Associate Director, GCP Quality Assurance
Company: Olema Pharmaceuticals
Location: Boston
Posted on: June 26, 2022
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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 www.olema.com
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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