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Associate Director, GCP Quality Assurance

Company: Olema Pharmaceuticals
Location: Boston
Posted on: June 26, 2022

Job 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:

We are looking for a driven Associate Director, GCP Quality Assurance. You will collaborate with cross functional teams on deliverables.

This is a fantastic opportunity for a hands-on Associate Director to join a company with an industry leading Board of Directors and Management team and roll up their sleeves to build an innovative women's oncology company with significant potential to transform breast cancer treatments.

This position is available in either our San Francisco or Boston office.

What You Will Do:

* Provide GCP and compliance related advice to Internal Clinical Study teams
* Identify and prioritize audit strategies for GCP programs
* Coordinate and/or plan and conduct clinical study related audits (e.g., Investigator Sites, Clinical Service Providers, Internal Systems)
* Report audit findings to management with recommendations for resolution and verify appropriate corrective actions have been implemented and documented.
* Conduct training for staff (e.g., GCP, Inspection Readiness training)
* Interview, select, and train employees
* Prepare and host regulatory inspections
* Write and review Standard Operating Procedure (SOPs)
* Other duties as described

What You Will Bring:

* BS/BA degree in a scientific discipline with 8-12 years' work experience (or an equivalent combination of education and work experience) in FDA and ICH regulated clinical research in GCP QA
* In-depth knowledge of and ability to interpret and apply GCP, EU, FDA, and ICH regulations and guidelines
* The technical ability to critically analyze and communicate compliance related information and present associated risks
* Ability to coordinate internal and contract auditors and conduct audits
* Experience auditing Investigator sites, Clinical Service Providers, and Internal Systems Audits
* Experience with regulatory inspection and inspection readiness
* Experience with Quality Management Systems
* Experience reviewing study related documentation (e.g., protocols, clinical study reports, informed consents) and communicate findings to appropriate team members
* Ability to work independently, manage multiple priorities, and execute on goals
* Excellent interpersonal and written communication skills
* Must be able to travel domestically and internationally up to 25%
* Previous formal leadership experience preferred

Personal Characteristics:

Given the "small biotech" nature of the Company, cultural fit of the successful candidate is an important criterion for their 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
* Analytical thinking with problem-solving skills and the ability to adapt to changing priorities and deadlines
* 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 work streams 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

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.

Keywords: Olema Pharmaceuticals, Boston , Associate Director, GCP Quality Assurance, Executive , Boston, Massachusetts

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