Associate Director, Clinical Science

Regulatory Jobs; United States; Remote; USD 171,000 - 236,000; Full time

Benefits offered by this job

Annual bonus

401(k) with company match

Medical, dental, vision insurance

Parental leave

Job summary

Deciphera, a biopharmaceutical company, is advancing clinical programs with a focus on hematology-oncology. The Associate Director Clinical Scientist contributes to executing development plans, operationalizes studies, and ensures data integrity for regulatory documents and publications.

The role involves coordinating with clinical operations, data management, biostatistics, regulatory, and medical affairs in a multidisciplinary environment, with travel up to 20% as needed.

Qualifications

• PhD or equivalent plus 5+ years of pharmaceutical industry experience in clinical drug/biologics development and regulatory processes.
• Bachelor’s or Master’s with 10+ years in pharmaceutical development and regulatory exposure.
• Experience with clinical data analysis and regulatory documentation is essential.
• Excellent communication and presentation skills are required.
• Ability to travel up to 20% for site and advisory interactions.

Responsibilities

• Monitor clinical data quality and patient safety; escalate issues to the medical director as appropriate.
• Collaborate with data management, clinical operations, and monitors to ensure efficient data review.
• Author and review clinical documents including protocols, investigator brochures, and regulatory submissions.
• Prepare for and participate in study team meetings, advisory boards, and investigator meetings; present data and study designs.

Skills

Clinical data analysis

Communication skills

Presentation skills

Cross-functional collaboration

Business travel

Education

PhD or equivalent + 5+ years pharma experience

Bachelor’s or Master’s + 10+ years pharma experience

Job description

Deciphera, a member of Ono Pharmaceutical Co., Ltd., is a biopharmaceutical company focused on discovering, developing, and commercializing important new medicines and providing hope to people living with cancer, neurologic and autoimmune disease. Deciphera isleveragingits proprietary switch-control kinase inhibitor platform and deepexpertisein kinase biology to develop a broad portfolio of innovative medicines. In addition to advancing multiple product candidates fromDeciphera’splatform in clinical studies, QINLOCK® (ripretinib) isDeciphera’sswitch-control kinase inhibitor approved in many countries including the European Union and the United States for the treatment of adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib. ROMVIMZA® (vimseltinib) is a kinase inhibitor approved in the United States for adult patients with symptomatictenosynovialgiant cell tumor (TGCT) for which surgical resection will potentially cause worsening functional limitation or severe morbidity, and in the European Union for adult patients with TGCT associated with clinically relevant physical function deterioration and in whom surgical options have been exhausted or would induce unacceptable morbidity or disability.

The spirit of collaboration that has brought medications to life continues to guide how weoperate, grow, and discover new breakthroughs. We cultivate an inclusive culture that values curiosity, creativity, and shared accountability—empowering individuals to challenge the unknown together.

Deciphera offers competitive compensation, including equity-based compensation,and a comprehensive benefits package that includes medical, dental, vision, 401(k) retirement plan, lifeinsuranceand a flexible spending account for either health care and/or dependent care.

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 elevate 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.

• 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.

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.

EQUAL EMPLOYMENT OPPORTUNITY INFORMATION

Deciphera is committed to equal employment opportunity and values diversity. We are committed to make all hiring decisions and other employment decisions on a non-discriminatory basis.