Global Safety Officer, Medical Director, Pharmacovigilance

Deciphera is a biopharmaceutical company focused on discovering, developing and commercializing important new medicines to improve the lives of people with cancer. We are leveraging our proprietary switch-control kinase inhibitor platform and deep expertise in kinase biology to develop a broad portfolio of innovative medicines.

In addition to advancing multiple product candidates from our platform in clinical studies, QINLOCK® is Deciphera’s FDA-approved switch-control kinase inhibitor for the treatment of fourth-line gastrointestinal stromal tumor (GIST). QINLOCK is also approved for fourth-line GIST in Australia, Canada, China, and Hong Kong.

We offer an outstanding culture and opportunity for personal and professional growth based on our “PATHS” Core Values:

• Patients – places the importance of improving the lives of patients and their caregivers at the forefront of every day’s work.
• Accountability – for our performance and the way we work with coworkers and other stakeholders.
• Transparency – in our intent and actions to both internal and external stakeholders.
• Honesty and Integrity – fosters trust and strives to deliver on our and the company’s promises.
• Stewardship – values and uses wisely the resources and investments provided to the company.

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 You’ll 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, [LL1] [FA2] as needed.
• Expect to come on site on a quarterly basis, and ad hoc as needed.
• Other relevant duties as assigned

 [LL1]I simply added that they should expect to support the inspections and audits on-site. Does this work in a more simplified format?

 [FA2]I think quarterly onsite is different from the on-site audit and inspection

• MD from accredited institution of Medical Education (board certified preferred; board eligible or OUS equivalent)
• Minimum of 5 years of experience in Pharmacovigilance/Drug Safety with development and marketed products in a biopharmaceutical industry setting
• Excellent scientific/clinical and analytical knowledge base, with ability to assess data and understand the safety/medical implications
• Excellent oral and written communication skills including ability to present to large internal/external groups
• Multi-tasking with the ability to successfully manage multiple critical issues simultaneously
• Work productively in a high-pressure environment
• Strong ability to understand and evaluate technical, scientific and medical information; exposure to clinical data collection, assessment, and analysis
• Proficiency in MedDRA coding, Microsoft Excel, Word, and PowerPoint; safety database experience preferred; ability to learn new computer systems as they are implemented
• Working knowledge of global drug development and pharmacovigilance guidelines and regulations
• Highly detail-oriented, well-organized, and able to prioritize multiple tasks to meet deadlines
• Excellent teamwork and collaboration

What Deciphera will Bring:

Deciphera offers competitive compensation and a comprehensive benefits package that includes the following:

• Non-accrual paid time off
• Summer vacation bonus
• Global, company-wide summer and winter shutdowns
• An annual lifestyle allowance
• Monthly cell phone stipend
• Internal rewards and recognition program
• Medical, Dental, and Vision Insurance
• 401(k) retirement plan
• Life and Supplemental life insurance for family 
• Short- and Long-Term Disability Insurance
• Health savings account
• Flexible spending account for either health care and/or dependent care
• Family Planning benefit

All your information will be kept confidential according to EEO guidelines.

EQUAL EMPLOYMENT OPPORTUNITY INFORMATION

Deciphera is committed to equal employment opportunity and values diversity. To ensure that we comply with reporting requirements and to learn more about how we can increase diversity in our candidate pool, we invite you to voluntarily provide demographic information in a 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.  Our commitment to increasing diversity in our candidate pool does not affect our commitment to equal employment opportunity, including our ongoing commitment to make all hiring and other employment decisions solely on a nondiscriminatory basis.