Director, Clinical Science

About the role

As the Director, Clinical Science reporting 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.

Responsibilities

• 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

Requirements

• A minimum of 8 years’ experience in biotech/pharmaceutical industry
• 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
• Advanced degree such as a PhD or PharmD 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

Qualifications

• 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

Skills

• Expertise in oncology clinical development
• Strong knowledge of GCP, FDA, and EMEA/CHMP regulations and guidelines
• Proactive problem-solving skills
• Effective cross-functional collaboration
• Strong communication and interpersonal skills
• Passion for drug development
• Self-motivation and ability to thrive in a fast-paced environment

Benefits

We provide 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.

Pay

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.

Schedule

The role is based out of our San Francisco, CA or Cambridge, MA office and will require up to 20% travel.

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.

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 olema.com; 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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