Director, Regulatory Affairs Operations
Company: Olema Oncology
Location: Boston
Posted on: May 6, 2024
Job Description:
Who We Are > > > Why You Should Work With UsOlema
Oncology is a clinical-stage biopharmaceutical company focused on
the discovery, development and commercialization of targeted
therapies for women's cancers. Olema's lead product candidate,
palazestrant (OP-1250), is a proprietary, orally-available small
molecule with dual activity as both a complete estrogen receptor
(ER) antagonist (CERAN) and a selective ER degrader (SERD). It is
currently being evaluated both as a single agent in an ongoing
Phase 3 clinical trial, and in combination with CDK4/6 inhibitors
(palbociclib and ribociclib) and a PI3Ka inhibitor (alpelisib), in
patients with recurrent, locally advanced or metastatic ER-positive
(ER+), human epidermal growth factor receptor 2-negative (HER2-)
breast cancer. Palazestrant has been granted FDA Fast Track
designation for the treatment of ER+/HER2- metastatic breast cancer
that has progressed following one or more lines of endocrine
therapy with at least one line given in combination with a CDK4/6
inhibitor. Olema is headquartered in San Francisco and has
operations in Cambridge, Massachusetts. For more information,
please visit us at www.olema.com , or follow us on -Twitter -and
-LinkedIn .Onto something big, together. Olema is made up of people
who are passionate beyond measure. Each and every day, we come
together to do amazing things - for each other, for science, and
for women with cancer. -Our -modern hybrid workplace model
-encourages employees to split their week between working from home
and at our lab/office, while also providing several allowances to
help with both home office and commute expenses. -While at the
lab/office, our teams -build their -camaraderie, opening the door
for more authentic mentorship and career development opportunities.
While at home, employees can -make the most of their time --
whether that's picking up the kids from school, going on a mid-day
run, or catching up on chores. Through this model, we strive to
offer our employees -the best of both work models. About the Role
> > > Director, Regulatory Affairs Operations - As the
Director of Regulatory Affairs Operations, reporting to the Vice
President of Regulatory Affairs and Quality Assurance, you will
develop and lead global regulatory operations to support the
advancement of multiple clinical trials. This role provides
leadership in the operational guidance and execution of regulatory
concepts within cross - functional project teams and supports
interactions with global health authorities and corporate partners
with regulatory deliverables. -This role is based out of our
Cambridge, MA office and may require 15% travel. -Your work will
primarily encompass: -
- Serve as the Regulatory Operations Lead on project submission
planning and submission processes, while proactively managing
critical operational issues, and ensuring timely submission. -
- Provide regulatory operations expertise and leadership to cross
functional teams supporting Olema's pipeline (Review clinical
protocols, informed consent forms, Investigator's Brochures, CMC,
site documentation etc. for regulatory compliance). -
- Oversee and prepare documentation to support global regulatory
filings to ensure accuracy, applicability, consistency, and control
of regulatory documents. Interact with SMEs for accuracy of
content.
- Assist the Global Regulatory Lead in meetings for response to
Heath Authority requests, content verification and follow-ups with
functional leads.
- Coordinate and prepare responses to Requests for Information
from health authorities.
- Provide regulatory eCTD submission support to INDs, CTAs,
IMPDs. NDAs, JNDA/BLAs and other regulatory submissions. -
- Conduct operational risk assessments and develop robust
mitigation measures. -
- Maintain and track all regulatory submissions to Health
Authorities and the Health Authority correspondences. -
- Identify, implement, and administrate enterprise document
management systems and publishing tools such as: file transfer,
tracking and archival.
- Provide expert support and guidance on Regulatory Information
Management to the teams.
- Advise and train on acceptable eCTD and document publishing
formats to ensure compliance globally across industry
standards.
- Perform quality assurance of submission documents and published
output to ensure compliance with global eCTD requirements.
- Assist with development and implementation of regulatory
processes related to submission standards, working practices and
quality controls.
- Monitor changes in regulations and keep project teams and
management informed of such changes.
- Maintain expertise with current and future global regulatory
submission standards and their implementation within Olema.
- Build strong partnerships with functions and key stakeholders
within Olema, and share knowledge and expertise with teams.
- Assist the Head of Regulatory Affairs and Quality Assurance in
Departmental Operations and vendor management.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: -
- BS or MS in a relevant discipline is required. -
- Knowledge and experience of eCTD submissions. -
- Knowledge and experience with enterprise document management
systems (eDMS), preferably Veeva regulatory information
management.
- Knowledge of U.S. and international regulations including cGMP,
GCP, GPV, GLP, ICH guidance documents.
- Knowledge and understanding of global industry standards,
guidelines, and validation concepts, including eCTD format and
registration tracking. -Experience: -
- Minimum 10 years pharmaceutical industry experience in
Regulatory Affairs.
- People management experience is preferred. -
- Demonstrated leadership skills while working in a fast paced
and changing environment. -
- Experience in build and submission of NDA/BLA and life-cycle
management is highly desirable. Attributes: -
- Displays strong proactive acumen and inclusive way of
engagement to drive decision making, turnaround time improvement
and effective ways of working.
- Influences the cross-functional team to adapt fit-for purpose
solutions to meet the expected timelines.
- Ability to understand, analyze and develop recommendations from
multiple complex sources such as scientific and operational
perspectives. -
- Excellent written and verbal communication skills.
- Excellent negotiation and organizational skills.The base pay
range for this position is expected to be $225,000 - $235,000
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. -#LI-CK1We 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.Olema also
requires all employees to be fully vaccinated against COVID-19,
subject to approved medical or religious exemptions or disability
accommodations. The health and safety of our employees is important
to us!Please note: Olema doesn't accept agency resumes and is not
responsible for any fees related to unsolicited resumes. Thank you.
Additional Note/Fraud Alert : Olema will not conduct interviews via
text message or messaging platforms and will not ask you to
download anything as part of your interview. Though we use third
party tools to help with advertising our jobs, please be vigilant
in checking that the communication is in fact coming from
Olema.
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Keywords: Olema Oncology, Leominster , Director, Regulatory Affairs Operations, Executive , Boston, Massachusetts
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