Associate Director, Clinical Scientist - Deciphera Pharmaceuticals

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.

We are seeking an Associate Director, Clinical Research Scientist with experience in managing multidisciplinary drug development projects. The successful candidate will interact within a multi-disciplinary, matrix work group ensuring that clinical and scientific issues are appropriately considered in the development and execution of individual clinical studies and overall development plans.  The Clinical Scientist will be involved in operationalizing studies, monitoring data in real time to ensure the integrity of the study, proactively identifying issues in the conduct of trials, and in medical review and analysis of data for the purposes of both data cleaning and interpretation for regulatory documents and publications.

This position will be filled at Associate Director and will be based in our Waltham office.

Key Responsibilities:

• Works closely with Medical Directors, Pharmacology, Discovery, external experts, and investigators to accumulate scientific and medical knowledge necessary to support clinical development plans and study designs and protocols
• Assists Medical Directors in creation of proposed concept sheets for clinical studies and may write protocols or work with medical writing to write protocols through incorporation of input from both internal and external experts
• Drives the clinical contribution to annual update of IB liaising with Toxicology, Pharmacology, Safety, Regulatory and Medical & Communication Experts
• Drives and integrates clinical contribution to answering regulatory queries and other submissions related to studies
• Monitors real time study data to ensure the integrity of the study and the study data and interacts with investigators and internal and external experts to resolve any study issues as they arise
• Involved in high level data cleaning activities requiring clinical judgment
• Involved in analysis of complex data for regulatory submissions, publications and design of studies and programs
• Acts as clinical/scientific expert on the products and studies in the therapy area
• Attends scientific meetings to remain abreast of new developments within relevant areas and to interact with investigators, and advisors
• Works with investigative sites to answer protocol related questions, resolve study conduct and design issues
• May present data, protocol designs and other information at advisory boards, investigator meetings, site initiations and other internal and external settings

Required Qualifications:

• Advanced degree in Life Sciences (or BS plus equivalent experience); Pharm D, or BSN or other equivalent clinical qualifications
• At least 5 years’ experience in product & clinical development in Biotech or Pharmaceutical company
• Understanding of GCP, ICH and regional/local regulations
• Experience in both early and late phase development
• Medical knowledge and experience in clinical development/ operations (Oncology preferred)
• Experience reviewing clinical data outputs
• Ability to perform literature searches and to utilize library services
• Ability to conduct basic data analyses using Excel and other tools
• Basic understanding of biostatistics to allow effective interaction with biostatistics expert
• May require approximately 15-30% travel

Preferred Qualifications:

• Teaching capability
• Excellent communication skills, both verbal and in writing
• Strong presentation skills
• Team player
• Ability to proactively predict issues and solve problems
• Ability to drive decision-making within a multi-disciplinary, multi-regional matrix team
• Diplomacy and positive influencing abilities
• Experience building data presentation plans

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.