New · posted Nov 6
Deciphera Pharmaceuticals · Biotechnology
Director, Clinical Operations
- Remote, US
- Remote
- Full-time
- Director
The role
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. The spirit of collaboration that has brought medications to life continues to guide how we operate, grow, and discover new breakthroughs. We cultivate an inclusive culture that values curiosity, creativity, and shared accountability—empowering individuals to challenge the unknown together. Learn more about Deciphera, a member of Ono Pharmaceutical Co., Ltd., by visiting our website: https://deciphera.com
The Director, Clinical Operations provides strategic and operational leadership across multiple clinical programs and studies, translating clinical development strategy into strong operational execution. This role is responsible for ensuring programs are delivered with quality and accountability across timelines, budgets, and external partnerships.
The Director will initially oversee approximately two clinical programs and lead and develop a small Clinical Operations team. This role is suited for an experienced Clinical Operations leader who has progressed beyond individual study management into broader program ownership while remaining comfortable with hands-on execution in a fast-paced biotech environment.
Role Specific Additional Information
This role will involve regular collaboration with global colleagues, including teams in Japan, which may occasionally require early-morning or evening meetings. Some travel will also be required for program activities, internal meetings, and industry conferences.
Deciphera believes in providing a fair, equitable, and 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)
What you need
Preferred Capabilitiesnice to have
- Experience supporting global clinical programs, including collaboration with teams and partners in Japan.
- Oncology or rare disease clinical development experience.
- Experience with eTMF, EDC, IWRS, and RBQM platforms.
- Strong clinical program and study budget management experience.
- Experience working within a small-to-midsize biotechnology organization.
What you'll do
Clinical Program Strategy & Execution
- Provide Clinical Operations leadership across multiple programs and studies, ensuring alignment with broader development objectives.
- Oversee clinical trial planning and execution, including timelines, budgets, quality, resourcing, operational risks, and key metrics.
Team & Cross-Functional Leadership
- Lead and develop Clinical Operations team members and provide oversight of contractors and external resources.
- Partner across Clinical Development, Regulatory, Data Management, Safety, and other functions to support effective clinical program execution.
CRO & Vendor Management
- Lead CRO and vendor relationships, ensuring strong performance, financial accountability, quality, and delivery against program expectations.
Program Communication & Regulatory Support
- Communicate program status, risks, and recommendations effectively to senior and executive leadership.
- Contribute to regulatory documentation and ensure clinical deliverables support submission requirements and global regulatory expectations.
Other duties and responsibilities as assigned
- Bachelor’s or Master’s degree in health science or a related field.
- 12+ years of clinical research experience, including at least 10 years in clinical trial management and Clinical Operations leadership.
- Demonstrated ownership of multiple clinical programs and experience overseeing several clinical trials concurrently.
- Significant experience leading complex clinical trials with accountability for timelines, budgets, quality, and operational delivery.
- Strong CRO and vendor management experience, including performance oversight, financial accountability, risk management, and issue escalation.
- Demonstrated experience leading and developing Clinical Operations team members.
- Ability to communicate effectively with senior and executive leadership and work across functions and geographies.
- Strong knowledge of GCP, ICH, FDA, and global clinical development requirements.
Pay and benefits
$216,000 – $263,000 a year
Employer providedCompetitive 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 opportunity, accessibility and legal noticesDeciphera Pharmaceuticals's statements, word for word
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.
Job intelligence
The context around this role
Live data · November 6, 2026
Salary intelligence
How the pay compares
This role's midpoint is 2% above the US median for Clinical Operations roles at this level.
This roleEmployer provided
Director roles in Massachusetts8 roles publishing pay
Director roles in the US41 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $216,000 | — | $263,000 |
| Massachusetts (middle half) | $194,125 | $200,000 | $221,125 |
| All US (middle half) | $202,000 | $235,000 | $244,000 |
This role: Deciphera Pharmaceuticals's own published range. Comparisons: the base pay employers published on open Clinical Operations roles at the same level on Regulatory Jobs, November 6, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Clinical Operations
The general path across 105 open Clinical Operations roles on Regulatory Jobs, with the titles they carry most. Not Deciphera's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 25 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership12
- Clinical trial conduct11
- GMP and compliance1
- Documentation and SOPs1
- Regulatory submissions1
- Quality systems and risk1
- Data and digital systems1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Clinical Operations work in biotechnology, led by the one this posting names, each linked to the agency or standards body that publishes it.
- ICHICH E6(R3) good clinical practice(official source, opens in a new tab)The international standard for the design, conduct and reporting of clinical trialsNamed in the posting
- FDA21 CFR Part 312(official source, opens in a new tab)Investigational New Drug applications and sponsor duties in drug trials
- FDA21 CFR Part 50(official source, opens in a new tab)Protection of human subjects: informed consent in FDA-regulated trials
- FDA21 CFR Part 56(official source, opens in a new tab)Institutional review boards for FDA-regulated clinical investigations
- PMDAJapan PMDA(official source, opens in a new tab)Japan's Pharmaceuticals and Medical Devices Agency
- EUEU Clinical Trials Regulation 536/2014(official source, opens in a new tab)How clinical trials of medicines are authorized and run in the EU, through CTIS
- ICHICH E8(R1)(official source, opens in a new tab)General considerations for clinical studies and quality by design in trials
- HHS45 CFR Part 46 (Common Rule)(official source, opens in a new tab)The federal policy for the protection of human research subjects
- NIH42 CFR Part 11(official source, opens in a new tab)Clinical trial registration and results reporting on ClinicalTrials.gov
- FDAFDA Bioresearch Monitoring (BIMO)(official source, opens in a new tab)FDA inspections of clinical investigators, sponsors, IRBs and GLP labs
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- HHSHIPAA Privacy Rule(official source, opens in a new tab)Federal protections for individually identifiable health information
- EUGDPR (Regulation 2016/679)(official source, opens in a new tab)The EU General Data Protection Regulation for personal data, including health data
- ICHICH E9 and E9(R1)(official source, opens in a new tab)Statistical principles for clinical trials and estimands
- FDA21 CFR 314.80 and 600.80(official source, opens in a new tab)Postmarketing reporting of adverse drug and biologic experiences
- ICHICH E2A to E2F(official source, opens in a new tab)Clinical safety data management, expedited reporting and periodic safety reports
Company hiring pulse
Deciphera on Regulatory Jobs
- 9
- Open roles
- 9
- Distinct roles
- 2
- Locations
By discipline
- Clinical9 100%
By level
- Director6 67%
- Manager3 33%
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Director, Clinical Operations at Deciphera
Open until filled. $216K–$263K a year, employer provided.