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Senior Director, Patient Safety Sciences

Employer
Olema Oncology
Location
San Francisco, California
Start date
Nov 22, 2023

View more

Discipline
Administration, Clinical, Manufacturing & Production
Required Education
Doctorate/PHD/MD
Position Type
Full time
Hotbed
Biotech Bay

Job Details

Who We Are >>> Why You Should Work With Us

Olema 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 2 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 >>> Senior Director, Patient Safety Sciences

As the first member of the Patient Safety Organization this Senior Director, Patient Safety Sciences will report to the Vice President, Clinical Development. You will lay a strong foundation for the Safety function and will serve as a safety expert accountable for the overseeing planning, implementation, and management of Patient Safety activities in support of Olema’s development portfolio. You will work effectively, with multiple other departments across the organization, and with external stakeholders such as Investigators and Regulatory Agencies.  

Your work will primarily encompass: 

  • The strategic planning and execution of Olema’s Patient Safety activities, including cross functional activities with other departments, recommend pharmacovigilance / risk management activities and lead signal detection and evaluation activities
  • Authoring of the safety sections of clinical and regulatory documents, including the drug risk-benefit, safety relevant section of protocols, IB, ICF, briefing books, drug safety core information and other internal or external documents.
  • Clinical/medical review of SAEs, SUSARs, Analysis of Similar Events for SUSARs, as required, including reviewing the source records, reviewing the case narrative for accuracy, reviewing MedDRA coding for appropriateness, identifying medically relevant queries, confirming event “expectedness” based upon the reference safety information, preparation of sponsor assessment, and assisting drug safety staff in determining reportability.
  • Contribution to Data Monitoring Committees meetings.
  • Contribution to quality systems, audits, inspection readiness and inspections.
  • Develop and conduct safety related training for the company and for the clinical sites

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 knowledgeexperience, and attributes for this role. 

Experience: 

  • MD or equivalent from accredited institution with 6+ years' relevant experience in drug safety in biopharmaceutical industry and in oncology clinical trials specifically. Candidates with advanced degrees in Health Sciences, Health Administration or Human Biology with significant patient safety experience (+10 years) may be considered for this role too.
  • Experience with conducting signal detection and benefit-risk evaluation throughout the product lifecycle
  • Experience with registrational clinical development programs and filings is required. Experience in oncology is preferred.
  • Experience in providing strategic input related to safety in product development.
  • Demonstrates the ability to provide input into study-related activities and documentation, regulatory submissions, DSURs, ISS, responses to regulatory agency inquiries, pharmacovigilance processes and projects, preparation of aggregate safety reports, risk management plans and experience with pharmacovigilance audits and inspections.
  • Experience of management of safety and pharmacovigilance vendors
  • Strong knowledge of relevant ICH, FDA and EU guidelines and regulations relevant to patient safety and pharmacovigilance activities.
  • Excellent understanding of the pharmaceutical industry and the future trends and developments in Drug Safety Pharmacovigilance.
  • Track record of strong personal performance combined with demonstrated ability to build and lead high performing teams.
  • Ability to establish and identify best practices for continuous improvement of quality, compliance, and process improvement in Patient Safety.
  • Demonstrates the ability to handle increasing responsibilities as scope may change relate to team growth and integration efforts cross-functionally.
  • Ability to help shape key department goals and objectives, drive process and operational efficiencies, and contribute to ongoing development of innovative best practices both internally and with cross-functional colleagues.
  • Ability to work independently, establish priorities, and execute with minimal guidance.

 

 

Attributes: 

  • Leadership skills in proactive strategy setting, priority evaluations, adapting to changes, conflict resolution, and effective partnership. 
  • Demonstrates strong verbal and written communication skills.
  • Demonstrates ability to work in a highly dynamic and science driven work environment  
  • 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.
  • Have impeccable professional ethics, integrity, and judgment.

 

The base pay range for this position is expected to be $275,500 - $297,000 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-MK1

Important Information >>>

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.

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.

Company

We exist to develop therapies that offer the potential to improve outcomes for women living with cancer. We approach these goals with a single-minded focus.

At Olema Oncology, we leverage our deep understanding of endocrine-driven cancers, nuclear receptors and mechanisms of acquired resistance with the goal of transforming the standard of care for women living with cancer by focusing on developing more convenient and effective therapies. Join us as we aim to design therapies for improving lives.

Why Join Us?

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 and offer competitive compensation and benefits.

Olema seeks 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.

Located in Cambridge, MA and San Francisco, CA

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Company info
Website
Location
780 Brannan Street
San Francisco
California
94103
United States

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