Associate Clinical Project Manager/Clinical Project Manager

Deciphera

  • Waltham, MA
  • Permanent
  • Full-time
  • 1 month ago
  • Apply easily
Company Summary:

Deciphera Pharmaceuticals is a commercial 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 in clinical studies, QINLOCK is Deciphera's first FDA-approved drug, a switch-control kinase inhibitor for the treatment of fourth-line gastrointestinal stromal tumor (GIST). QINLOCK, an oral oncolytic, is also approved in Canada and Australia for the treatment of fourth-line GIST.

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.

Our Science and Our Pipeline:

Deciphera is developing novel small molecule drug candidates to improve the lives of cancer patients by addressing key mechanisms of tumor and drug resistance that limit the effectiveness of many cancer therapies. Our pipeline of drug candidates is designed to stop cancers from growing and spreading by inhibiting mutant forms or over expression of a family of enzymes called kinase. Enabled by our proprietary kinase switch control inhibitor drug discovery platform, we have developed kinase switch control inhibitors that interact at a molecular level in a way that is distinct from other kinase inhibitors and are designed to generate higher and more durable rates of response.

We have developed a diverse pipeline of differentiated, wholly owned, orally administered, oncology drug candidates that includes, among others, our recently approved product, QINLOCK (ripretinib), a broad-spectrum KIT and PDGFRa kinase switch control inhibitor is approved for the treatment of fourth-line GIST. Our follow-on study of ripretinib, the INTRIGUE study, is a pivotal Phase 3 trial in second-line GIST. We also have two additional clinical-stage programs for drug candidates DCC-3014 and rebastinib, both immune-oncology (or immunokinase) inhibitors, targeting the kinases CSF1R and TIE2 respectively. Two research-stage programs are in the pipeline as well.

Position Summary:

We are seeking a Senior Clinical Project Manager or Clinical Project Manager to support the management of clinical trials from initiation to completion while partnering with internal and external cross-functional disciplines.

This position will report to a member of the Clinical Operations leadership team, and will eventually be based out of our Waltham, MA offices.

Key Responsibilities
  • Dependent on the level, the Associate CPM or CPM will:
  • Represent or lead the study team in designing, developing and delivering the study to agreed-upon timelines
  • Lead or participate in the planning and communication with cross-functional teams to ensure proper execution and conduct of the clinical trials
  • Serve as primary contact or as a resource for CRO and vendor personnel
  • Provide oversight/management of CROs and vendors
  • Oversee and monitor the management of clinical studies ensuring they are conducted in compliance with agreed upon study plans through regular CRO and/or investigator site contact
  • Monitor status of clinical data collection of assigned clinical trials.
  • Prepare potential investigator site lists and assists with their evaluation for inclusion in the study
  • Review and approves study-related plans generated by CROs, vendors and ensures the documentation are in accordance with GCP, regulatory requirements and consistent with the protocol
  • Assist study team with preparation for audits/inspections
  • Participate in the review and finalization of clinical study-related documents such as protocols, protocol amendments and CSRs
  • Present on-going study updates to Clinical Leadership
  • Provide oversight for the setup, maintenance, and close out of the Trial Master File and ensure it is complete and inspection ready
  • Responsible for assuring compliance with internal SOPs, FDA regulations and GCP collection and query trends
  • Track 1572s and liase with Regulatory for IND submission as well as other essential documents as appropriate
  • Assist with Investigator Meeting Planning and may present at the meeting
  • Perform TMF QC
  • Assist in Essential Document Packet (EDP) review and approval
  • May perform SIVs
  • May provide study-specific training to vendors, CRAs and site staff
Required Qualifications:
  • Bachelor's degree in in health science or related field
  • A minimum of 3 years of relevant clinical operations experience in the pharmaceutical industry and/or CRO (oncology experience preferred)
  • Excellent communication (verbal and written), organizational, and problem-solving skills
  • Excellent Microsoft Office skills
  • Strong attention to detail
  • Working knowledge of ICH guidelines and GCP
  • Ability to work collaboratively with others within and external to the company
  • Minimum of 4 years in clinical trial management (oncology experience preferred)
  • Ability to travel approximately 20%
Deciphera offers competitive compensation, including equity-based compensation, and a comprehensive benefits package that includes medical, dental, vision, 401(k) retirement plan, life insurance and a flexible spending account for either health care and/or dependent care.

Deciphera