical synopses and protocols Organizing and performing the study level and individual subject level analysis of the clinical trial data to gain insights and develop strategies for the clinical study report (CSR) writing Contributing to the writing and/or review product specific abstracts, publications and supporting the development of presentations for scientific meetings Maintaining clinical and technical expertise in the therapeutic area of oncology Attending scientific meetings pertinent to clinical science activities And will also include:
Collaborating with Clinical Operations and other internal study teams to develop Informed Consent Forms, Case Report Forms and CRF instructions Participating in ongoing clinical data review in collaboration with a cross functional team Collaborating with Clinical Operations and other team members in the development of agendas, training materials and presentation for site visits, investigator meetings and other study related activities Ensuring adherence to Olema's Standard Operation Procedures and values, and maintaining the highest level of ethical behavior by leading by example Ideal Candidate Profile >>> Self-Motivated Clinical Scientist A love of challenging, important work.
We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives.
All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture.
As such, we are looking for someone with the right combination of knowledge , experience , and attributes for this role.
Knowledge:
Advanced degree such as a PhD or PharmD or equivalent combination of relevant education and experience may also be considered Experience in oncology clinical development Ability to interact effectively within a cross functional team
Experience:
6
years' experience in biotech/pharmaceutical industry Comprehensive knowledge of oncology clinical trial implementation and drug development process Demonstrated understanding of the clinical drug development process to execute drug development strategic plans and meet milestones Strong knowledge of Good Clinical Practices (GCP), FDA, and EMEA/CHMP regulations and guidelines; familiarity with other international regulatory requirements is aplus Proactively identifying challenges/problems and proposing solutions with a strong sense of urgency Demonstrated success motivating both internal and external team members and collaborators, fostering and nurturing teamwork Attributes:
Strong attention to detail Excellent written and oral communication skills Ability to work in a diverse and dynamic cross-functional team Passionate about the drug-development process Self-starter who thrives in a fast-paced environment The base pay range for this position is expected to be$165,000 - $200,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience.
The total compensation package for this position also includes equity, bonus, and benefits.
#LI-CK1 Important Information >>> We provide equal opportunity to all employees and applicants for employment and believe that great ideas and discoveries come from a mix of expertise, background, and experience.
Olema is building a culture where the value of difference is celebrated.
We offer a competitive compensation and benefits package, seeking to provide an open, flexible, and friendly work environment to empower employees and provide them with a platform to develop their long-term careers.
A Summary of Benefits is available for all applicants.
Olema also requires all employees to be fully vaccinated against COVID-19, subject to approved medical or religious exemptions or disability accommodations.
The health and safety of our employees is important to us! Please note:
Olema doesn't accept agency resumes and is not responsible for any fees related to unsolicited resumes.
Thank you.
Additional Note/Fraud Alert:
Olema will not conduct interviews via text message or messaging platforms and will not ask you to download anything as part of your interview.
Though we use third party tools to help with advertising our jobs, please be vigilant in checking that the communication is in fact coming from Olema.
Recommended Skills Agenda Development Attention To Detail Biostatistics Biotechnology Case Report Forms Clinical Development Estimated Salary: $20 to $28 per hour based on qualifications.
Our lead program, OP-1250, a potential best-in-class complete estrogen receptor antagonist (CERAN) / selective estrogen receptor degrader (SERD), is in Phase 2 clinical development for the treatment of ER+/HER2- Breast Cancer.
Our goal is to transform the standard of care for women living with cancer by developing more convenient and effective therapies.
Onto something big, together.
Olema is made up of people who are passionate beyond measure.
Each and every day, we come together to do amazing things - for each other, for science, and for women with cancer.
Strategically located in two large biotech hubs - San Francisco, CA and Cambridge, MA - we offer a flexible work environment andthe best of both coasts.
Our modern hybrid workplace model encourages employees to split their week between working from home and at our lab/office, while also providing several allowances to help with both home office and commute expenses.
While at the lab/office, our teams build their camaraderie, opening the door for more authentic mentorship and career development opportunities.
While at home, employees can make the most of their time - whether that's picking up the kids from school, going on a mid-day run, or catching up on chores.
Through this model, we strive to offer our employeesthe best of both work models.
About the Role >>> Associate / Director Clinical Science As the Associate / Director, Clinical Science reporting to the Executive Director, Clinical Science, you will play a key role in one of our ongoing clinical studies.
You will work collaboratively in a multi-disciplinary team setting including Clinical Operations, Medical Monitors, Data Management, Biostatistics, Clinical Pharmacology, Regulatory and Program Management, in the planning, conduct and analysis of clinical trials.
Your job contributes to and supports Olema's mission of developing therapies that offer the potential to improve outcomes for women living with cancer.
This role is based out of our San Francisco, CA or Cambridge, MA office and will require up to 20%travel.
Your work will primarily encompass:
Writing of technical and clinical documents including protocols, amendments, investigator's brochures, and the clinical sections of regulatory documents Working with the study team to identify and track any potential safety events within a given trial Interacting with investigators and thought leaders in oncology to facilitate the design of clinical synopses and protocols Organizing and performing the study level and individual subject level analysis of the clinical trial data to gain insights and develop strategies for the clinical study report (CSR) writing Contributing to the writing and/or review product specific abstracts, publications and supporting the development of presentations for scientific meetings Maintaining clinical and technical expertise in the therapeutic area of oncology Attending scientific meetings pertinent to clinical science activities And will also include:
Collaborating with Clinical Operations and other internal study teams to develop Informed Consent Forms, Case Report Forms and CRF instructions Participating in ongoing clinical data review in collaboration with a cross functional team Collaborating with Clinical Operations and other team members in the development of agendas, training materials and presentation for site visits, investigator meetings and other study related activities Ensuring adherence to Olema's Standard Operation Procedures and values, and maintaining the highest level of ethical behavior by leading by example Ideal Candidate Profile >>> Self-Motivated Clinical Scientist A love of challenging, important work.
We are a pragmatic team, driven to imagine and develop meaningful therapies for improving lives.
All employees within our company play a unique and crucial role in our success, both in accomplishing our mission and building a positive company culture.
As such, we are looking for someone with the right combination of knowledge , experience , and attributes for this role.
Knowledge:
Advanced degree such as a PhD or PharmD or equivalent combination of relevant education and experience may also be considered Experience in oncology clinical development Ability to interact effectively within a cross functional team
Experience:
6
years' experience in biotech/pharmaceutical industry Comprehensive knowledge of oncology clinical trial implementation and drug development process Demonstrated understanding of the clinical drug development process to execute drug development strategic plans and meet milestones Strong knowledge of Good Clinical Practices (GCP), FDA, and EMEA/CHMP regulations and guidelines; familiarity with other international regulatory requirements is aplus Proactively identifying challenges/problems and proposing solutions with a strong sense of urgency Demonstrated success motivating both internal and external team members and collaborators, fostering and nurturing teamwork Attributes:
Strong attention to detail Excellent written and oral communication skills Ability to work in a diverse and dynamic cross-functional team Passionate about the drug-development process Self-starter who thrives in a fast-paced environment The base pay range for this position is expected to be$165,000 - $200,000 annually, however the base pay offered may vary depending on location, market, job related knowledge, skills and capabilities, and experience.
The total compensation package for this position also includes equity, bonus, and benefits.
#LI-CK1 Important Information >>> We provide equal opportunity to all employees and applicants for employment and believe that great ideas and discoveries come from a mix of expertise, background, and experience.
Olema is building a culture where the value of difference is celebrated.
We offer a competitive compensation and benefits package, seeking to provide an open, flexible, and friendly work environment to empower employees and provide them with a platform to develop their long-term careers.
A Summary of Benefits is available for all applicants.
Olema also requires all employees to be fully vaccinated against COVID-19, subject to approved medical or religious exemptions or disability accommodations.
The health and safety of our employees is important to us! Please note:
Olema doesn't accept agency resumes and is not responsible for any fees related to unsolicited resumes.
Thank you.
Additional Note/Fraud Alert:
Olema will not conduct interviews via text message or messaging platforms and will not ask you to download anything as part of your interview.
Though we use third party tools to help with advertising our jobs, please be vigilant in checking that the communication is in fact coming from Olema.
Recommended Skills Agenda Development Attention To Detail Biostatistics Biotechnology Case Report Forms Clinical Development Estimated Salary: $20 to $28 per hour based on qualifications.
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