Associate Director, Clinical Scientist - Deciphera Pharmaceuticals
Waltham, MA
About the Job
Deciphera, a member of ONO, 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.
Enabled by our proprietary drug discovery platform, Deciphera has developed a diverse pipeline of wholly-owned drug candidates. QINLOCK® (ripretinib) is Deciphera’s switch control inhibitor developed for the treatment of fourth-line GIST. QINLOCK is approved in Australia, Canada, China, the European Union, Hong Kong, Switzerland, Taiwan, the United States, and the United Kingdom. We wholly own QINLOCK and all of our drug candidates with the exception of a development and commercialization out-license agreement for QINLOCK in Greater China. In addition to QINLOCK, we have identified and advanced multiple product candidates from our platform into clinical studies, including vimseltinib and DCC-3116.
See here for more details on our portfolio.
We offer an outstanding culture and opportunity for personal and professional growth guided by our “PATHS” Core Values and how we work together. We are proud to be Great Place to Work Certified 2023 and rank #25 on Fortune’s Best Places to Work Small and Midsized Biotech Companies in 2023. Find more details about our award-winning culture here.
Job DescriptionWe 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.
What You'll Do:
- 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
What You'll Bring:
- 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
Additional Information
Deciphera offers a comprehensive benefits package that includes but is not limited to 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 with company match
- Life and Supplemental life insurance for family
- Short and Long Term Disability insurance
- Health savings account with company contribution
- Flexible spending account for either health care and/or dependent care.
- Family planning benefit
- Generous parental leave
- [if applicable] Car allowance
Deciphera, a member of ONO, is a 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.