- Provide medical leadership and management/development to direct reports within Drug Safety:
- Accountable for product safety oversight and strategies/activities performed by direct reports including:
- Strategic advisement on clinical development plans, design of clinical protocols
- Responsible for safety content of IB and ICFs and support of IDMCs
- Analysis strategy for Integrated Summary of Safety (ISS) and benefit-risk content within the Clinical Overview documents associated with regulatory filings
- Responsible for the content of Risk Management Plan/ REMS as required
- Responsible for content of aggregate safety reports (i.e., DSUR, PSUR) including assessment of benefit-risk
- Advisement on the design of post-approval safety studies
- In the role as a Global Safety Officer for assigned investigational and/or marketed products:
- Lead product safety surveillance, and signaling activities for assigned product(s) in collaboration with DSPV staff (internal or external CRO's as deemed appropriate)
- Acquire a deep understanding of the disease process and assigned product(s) efficacy and safety profile including a working knowledge of other products in the class and therapeutic space
- Ensure that routine signaling activities, assessment and investigation are completed and documented in a timely manner
- Ability to effectively communicate and respond to product safety queries from all sources including ethics committees and regulatory authorities
- Lead product benefit-risk assessment and presentation to the Safety Committee and any needed actions to update patient safety information
- Lead Drug Safety and Pharmacovigilance representation in the assigned program team and clinical development team and respective study management teams:
- Lead the Safety Committee:
- Medical and Safety expertise towards Business Development/Due Diligence activities for Mural
- In the role as the lead for Pharmacovigilance requirements:
- Oversees Murals PvG processes and collaborations with external PvG vendors
- Ensures compliance with applicable regulations and standards for reporting of adverse events to regulatory authorities
- Oversees and contributes in the preparation and submission of safety reports, Periodic reports, investigator communications and product labeling (when applicable)
- Oversees the development, preparation and completeness of reports for internal management as well as regulatory authorities
- MD, or MD PhD, or MD MPH required
- Minimum of years of experience in Drug Safety/Benefit Risk Management expertise
- Prior experience in patient care, clinical development (including early clinical), and/or knowledge of clinical pharmacology desirable
- Safety/medical experience in the oncology space is highly desirable
- Experience ensuring pharmacovigilance deliverables and compliance obligations are met
- High emotional intelligence with experience managing and developing direct reports as well as highly effective teams
- Demonstrated strategic and critical thinking skills
- Demonstrated leadership as well as the ability to perform effectively in a matrixed and dynamic environment, ability to lead and collaborate within complex organization, across functions; to work in an entrepreneurial culture
- Excellent communication (oral and written) as well as organizational skills
- Demonstrated sense of urgency and accountability for both individual and team-owned work products
- Knowledge of pre- and post-marketing US and EU regulations
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Executive Medical Director, Drug Safety and Pharmacovigilance - Waltham, United States - MURAL ONCOLOGY PLC
Description
The Mural team brings together oncology expertise and passion to make an impact on patients' lives. We are seeking a highly motivated individual to join our team.Overview
The Executive Medical Director serves as the functional head of DSPV, and is accountable for the management, mentoring and development of assigned benefit-risk management staff as well as serving as a global safety officer for assigned investigational and/or marketed products.
Reporting to the SVP of Clinical Development, this role will be highly visible providing safety leadership and advisement in company-wide forums and initiatives.
The successful candidate will have demonstrated prior career success as a product safety physician, fulfilling pharmacovigilance requirements and managing/developing individuals and highly effective teams.
This leader will be expected to roll-up their sleeves and help do the work in addition to managing direct reports.
Key success factors also include building high trust, accountability and demonstrating a sense of urgency in leading critical projects, showing the capability to work either independently or collaboratively and to be able to effectively communicate with varied stakeholders both verbally and in writing.
The individual who assumes this position will interact with multiple levels of management within Mural, external stakeholders in the medical community, as well with global regulatory authorities.
Key Responsibilities
Mural Oncology is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, gender expression and identity, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.
Mural Oncology also complies with all work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.
Mural Oncology is an E-Verify employer.
