Director, Clinical Science

Olema Oncology; Boston (MA); On-site; USD 220,000 - 245,000; Full time

Benefits offered by this job

Competitive compensation

Flexible work environment

Benefits package

Job summary

Olema Oncology in Boston is seeking a Director of Clinical Science to lead clinical studies and enhance oncology outcomes. You will work in a multi-disciplinary team to ensure the successful execution of clinical trials and contribute to new cancer therapies.

The ideal candidate should have a PhD or PharmD, with at least 8 years of experience in oncology. Key responsibilities include writing clinical documents and evaluating clinical trial safety and efficacy. A competitive salary and benefits are offered.

Qualifications

• Advanced degree such as a PhD or PharmD is required.
• Experience in oncology clinical development is required.
• Strong knowledge of Good Clinical Practices (GCP) and regulatory guidelines.

Responsibilities

• Write technical and clinical documents including protocols and regulatory documents.
• Collaborate with study teams to track safety events.
• Evaluate the safety and efficacy of ongoing studies.

Skills

Attention to detail

Effective communication

Team collaboration

Problem-solving

Passion for drug development

Education

PhD or PharmD

Tools

Clinical trial protocols

Regulatory documents

Job description

Olema Oncology is a clinical-stage biopharmaceutical company committed to transforming the standard of care and improving outcomes for patients living with breast cancer and beyond. It’s an exciting time to be part of Team Olema , with our transfor mation into a fully integrated oncology company well underway , t op-line data from our lead program expected later this year , and our first potential commercial launch on the horizon.

Our leadproduct candidate, palazestrant, isa novel, orallyavailablecomplete estrogen receptor antagonist (CERAN)and selective estrogen receptor degrader (SERD)currently intwopivotalPhase 3clinicaltrials. We expect top-line data from OPERA-01,ourongoingPhase 3 trial of palazestrantas a monotherapy in patients withsecond- or third-lineER+/HER2-metastatic breast cancer (MBC), in the fall which, if successful, could lead to our first potential approval and commercial launchin 2027. OPERA-02,ourPhase 3 trial of palazestrantin combination with ribociblibin patients with frontlineER+/HER2- MBC, isenrolling patients. Togetherwith its mechanism of action, pharmacokinetic properties,andthe potential todemonstrateactivity in both ESR1wild-type and mutant tumors, palazestranthas the potential totransform the metastatic breast cancer treatment paradigm andaccess a$15 billionglobal market opportunity.

Aspiring to transform the metastatic treatment paradigm is an ambitious endeavor that requires a resolute approach to developing better therapies and a passionate team dedicated to helping the patients we serve feel better, longer. We possess a deep commitment to our shared purpose, the sustained pursuit of excellence, cultivating the courage required to advance our programs, drive to succeed, and a collective capacity for adaptability through learning, growth, and evolution. Team Olema is made up of nimble self-starters who bring consistency in their quest for the extraordinary every single day.

If you’re ready to be part of a tenacious, courageous, agile, and growing team, join us in making a profound impact, together – for our patients, for your career, and for what’s beyond.

About the Role – Director, Clinical Science

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.

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.

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.