Job Description

Job Description

We are seeking a Medical Director. This position will report to the Senior Medical Director of Pharmacovigilance and will be located in the Waltham office.

The Medical Director is responsible for global pharmacovigilance (PV) for marketed and/or investigational products, including review and analysis of safety data from post-marketing sources and from clinical trials, the identification and investigation of safety signals, management of benefit-risk profile for assigned compounds and products. Responsible for keeping upper management informed of safety issues. May represent Deciphera, Drug Safety and Risk Management at internal and external meetings. May be appointed as the Safety lead for a specific compound / product.

The successful candidate will demonstrate the flexibility and capability to function at a high level and will be comfortable working in an entrepreneurial environment to advance the safety understanding of compounds through life cycle. The individual who assumes this position will interact with multiple levels of management.

What Youll Do:

• Leads and provides input and oversight of the ongoing safety surveillance, benefit risk assessment and risk management activities for assigned product.
• Provides pharmacovigilance expertise to oversee and lead decision making based on risk/benefit evaluation, data analysis, interpretation, risk assessment and mitigation
• Perform medical review and assessment of adverse event reports for marketed and investigational products, adhering to documented procedures and company/vendor timelines
• Ensure that appropriate medical interpretation, consistency, and quality are applied to adverse event case assessment
• Provide medical support to cross functional team for protocol-related issues including protocol clarifications for safety topics, inclusion/exclusion determinations from safety perspective, and issues of patient safety and/or eligibility
• Assist with development of the protocol, Investigative Drug Brochure (IDB), Informed Consent Forms and/or Case Report Forms (CRFs)
• Perform review and clarification of trial-related Adverse Events (AEs), coding and consistency in assessment
• Perform medical case review of Serious Adverse Events (SAEs), including review of coding, consistency in assessment, case documentation and patient narrative
• Attend Kick-Off meetings, weekly team meetings, and vendor meetings, and other meetings as needed or requested
• Support inspections and audits, act as a subject matter expert for the assigned program (s)
• Provide training on product and medical review to vendor/ team members as needed
• Completes tasks on time or notifies appropriate person with an alternate plan.
• Participate in scientific literature review process for periodic safety reports, signal detection, and ad hoc as needed
• Attend/lead Safety committee meeting to support key decision-making, drive conclusions and develop next steps
• Work closely with Regulatory Affairs, and other cross functional team members to ensure oversight of critical safety issues and benefit-risk assessments
• Participate in development and maintenance of risk management plans and REMS as applicable.
• Key member on the Product Safety Committee; presentation of safety issues, signal evaluations, and proposed risk mitigation strategies
• Provide medical content and review of aggregate safety reports such as PSUR, DSUR, PADER, and other periodic reports
• Contribute to preparation of relevant regulatory documents and responses to regulatory agency, IRB, Site and Medical information queries
• Provide consultation for medically related questions from participating vendors, affiliates, etc.
• Use in-depth knowledge of Pharmacovigilance science and Regulatory Guidance to provide expertise and insight to cross-functional colleagues as appropriate
• Develop/assist in creation of internal SOP and review vendor SOPs as needed.
• Support in Inspections and Audits on-site,as needed.
• Expect to come on site on a quarterly basis, and ad hoc as needed.
• Other relevant duties as assigned

Qualifications

What Youll Bring:

• College degree in health sciences or related field is highly desirable. Relevant Training Certificate and/or other meaningful experience is mandatory
• A minimum of 3 years of relevant clinical operations experience in the pharmaceutical industry and/or CRO
• Demonstrates advanced knowledge of and appropriate experience of relevant software packages and Deciphera/vendor systems and programs
• Demonstrates thorough knowledge and understanding of key regulatory authorities, ICH Guidelines and GCPs
• Learns, interprets, and explains protocol requirements to others
• Manages components of clinical trials independently with limited general guidance from senior staff
• Demonstrates deep understanding of interdependencies of data, technology, vendor systems and metrics and differences across vendor abilities and responsibilities
• Strong verbal, written and presentation skills

Additional Information

Deciphera is committed to fair and equitable compensation practices. The base salary pay range for this role is $228,000.00 - $313,000. Actual compensation packages will depend on various factors, including, but not limited to depth of experience, education, skillset, overall performance and/or location.

Deciphera believes in providing a competitive compensation and benefits package to all employees. Our base salary is just one component of Decipheras competitive total rewards strategy that also includes annual performance bonus, a long-term incentive plan, full range of benefits and other incentive compensation plans (if applicable)

Benefits:

• Competitive salary and annual bonus.
• Comprehensive benefits package including medical, dental, vision insurance, 401(k) retirement plan with company match, and more.
• Generous parental leave and family planning benefits.
• Outstanding culture and opportunities for personal and professional growth.

Apply Now: Join us in our mission to improve the lives of people with cancer. Apply today to become a part of our dynamic team!

EQUAL EMPLOYMENT OPPORTUNITY INFORMATION

Deciphera is committed to equal employment opportunity and values diversity. To ensure that we comply with reporting requirements, we invite you complete the confidential survey at the end of this application. Providing this information is optional. It will not be accessible or used in the hiring process, and has no effect on your opportunity for employment. This information will also be treated confidentially. We are committed to make all hiring decisions and other employment decisions on a non-discriminatory basis.

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Job Tags

Full time, Work at office,

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