Manager, Translational Medicine Operations - #134868
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 and our European operations are run out of Switzerland.
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 experienced, highly-motivated and engaged (Senior) Scientist, Translational Medicine Operations. The successful candidate will have an opportunity to build upon their experience in Translational Medicine or Preclinical Research with ample opportunity for growth in support of clinical programs and biomarker development. The successful candidate will work closely with our Clinical Operations, Clinical Development, and the Preclinical Research Team to assist in developing clinical biomarkers for development candidates as well as manage clinical trial samples and vendors in compliance with protocols, regulatory guidance, and timelines. The (Senior) Scientist will be an individual contributor working with the other Translational Medicine Scientists to manage Translational Medicine operational activities for multiple clinical trials as well as assist in developing new biomarker assays. He/she will be an excellent communicator within the Translational Medicine Team as well as across functions.
This position will be located in Waltham, MA and will report to the Associate Director, Translational Medicine Operations located in the Waltham, MA office.
What You’ll Do:
- Serve as Translational Medicine operations lead for multiple clinical studies
- Support Translational Medicine Scientists in developing and implementing clinical biomarker strategies to address the key program-level questions in alignment with cross-functional colleagues in both clinical development and preclinical biology
- Represent Translational Medicine on cross-functional teams
- Work closely with Clinical Operations, Data Management, and Translational Medicine to coordinate and manage the sample collection for on-going and planned clinical trials that have translational medicine objectives in their design
- Help implement standardization of processes to enable efficient growth of team deliverables
- Ensure robust chain-of-custody for clinical trial specimens
- Manage kit preparation, sample collection procedures, shipping requirements, analytical data collection/reporting
- Provide oversight of multiple CROs from a technical, budget and timeline perspective
- BS, MS, or PhD degree in science with a strong track record in bio-pharma industry working on clinical development projects and in a cross-functional team environment
- 5+ years (BS), 2-5 years (MS) or 1+ years (PhD) of experience in industry with a focus on biomarker development in preclinical or clinical development.Experience with CRO/vendor management is preferred
- Biomarker data management and sample management experience is highly desirable
- Technical expertise and/or knowledge of immunohistochemistry, flow cytometry, ELISA, NGS and RNA Seq
- Data analysis experience
- Experience with contract and budget development and management
- Strong communication and interpersonal skills and ability to build collaborative relationships in a cross-functional environment is a must
- Knowledge of GCPs for global compliance
- Strong project management skills and organizational skills to prioritize and handle competing priorities
- Excellent problem-solving skills
What Deciphera will Bring:
Deciphera offers competitive compensation, including equity-based 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 with company match
- Life and Supplemental life insurance for family
- Short and Long Term Disability insurance
- ESPP offering
- 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
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.