Description
Olema Oncology (NASDAQ: 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), is in development to treat estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer. Olema recently initiated a Phase 1/2 dose-escalation and expansion clinical trial of OP-1250. We are supported in our mission by experienced and accomplished scientists and board members, leading healthcare investors, and some of the most innovative pharma companies. For more information about the company please visit
The Role: Olema Oncology is recruiting a Executive Director, Clinical Science, to join our team reporting to the Chief Medical Officer ("CMO"). The person in this role will contribute to the strategic and tactical planning, building, and developing the Clinical Science organization. Partnering with the CMO, you will drive towards achievement of Olema strategic clinical development goals.
As a key member of the Olema clinical leadership team, a significant part of your job will involve collaboration on the conduct, reporting, and analysis of the clinical studies. You will also interact with global Health Authorities, as well as our partner contract research organizations (CRO).
To be successful in this role you will have both strategic and tactical acumen, prior experience in the development of protocols, analysis of clinical trial data, literature searches, and data summaries. You will collaborate with the Clinical Development team in the overall conduct and timely execution of clinical trials, and work in collaboration with other key internal and external stakeholders in the development of the clinical program strategy and other activities towards achieving corporate objectives.
This position is available in either our San Francisco or Boston office.
What You Will Do: - Accountability for development, implementation, and execution of clinical development plans and clinical protocols. Establish and support strategy and shape protocols for ongoing development and eventual commercialization of products currently in early phase research
- Oversee writing of technical and clinical documents including protocols, amendments, investigator's brochures, and the clinical sections of regulatory documents
- Lead the clinical science team and collaborate with pharmacovigilance to identify and track any potential safety events within a given trial
- Organize and perform 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
- Communicate scientific data through visual presentations
- Support publication planning
- Provide company's senior management with regular status reports and updates on progress of clinical research and associated milestones
- Support business development activities
- Provide guidance to the project team on clinical development timelines
- Develop and nurture key working relationships with internal partners as well as external investigators, research organizations
- Continue to build and resource the Clinical Science team, mentor, and develop junior members of the team
- Establish best practices, identify the need, and drive the creation of functional standard operating procedures
- Work as part of a cross functional team to achieve corporate objectivities
What You Will Bring:
- Advanced degree such as a PhD or PharmD; equivalent combination of relevant education and experience may also be considered
- 10+ years preferred of relevant pharma/biotech industry experience
- Demonstrated leadership experience within a clinical development organization, including management of direct reports;
- Outstanding written communication skills with the ability to understand technical content such as complex regulatory documents, biologic rationale and information related to the drug development process
- Experience working with the principles and techniques of data analysis and interpretation
- Excellent external networking, relationship, and presentation skills and a strong presence
- Team-builder who leads by example, employs expertise and influence to encourage collaboration across departments, levels, and groups to achieve key objectives
- Strong computer skills
- Outstanding attention to detail
- Business acumen
- Strong interpersonal, verbal communication
- Excellent teamwork skills with the ability to complete deliverables by working effectively with Colleagues
- Demonstrated understanding of Phase I-III drug development preferred
- Working knowledge of the medical aspects of GCP, ICH, FDA and other relevant guidelines and regulations preferred
Additional Information: We require all employees to be fully vaccinated against COVID-19, subject to approved medical or religious exemptions or disability accommodations. We 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 provide equal opportunity to all employees and applicants for employment. Olema offers competitive compensation and benefits. We seek to provide an open, flexible, and friendly work environment to empower people and to provide them with a platform to develop their long-term careers. Please note: Olema does not accept agency resumes and we are not responsible for any fees related to unsolicited resumes. Thank you.
