About the Role >>> Director, Clinical ScienceAs the Director, Clinical Sciencereporting to the Vice President, 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
- Evaluate the safety, pharmacology, and efficacy of ongoing studies in close collaboration with the medical monitor and the safety, pharmacology and clinical operations teams
- 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 the Medical Monitor on review of enrollment packets, clinical development plans and scientific presentations
- 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 >>> 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 is required
- Experience in oncology clinical development is required
- 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
Experience:
- A minimum of 8 years' experience in biotech/pharmaceutical industry is required
- Strong knowledge of Good Clinical Practices (GCP), FDA, and EMEA/CHMP regulations and guidelines; familiarity with other international regulatory requirements is a plus
- 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
- Ability to interact effectively within a cross functional team
- 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
$220,000 - $245,000 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.
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