Associate Director, Clinical Science

Company Description

Job Description

Role Summary

The Associate Director Clinical Scientist contributes to the execution of the clinical development plan for the candidate drug products in collaboration with Project Leaders and Medical Directors. The clinical scientist will be involved in operationalizing studies, monitoring data in real time to ensure the integrity of the study and proactively identifying issues in the conduct of trials. They will also be responsible for medical review and data analysis for the purposes of both data cleaning and interpretation for regulatory documents and publications. They should be comfortable working in a multidisciplinary environment with frequent coordination between clinical operations, data management, biostatistics, regulatory, commercial, medical affairs, clinical pharmacology, translational medicine, and medical functions

Key Responsibilities

Monitoring of clinical data: 35%

• Perform high level clinical data review for quality and patient safety on an ongoing basis and escalate issues to the medical director as appropriate.
• Work collaboratively with data management, clinical operations, and medical monitors to ensure clinical data review is performed efficiently and in alignment with the needs of the trial.
• Communicate and escalate issues both internally and to investigators as appropriate.
• Work closely with the cross functional team on EDC builds according to the protocol specifications.

Generation and review of study documents: 20%

• Participate in authoring clinical documents including concept sheets/decks, clinical study protocols, investigator brochures, and regulatory documents.

Preparation of clinical outputs: 20%

• Generation of clinical outputs and initial interpretation for internal purposes and key external interactions including but not limited to investigator and DMC meetings.
• Work closely with Biostatistics, Pharmacovigilance and other stakeholders to review study outputs such as Tables/Listings/Figures and SAP updates.

Study team and site communication: 25%

• Prepare for and participate in regular study team meetings representing the interests of clinical development
• Organize and present data, study designs, and other information to advisory boards, investigator meetings, site interactions, study committees, and other internal and external settings.

Other duties and responsibilities as assigned.

Qualifications

Required Qualifications

• PhD or equivalent plus 5+ years of experience or bachelor/master's degree plus 10+ years of experience postgraduation that includes pharmaceutical industry experience in clinical drug/biologics development and the associated regulatory processes.
• Strong organizational skills to ensure that necessary data collection and documentation are accomplished for the required analysis and interpretation of clinical trial results.
• Ability to interact with internal team members and external partners effectively.
• Experience with clinical data analysis.
• Ability to influence decision-making within a multidisciplinary team in areas of expertise.
• Excellent communication and presentation skills.
• Business Travel: up to 20% business travel may be required
• Experience across Phase I-III drug development trials is preferred, with a focus on product development in Hematology-Oncology and/or rare disease.

Additional Information

Deciphera is committed to fair and equitable compensation practices. The base salary pay range for this role is $171,000 - $236,000. 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.