Vice President, Clinical Operations
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 www.olema.comThe Role:
We are looking for a highly motivated and experienced leader for the role of Vice President of Clinical Operations, reporting directly to the Chief Medical Officer. In this role you will spearhead the clinical operations activities across all clinical studies for our clinical development program. Activities include leading clinical teams and operations, planning projects/trials, budgeting and financial oversight, managing staff and CROs, meeting timelines and ensuring GCP compliance.
You are also a results-oriented, roll-up the sleeves person who leads by example and are committed to nurturing a positive and productive work environment that will attract and retain highly qualified clinical operations professionals. You are dedicated to assisting in the development of staff and infrastructure and ensuring proper resource allocation across programs/trials.
This position is available in either our San Francisco or Boston office.
Spearhead and Champion Clinical Operations
- Oversee and manage all operations and staff involved in clinical operations, data management and other groups as assigned.
- Ensure that clinical trials are properly resourced, managed, executed and inspection ready in accordance with timelines, good quality practices and applicable regulatory requirements.
- Apply your expertise to develop a life-cycle strategy and evaluation of new programs to be prioritized or advanced into clinical development.
- Participate in the review, planning and implementation of clinical trials. Evaluate hypotheses, objectives, study design, feasibility and regulatory requirements, and identify medical and logistical problems that may impede the study.
- Develop clinical timelines, budget forecasts, and ensure accountability for tracking and deliverables.
- Oversee global CROs and vendors from identification and selection to close of contracts.
- Collaborate with others on the development of protocols, annual safety reports, clinical study reports, publications, presentations and regulatory submissions.
- Review relevant master service agreements, statements of work and quality agreements.
- Regularly present clinical operations updates and strategy to Olema’s executive committee
Evolve the Clinical Operations Department Infrastructure
- Lead initiatives to build the clinical operations department infrastructure.
- Plan clinical operations headcount and hiring needs to meet program workload demands.
- Represent and advocate for clinical operations needs and resources at the Executive Committee level.
Mentor Your Team and Develop Their Talents
- Lead the members of the clinical operations team by example.
- Implement best practices and standards for trial management in collaboration with other members of the clinical operations team, including establishment of SOPs.
- Provide leadership, mentorship and development opportunities to others within Olema.
- Minimum of 15 years clinical operations experience in the pharmaceutical/biotech industry, with at least 8 years direct line management experience.
- BS/MS in a scientific discipline or equivalent experience.
- Experience in and understanding of end-to-end management of clinical trial conduct, the pharmaceutical industry, clinical drug development, clinical trials operations and regulatory components is essential. A thorough understanding of drug development from IND to NDA.
- Proven success in leading and coordinating cross-functional clinical operations teams. (e.g., clinical operations, data management, clinical supply chain).
- Experience working on complex studies involving biomarkers and activities across multiple vendors.
- Knowledge and experience with developing, negotiating and managing contracts (vendor and site).
- Experience in regulatory inspection.
- Experience in developing RFPs, selection of CROs/vendors, and management of external resources
- Demonstrated ability to manage international clinical trials within designated program budgets and timelines
- Proven success participating in cross-departmental clinical strategy, planning and implementation activities. (Departments include senior management, regulatory, QA, CMC, program management, finance, business development, medical affairs, clinical development and medical writing.)
- Strong working knowledge of FDA, EMA, PMDA regulations and expectations, Good Clinical Practice, ICH guidelines, and clinical operations best practices.
- Demonstrated independence, problem-solving abilities, self-motivation, resourcefulness and ability to work in a fast-paced team environment.
- Experience with building clinical operations infrastructure including writing of SOPs.
- Excellent communication skills with an ability to efficiently and productively communicate both orally and in writing. Experience presenting to the senior leadership team is a plus.
- Oncology experience is a plus.
Given the “small biotech” nature of the Company, cultural fit is an important criterion for success at Olema. Desired characteristics include a high level of curiosity, intelligence, ability to work independently, “can do” attitude, and ability to work cross-functionally. Strong initiative and follow through are essential for this job. Specific personal characteristics include:
- Excellent verbal and written communication and skills coupled with the ability to advocate for a position and engage in vigorous debate to reach the best decision.
- Proactive thinking, strong scientific and analytical skills, decisiveness and the ability to perform as a respected team member and leader.
- A commitment to excellence.
- Self-motivated and enthusiastic; fast learner who can identify the core project challenges and expeditiously change course as required in a fast-paced organization.
- Teamwork and collaboration; balances team and individual responsibilities; gives and welcomes feedback; puts success of team above own interests; supports everyone's efforts to succeed; shares expertise with others.
- Entrepreneurial mindset and the ability to prioritize key workstreams and requirements that will change over the near and mid-term.
- A demonstrated ability to make decisions on incomplete information and in areas where a high degree of professional judgment is required.
- Be a “difference maker” in terms of one’s professionalism and contributions.
- Have impeccable professional ethics, integrity and judgment.
- Be collegial, hard-working, confident, a self-starter and have a passion for results.