Olema Oncology
Associate Director, Clinical Science
Olema Oncology, San Francisco, California, United States, 94199
Olema Oncology is a cancer medicines company dedicated to impacting breast cancer and beyond. Our lead program, palazestrant (OP-1250), is a differentiated oral medicine known as a complete estrogen receptor antagonist (CERAN) initially in development for metastatic breast cancer. Our pipeline also includes OP-3136, a potent, selective oral inhibitor of the KAT6 pathway. At Olema, we are building a focused team committed to our mission with intention and clarity. Working alongside a talented passionate group of leaders and advisors, we strive to create better medicines that aim to help patients feel better, longer. For more information, visit us at www.olema.com.
About the Role >>> Associate Director, Clinical Science As the Associate Director, Clinical Science reporting to the Director, Clinical Science, you will play a key role in one of our ongoing clinical studies. You will collaborate within a multi-disciplinary team—including Clinical Operations, Medical Monitors, Data Management, Biostatistics, Clinical Pharmacology, Regulatory, and Program Management—to plan, conduct, and analyze 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 may be based out of our San Francisco, CA or Cambridge, MA office and will require up to 15% travel.
Your work will
primarily
encompass:
Assisting in writing clinical documents including protocols, amendments, investigator’s brochures, clinical study report (CSR), and the clinical sections of regulatory documents
Interacting with investigators and thought leaders in oncology to facilitate the design of clinical synopsis and protocols
Participating in ongoing clinical data review in collaboration with a cross functional team
Ensure trial implementation according to the protocol and analyze information to assess issues relating to protocol conduct and/or individual subject safety
Contributing to the writing and/or review product specific abstracts, publications and supporting the development of presentations for scientific meetings
And will also include:
Collaborating with Clinical Operations and other internal study teams to develop Informed Consent Forms, Case Report Forms and CRF instructions
Collaborating with Clinical Operations and other team members to develop agendas, training materials and presentations 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
Maintaining clinical and technical expertise in the therapeutic area of oncology
Attending scientific meetings pertinent to clinical science activities
Ideal Candidate Profile >>> Self-Motivated Clinical Scientist Knowledge:
Advanced degree such as a PhD or PharmD; equivalent combination of relevant education and experience may also be considered
Experience in oncology clinical development is required
Ability to interact effectively within a cross-functional team
Experience:
5-7+ years’ experience working as a clinical scientist in the 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 a plus
Ability to proactively identify challenges/problems and propose 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 $200,000 - $215,000 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.
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.
Fraud Alert: We are aware of employment scams where individuals pose as representatives of Olema Oncology and make false use of our company name to defraud job seekers. To protect yourself, please note that Olema’s official email addresses end in @olema.com. Our official corporate website is oleva/boilerplate; our careers page is olema.com/careers; our LinkedIn page is linkedin.com/company/olema-oncology. Please visit these links for official information from Olema. Communication from any other variant is fraudulent. Olema does not conduct interviews via text message/messaging platforms, will not ask you to download anything as part of your interview, will never request any form of payment, provide upfront payments of any kind, and does not make job offers without an in-person interview.
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About the Role >>> Associate Director, Clinical Science As the Associate Director, Clinical Science reporting to the Director, Clinical Science, you will play a key role in one of our ongoing clinical studies. You will collaborate within a multi-disciplinary team—including Clinical Operations, Medical Monitors, Data Management, Biostatistics, Clinical Pharmacology, Regulatory, and Program Management—to plan, conduct, and analyze 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 may be based out of our San Francisco, CA or Cambridge, MA office and will require up to 15% travel.
Your work will
primarily
encompass:
Assisting in writing clinical documents including protocols, amendments, investigator’s brochures, clinical study report (CSR), and the clinical sections of regulatory documents
Interacting with investigators and thought leaders in oncology to facilitate the design of clinical synopsis and protocols
Participating in ongoing clinical data review in collaboration with a cross functional team
Ensure trial implementation according to the protocol and analyze information to assess issues relating to protocol conduct and/or individual subject safety
Contributing to the writing and/or review product specific abstracts, publications and supporting the development of presentations for scientific meetings
And will also include:
Collaborating with Clinical Operations and other internal study teams to develop Informed Consent Forms, Case Report Forms and CRF instructions
Collaborating with Clinical Operations and other team members to develop agendas, training materials and presentations 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
Maintaining clinical and technical expertise in the therapeutic area of oncology
Attending scientific meetings pertinent to clinical science activities
Ideal Candidate Profile >>> Self-Motivated Clinical Scientist Knowledge:
Advanced degree such as a PhD or PharmD; equivalent combination of relevant education and experience may also be considered
Experience in oncology clinical development is required
Ability to interact effectively within a cross-functional team
Experience:
5-7+ years’ experience working as a clinical scientist in the 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 a plus
Ability to proactively identify challenges/problems and propose 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 $200,000 - $215,000 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.
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.
Fraud Alert: We are aware of employment scams where individuals pose as representatives of Olema Oncology and make false use of our company name to defraud job seekers. To protect yourself, please note that Olema’s official email addresses end in @olema.com. Our official corporate website is oleva/boilerplate; our careers page is olema.com/careers; our LinkedIn page is linkedin.com/company/olema-oncology. Please visit these links for official information from Olema. Communication from any other variant is fraudulent. Olema does not conduct interviews via text message/messaging platforms, will not ask you to download anything as part of your interview, will never request any form of payment, provide upfront payments of any kind, and does not make job offers without an in-person interview.
#J-18808-Ljbffr