Senior Director - Medical Risk Management - Cubist Pharmaceuticals - Lexington

Job description
Position Summary:

The Sr. Medical Director, MRM leads global product safety assessment and risk management for the continuous evaluation of benefit and risk profile of Cubist compounds and products, in accordance with applicable regulatory requirements, guidelines, standards. He/she is the expert in medical risk management and signal detection activities, ensuring sensitive, specific, adequate and rapid assessment of risks, and will represent Cubist medical risk management position for patient safety. His/her responsibilities include establishing adequate governance model to manage safety information and decision making process through safety management teams across products, in alignment with the overall safety governance model in place at Cubist, using the best standards and a holistic approach that includes pharmacovigilance, epidemiology, biostatistics and information technologies.

Major duties and specific responsibilities include:

•Partners with key functions within the company, communicating proactively on risks and risk management, establishing a clear path for managing risks and decision making process.


•Champions transformation and continuous process improvement. He/she has a strategic and global mindset allowing to assess any risk impact for all patients worldwide, taking into consideration local specificities and regulations, and has a broad understanding of global organizations and international regulations.

•Ensures that a comprehensive and state of the art signal detection and risk evaluation process in place across programs and products at a global level.

•Creates and executes risk management strategic programs in line with best standards supporting the company product development.

•Ensures that best governance model for detecting, reviewing, recommending action and ensuring decision on risks mitigation is in place with involvement of all cross functional representatives.

•Leads the development and maintenance of Development and/or Post-Marketing Risk Management Plans and Risk Evaluation and Mitigation Strategies when needed for assigned products, including measuring the efficiency of actions.

•Approves ad-hoc or specific safety reports, such as Health Hazard Evaluations, Periodic Safety Reports (PSURs, PBRERs, DSURs); ensuring that reference safety documents such as Investigator Brochure, Core Company Data Sheet and local labeling reflects the actual knowledge on Cubist risk profile.

•Communicates with and represents GPV-MRM analysis of safety risks and risk mitigations within project/product teams, with external partners, key opinion leaders, and Health Authorities, and during internal and external negotiations with partners.

•Oversees and provides guidance to PV Operations on individual cases review for medical assessment, coding, documentation and follow-up of reports.

•Fosters a learning organization; organizes Pharmacovigilance and Risk Management intelligence.

•Participates in resource and budget planning and management, and setting of group strategy and vision.

•Mentors PV and Cubist staff on new initiatives, regulatory changes and new processes.

Minimum Basic Qualifications:

•MD/DO with at least 10-15 years of PV experience in both development and marketed products including risk/benefit analysis and safety assessment.

•Minimum of 10 years of leadership role in global PV organizations

•Solid knowledge of US and European drug safety regulations in both development and marketed products.

•In depth knowledge of Good Vigilance Practices (GVP) and Good Clinical Practices (GCP) related to safety documentation and reporting.

Preferred Qualifications and Experience:

•Board certification/board eligibility, or equivalent is desirable.

•Successful track record of building PV organization.

•Demonstrated experience in the reviews of relevant safety information from all sources, analysis of safety data and produced definitive documents on safety issues for use through the Company.

•Demonstrated experience with development, authorship and review of aggregate reports (PSUR, PBRER, DSUR, ASR, IND annual, NDA annual, REMS, RMP, etc.)

•Multiple interaction with Health Authorities on safety issues, crisis management, product recall, urgent safety notifications.

•Demonstrated transformation or organizational improvements of Risk Management or PV functions

•Demonstrated technical writing skills (published medical or scientific papers).

•Ability to work effectively in cross departmental, cross organizational teams.

Competencies:

•Natural born leader with the ability to define and share vision, engage and motivate individuals and groups within and outside PV.

•Communicate efficiently on complex topics, manage executive communication with ease. Ability to express ideas and information clearly and accurately.

•Ability to see the global picture and the intricacies/dependencies of all global functions within pharmaceutical industry.

•Ability to foster a culture of performance, process improvement and compliance while facilitating open ideas, challenges, creativity and accountability. Create a safe, respectful and open environment where diversity and differences of opinion are encouraged through a creative debate ensuring the best path for decision and action.

•Ability to mentor and develop individuals but to also to listen and learn from others, irrespective of their responsibilities or positions.

Work Environment:

•This is a Lexington-based position that requires significant interactions with internal colleagues from other departments and with external colleagues, consultants, key leaders and regulatory authorities. Works within Cubist’s established policies and procedures and ensures alignment of their work with Cubist’s values.

Physical Demands:

•Minimal travel required

Enter your email address:

Refer This Job To Your Friends And Help Them To Find Jobs!