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.

Deciphera (NASDAQ: DCPH) is a publicly traded company headquartered in Waltham, Massachusetts. Our state-of-the-art research facility is located in Lawrence, Kansas.

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.

The Sr. PV Scientist serves as a critical medical analytic and coordinating role in partnership with the Safety Physician/Medical Monitor for investigational and/or marketed product(s). The Sr. PV Scientist is expected to be equally effective in working collaboratively and independently. She/he will support activities such as signaling, safety data analyses/authorship for ad hoc queries, regulatory submissions including NDA, MAA and aggregate reports. She/he will ensure that these are of high quality and are completed and submitted according to required timelines. For investigational products, this role may also participate in protocol design, safety CRF development, safety monitoring plan, support of DSMB activities, coding review as well as SAE reconciliation activities. The Sr. PV Scientist also supports development and maintenance of SOPs and work instructions regarding signaling, ad hoc and aggregate safety and risk management reports as applicable.

The Role:

The successful candidate will have demonstrated adequate experience of the above responsibilities in their work. Accountability and a sense of urgency in supporting these projects is a key success factor for this role. Demonstrated ability to review and analyze clinical data, make assessments, and communicate effectively both verbally and in writing.

The position will report to the Risk Management Lead and will be in the Waltham, MA office/remote.

What You’ll Do:

• Serve as key analytic and safety support lead in close collaboration with the product Safety Physician/Medical Monitor.
• Assist with regulatory submissions for new products, formulations, or indications (NDA/BLA, MAA), in partnership with the safety physician and other functional experts.
• Responsible for signaling activities, review and documentation of all signal management activities along with the product Safety Physician and product complaint staff. This includes performing signal investigations and drafting signal investigation reports.
• Manage literature review plan for marketed products and medicinal products under development.
• Prepare material for Safety Committee and document/archive meeting minutes.
• Coordinate ad hoc safety query or health hazard evaluation response plan in conjunction with the Safety Physician, Biostatistics and others as needed; including performing analysis and drafting of query responses for review and finalization.
• For investigational product(s): support safety review of protocols and CRFs, safety content of IB, ICF, and as appropriate support DSMB activities. Assist with lab and AE data review, associated with clinical study reports.
• Prepare aggregate safety reports (e.g., DSURs, PADERs, PBRERs), including project management, safety database requests, understanding and writing the content, assimilating information from other groups, and quality checks.
• Contribute towards RMP updates and REMS reports as appropriate.
• Collaborate with the Safety Physician and Clinical representatives and author the Reference Safety Information (RSI) for multiple development products.
• Demonstrate knowledge and stay up to date to ensure compliance with current and applicable global PV regulations and guidelines (e.g., CIOMS, EMA, FDA, ICH, etc.)
• Contribute to process improvement and consistency of cross-product processes.
• Train, mentor, and oversee junior members of the team.
• Maintain inspection readiness.
• Perform other tasks as assigned or required.

• Minimum 4-5 years relevant medical, scientific/clinical, or pharmaceutical experience, including experience in drug safety serving in a PV Scientist or similar role.
• Advanced degree (PharmD, RN, MD, PhD, MPH, NP, MS)
• Demonstrated experience in analysis, and interpretation of medical and scientific data.
• Excellent communications skills.
• Demonstrated ability to work effectively in a team environment (including Safety, Clinical Development, Medical Affairs, Clinical Operations, and Regulatory), as well as independently.
• Demonstrated experience in signaling, authoring of aggregate data reports, and responses to regulatory agency requests.
• Strong knowledge of pharmacovigilance and drug development, including knowledge of applicable clinical trial and post-marketing safety regulations.
• Familiarity with case processing, expedited reporting rules, and safety database concepts.
• Strong knowledge/proficiency with Microsoft Office Suite and Argus Safety systems.

What Deciphera will Bring:

Deciphera offers competitive compensation, including equity-based compensation, and a comprehensive benefits package that includes the following:

• Summer vacation bonus
• Global, company-wide summer and winter shutdowns
• An annual lifestyle allowance
• Internal rewards and recognition program

Deciphera (NASDAQ: DCPH) is a publicly traded company headquartered in Waltham, Massachusetts. Our state-of-the-art research facility is located in Lawrence, Kansas and our European operations are run out of Switzerland.

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.

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.