Senior Director, Patient Safety Sciences

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 knowledge, experience, 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 - $297,000annually, 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.

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