Medical Director, Clinical Development (Neurology)

Deciphera Pharmaceuticals; Waltham (MA); On-site; USD 248,000 - 341,000; Full time

Benefits offered by this job

Annual bonus

Benefits package

Parental leave

Growth opportunities

Job summary

Deciphera Pharmaceuticals, a biopharma focused on innovative cancer medicines, is seeking a Medical Director to lead clinical development activities for multiple programs. You will drive trial design, monitoring, and regulatory submissions, coordinating with allied functions and external partners.

In addition to strategic leadership, you will mentor clinical scientists, contribute to BD activities, and help advance Deciphera’s pipeline.

Qualifications

• Medical Degree or equivalent with 8+ years of combined relevant academic and industry experience, including 3+ years of work on clinical trials.
• Experience with clinical trial design, conduct, and medical monitoring.
• Understanding of GCP/ICH and regional/local regulations.
• Familiarity with data review/analytics tools (Rave, J-Review, Spotfire, etc).
• Outstanding leadership, team, presentation, written and oral skills.
• Collaborative and flexible in personal interactions at all levels of the company.
• Willingness to accommodate meetings across time zones and travel up to 30%.

Responsibilities

• Provide clinical development leadership to one or more programs (75%).
• Contribute to clinical development strategy aligned with enterprise goals.
• Serve as medical monitor for one or more studies.
• Perform ongoing clinical trial data review and cleaning with clinical science and pharmacovigilance.
• Attend and contribute to study team meetings.
• Present clinical trial findings to management.
• Author clinical documents (protocol, investigator brochure).
• Author clinical portions of regulatory documents (IND, CTA, NDA, MAA or equivalent).
• Develop and manage relationships with key opinion leaders for clinical programs.
• Organize, manage and lead Steering Committees and contribute to advisory boards.
• Contribute to writing manuscripts and external publications.
• Contribute to clinical, scientific and commercial development of product candidates.

Skills

Leadership

Communication

Problem solving

Strategic planning

Travel availability

Education

Medical Degree or equivalent

Tools

Rave

J-Review

Spotfire

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 is leveraging its 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 from Deciphera’s platform in clinical studies, QINLOCK® (ripretinib) is Deciphera’s switch-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 symptomatic tenosynovial giant 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 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.

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.

The medical director will provide clinical development leadership at the study level for one or more clinical stage assets in early and/or late development. To achieve development goals this individual will foster collaboration with allied functions through outstanding communication, collaboration and coordination. Depending on business needs, the role could include mentorship and management of one or more clinical scientists as well as contribution to business development and continuous improvement activities.

Key Responsibilities:

• Provide clinical development leadership to one or more programs 75%
• Contribute to clinical development strategy in alignment with enterprise goals and management
• Serve as medical monitor for one or more studies
• Perform ongoing clinical trial data review and cleaning in collaboration with clinical science and pharmacovigilance
• Attend and contribute to study team meetings
• Present clinical trial findings to management
• Author clinical documents (protocol, investigator brochure)
• Author clinical portions of regulatory documents (IND, CTA, NDA, MAA or equivalent)
• Develop and manage relationships with key opinion leaders for clinical programs
• Organize, manage and lead Steering Committees and contribute to Strategic or Clinical Advisory Boards
• Contribute to writing of manuscripts, publications, or other documents intended for external audiences
• Contribute in an active and ongoing manner to the scientific, clinical, and commercial development of current and future product candidates
• Contribute to company culture and growth 25%
• Foster communication, collaboration and coordination with other functions
• Contribute to maximizing synergistic collaboration between Ono and Deciphera
• Contribute to assessment of new internal or external targets by outlining clinical challenges and opportunities
• Support Medical Affairs activities as needed
• Participate in and/or coordinate cross-functional continuous improvement projects
• Act as an internal resource for functions requiring clinical input on select drug(s) including primary point of contact for clinical trial staff at study sites for clinical issues as well as regulatory, safety and other functions

Qualifications

• Medical Degree or equivalent with 8+ years of combined relevant academic and industry experience (post-medical school), including 3+ years of work on clinical trials.
• Experience with clinical trial design, conduct, and medical monitoring
• Understanding of GCP/ICH and regional/local regulations
• Familiarity with data review/analytics tools (Rave, J-Review, Spotifre, etc)
• Outstanding leadership, team, presentation, written and oral skills
• Collaborative and flexible in personal interactions at all levels of the company
• Ability to work proactively and effectively, with exceptional creative problem-solving skills
• Excellent strategic planning, organizational and communication skills
• Willingness to accommodate meetings across time zones as needed for project success
• Up to 30% travel

Preferred Capabilities

• Board certification in Nuerology
• Experience in phases 3 of clinical development
• Experience interacting with FDA and regulatory agencies outside of the USA
• Experience in basic or translational science

Additional Information

Deciphera is committed to fair and equitable compensation practices. The base salary pay range for this role is $248,000-$341,000. 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. 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.