Company Description
Job Description
The Director, Clinical Science interacts within a multi-disciplinary, matrix environment, ensuring that clinical and scientific issues are appropriately considered in the development and execution of individual clinical studies and overall development plans.
While in this role, you will have the opportunity to be the lead clinical scientist for Clinical Development and Clinical Pharmacology studies of one or more programs.
Responsibilities include contributions to writing and review of clinical documents, supporting operationalization of studies, monitoring data in real time to ensure integrity of study endpoints, proactively identifying issues in the conduct of trials, and medical review and analysis of data for the purposes of data cleaning and interpretation for regulatory documents and publications.
This position will report to the Senior Medical Director, Clinical Development and work on-site at our Waltham, MA office or remotely. For Waltham employees Deciphera expects a minimum number of three days a week on site, with flexibility as to hours on site on any given day to accommodate work/life balance. Specific days and times spent in the office should be determined in conjunction with your manager.
What You'll Do:
Works closely with Medical Directors, Clinical Pharmacology, Translational Research, Discovery, Data Management external experts, and investigators to accumulate scientific and medical knowledge necessary to support clinical development plans.
Assists in the development of concept sheets/decks for clinical studies; contributes to authoring of clinical study protocols, amendments and related documents, as well as clinical sections of regulatory documents (IB, IND sections).
Contributes to clinical sections of study-related regulatory submissions and responses to regulatory queries.
Monitors real time study data to ensure study integrity; interacts with investigators and internal and external experts to resolve any study issues. Responsible for high level data cleaning activities requiring clinical judgment.
Will act as the primary point of contact between clinical science and data management, advice in EDC builds.
Involved in analysis of complex data for regulatory submissions, publications and design of studies and programs.
Clinical/scientific subject matter expert on products and studies in the therapeutic area.
May act as the medical Study Lead for ongoing clinical or clinical pharmacology studies.
Prepares data for and leads key study meetings including site safety calls and investigator meetings.
Contributes to preparation of abstracts, manuscripts, and presentations for external meetings.
Attends scientific meetings to remain abreast of new developments within relevant areas and to interact with investigators and advisors.
May present data, protocol designs and other information at advisory boards, investigator meetings, steering committees, site initiations and other internal and external settings.
Act as a functional leader across wider clinical scientist group with responsibility to mentor, coordinate, and act as a point of escalation and liaison across functions and with management. Achieve and maintain consistency in clinical scientist practices across studies by leading the CS team.
Qualifications
What You'll Bring: Advanced degree in Life Sciences/clinical/nursing field.
PhD or equivalent plus 8+ years of experience or Bachelors/Masters plus 10+ years of exp
Understanding of GCP, ICH and regional/local regulations
Experience in both early and late phase development
Ability to communicate with internal and external stakeholders at a high level of proficiency
Team-building spirit with can-do-together mindset
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
Requires approximately 10-30% travel
Additional Information
Deciphera is committed to fair and equitable compensation practices. The base salary pay range for this role is $194,000.00 - $267,000.00. Actual compensation packages will depend on various factors, including, but not limited to depth of experience, education, skillset, overall performance and/or location.
Deciphera believes in providing a competitive compensation and benefits package to all employees. Our base salary is just one component of Deciphera's competitive total rewards strategy that also includes annual performance bonus, a long-term incentive plan, full range of benefits and other incentive compensation plans (if applicable).
Benefits: Competitive salary and annual bonus.
Comprehensive benefits package including medical, dental, vision insurance, 401(k) retirement plan with company match, and more.
Generous parental leave and family planning benefits.
Outstanding culture and opportunities for personal and professional growth.
Apply Now: Join us in our mission to improve the lives of people with cancer. Apply today to become a part of our dynamic team!
EQUAL EMPLOYMENT OPPORTUNITY INFORMATION
Deciphera is committed to equal employment opportunity and values diversity. To ensure that we comply with reporting requirements, we invite you complete the 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. We are committed to make all hiring decisions and other employment decisions on a non-discriminatory basis.