Note: The job is a remote job and is open to candidates in USA. Deciphera Pharmaceuticals is a biopharmaceutical company focused on discovering, developing, and commercializing medicines for cancer, neurologic, and autoimmune diseases. The Associate Director, Clinical Science supports clinical development plans by operationalizing studies, monitoring clinical data, reviewing and interpreting study outputs, authoring clinical and regulatory documents, and coordinating with multidisciplinary teams and external stakeholders.
Responsibilities
- 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
- Participate in authoring clinical documents including concept sheets/decks, clinical study protocols, investigator brochures, and regulatory documents
- 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
- 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
Skills
- 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
Benefits
- Equity-based compensation
- Annual performance bonus
- Long-term incentive plan
- Medical insurance
- Dental insurance
- Vision insurance
- 401(k) retirement plan with company match
- Life insurance
- Flexible spending account for either health care and/or dependent care
- Generous parental leave
- Family planning benefits
- Opportunities for personal and professional growth
- Remote work arrangement
Company Overview
Company H1B Sponsorship