Olema Oncology
Director, Clinical Operations
Olema Oncology, Boston, Massachusetts, us, 02298
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.
The Role:
We are looking for a strategic
Director of Clinical Operations
to lead the planning and execution of the operational strategy of Olema Oncology clinical trials. Reporting to the Sr. Director, Clinical Operations, this individual will be an experienced, strategic late phase oncology clinical operations leader responsible for project and trial planning, budgeting and financial oversight, staff and contract research organization (CRO) management, program/trial clinical operations, leading clinical study teams, timelines, GCP compliance and inspection readiness activities.
This is a fantastic opportunity for an experienced and capable leader to join a company with an industry leading Board of Directors and Management team, participate in defining operational strategy for Olema's studies and roll up their sleeves to build an innovative women's oncology company with significant potential to transform breast cancer treatments.
This is a highly visible role within the organization and requires working on site at either our
Cambridge
or
San Francisco
office at least two days a week in a hybrid model with the
ability to travel up to 15%
.
What You Will Do:
Provide strategic leadership and direction to study teams and is accountable in the planning and execution of clinical trials to meet timelines and quality deliverables in accordance with corporate study goalsOversee global harmonization of study processes and CRO/vendor activities, ensuring transparency and consistency across Clinical Trial Leads as well as the study execution teamIndependently manage and oversee budgets and timelines, reporting and justifying study metrics to product teams and executive management; participate in financial forecasting, accruals, and reconciliationsEstablish and/or implement best trial management practices, standards, systems and SOPs in collaboration with other members of the clinical operations and cross-functional teamsEnsure that clinical trials are conducted in compliance with the protocol and applicable regulatory requirements and oversee/drive/collaborate on inspection readiness activitiesContribute to the development of protocols, Investigator Brochures, DSURs, and clinical study reports; oversee the creation of project plans, study manuals, and trial toolsPresent Clinical Operations strategy and updates to Olema's program team(s), senior leadership and executive committeeSuccessfully establish strong relationships, working in partnership with key stakeholders across OlemaSeek alignment within the organization to maximize the delivery of outputs to achieve the overall clinical operations strategyBring a "can-do" attitude while being able to respectfully challenge partners and be assertive, when necessary, with project timelines, finances, and scope; stretch Clinical Operations and other clinical departments to deliver more, while also serving as a gatekeeper for new initiatives and studies when it comes to feasibility, regulatory issues, and prioritization within overall budget and resource constraintsDirectly lead, coach, and mentor Olema Clinical Operations staff: Ensure the recruitment and development of the right talent and Oncology therapeutic area expertise to enable the appropriate level of strategic input into clinical program design and clinical study design. Responsible for the growth and development of talentSeek to continually raise the bar for the operationalization of Olema oncology study teams, driving timeline and resource efficiency, and ensuring information is captured, retained and shared across functions to leverage in future workDevelop and implement strategic CRO and vendor selection and provides management and documented oversight; accountable for resolving vendor issues that need to be addressed at the executive levelWhat You Will Bring:
A minimum of 12 years of bio-pharmaceutical industry experience in a global pharma organization delivering medicines/therapies to a broad market across various therapeutic areas including at least 4 years' experience managing direct reportsBachelor's Degree or higher in a scientific discipline or previous experience working directly in a sponsor clinical research settingBroad knowledge and track record of successfully managing clinical trial operations through all stages of the drug development lifecycle. Knows what can go wrong and how to proactively prepare for all possible outcomesSuccessfully led a global phase 3 oncology clinical trialDirect experience in oncology clinical research across all stages of developmentExhibited experience in delivery of study enrollmentStrong experience managing multiple CROs/vendors to successful outcomesBig picture and strategic thinker: can formulate a vision of future state and lead the organization to build tactical plans to achieve thisExperience implementing large-scale change and process improvements relating to clinical trialsExperience with financial planning and resource managementExcellent collaborator: easily builds relationships and gains cross functional alignment. Experience with cross-functional leadership and a proven ability to influence and get things done within the intricacies of a matrixed organizationExcellent business and financial aptitude, very analytical and uses data to drive the business and continuous improvementsExperience leading teams and managing and developing talentProficient computer skills, specifically with Microsoft Office Suite that include Word, Excel, PowerPoint, and OutlookWorking knowledge of MS Project or Smartsheet for development and update of clinical study timelines
The base pay range for this position is expected to be
$220,000 - $230,000
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-MK1
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.
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.
The Role:
We are looking for a strategic
Director of Clinical Operations
to lead the planning and execution of the operational strategy of Olema Oncology clinical trials. Reporting to the Sr. Director, Clinical Operations, this individual will be an experienced, strategic late phase oncology clinical operations leader responsible for project and trial planning, budgeting and financial oversight, staff and contract research organization (CRO) management, program/trial clinical operations, leading clinical study teams, timelines, GCP compliance and inspection readiness activities.
This is a fantastic opportunity for an experienced and capable leader to join a company with an industry leading Board of Directors and Management team, participate in defining operational strategy for Olema's studies and roll up their sleeves to build an innovative women's oncology company with significant potential to transform breast cancer treatments.
This is a highly visible role within the organization and requires working on site at either our
Cambridge
or
San Francisco
office at least two days a week in a hybrid model with the
ability to travel up to 15%
.
What You Will Do:
Provide strategic leadership and direction to study teams and is accountable in the planning and execution of clinical trials to meet timelines and quality deliverables in accordance with corporate study goalsOversee global harmonization of study processes and CRO/vendor activities, ensuring transparency and consistency across Clinical Trial Leads as well as the study execution teamIndependently manage and oversee budgets and timelines, reporting and justifying study metrics to product teams and executive management; participate in financial forecasting, accruals, and reconciliationsEstablish and/or implement best trial management practices, standards, systems and SOPs in collaboration with other members of the clinical operations and cross-functional teamsEnsure that clinical trials are conducted in compliance with the protocol and applicable regulatory requirements and oversee/drive/collaborate on inspection readiness activitiesContribute to the development of protocols, Investigator Brochures, DSURs, and clinical study reports; oversee the creation of project plans, study manuals, and trial toolsPresent Clinical Operations strategy and updates to Olema's program team(s), senior leadership and executive committeeSuccessfully establish strong relationships, working in partnership with key stakeholders across OlemaSeek alignment within the organization to maximize the delivery of outputs to achieve the overall clinical operations strategyBring a "can-do" attitude while being able to respectfully challenge partners and be assertive, when necessary, with project timelines, finances, and scope; stretch Clinical Operations and other clinical departments to deliver more, while also serving as a gatekeeper for new initiatives and studies when it comes to feasibility, regulatory issues, and prioritization within overall budget and resource constraintsDirectly lead, coach, and mentor Olema Clinical Operations staff: Ensure the recruitment and development of the right talent and Oncology therapeutic area expertise to enable the appropriate level of strategic input into clinical program design and clinical study design. Responsible for the growth and development of talentSeek to continually raise the bar for the operationalization of Olema oncology study teams, driving timeline and resource efficiency, and ensuring information is captured, retained and shared across functions to leverage in future workDevelop and implement strategic CRO and vendor selection and provides management and documented oversight; accountable for resolving vendor issues that need to be addressed at the executive levelWhat You Will Bring:
A minimum of 12 years of bio-pharmaceutical industry experience in a global pharma organization delivering medicines/therapies to a broad market across various therapeutic areas including at least 4 years' experience managing direct reportsBachelor's Degree or higher in a scientific discipline or previous experience working directly in a sponsor clinical research settingBroad knowledge and track record of successfully managing clinical trial operations through all stages of the drug development lifecycle. Knows what can go wrong and how to proactively prepare for all possible outcomesSuccessfully led a global phase 3 oncology clinical trialDirect experience in oncology clinical research across all stages of developmentExhibited experience in delivery of study enrollmentStrong experience managing multiple CROs/vendors to successful outcomesBig picture and strategic thinker: can formulate a vision of future state and lead the organization to build tactical plans to achieve thisExperience implementing large-scale change and process improvements relating to clinical trialsExperience with financial planning and resource managementExcellent collaborator: easily builds relationships and gains cross functional alignment. Experience with cross-functional leadership and a proven ability to influence and get things done within the intricacies of a matrixed organizationExcellent business and financial aptitude, very analytical and uses data to drive the business and continuous improvementsExperience leading teams and managing and developing talentProficient computer skills, specifically with Microsoft Office Suite that include Word, Excel, PowerPoint, and OutlookWorking knowledge of MS Project or Smartsheet for development and update of clinical study timelines
The base pay range for this position is expected to be
$220,000 - $230,000
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-MK1
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.
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.