Clinical Scientist/Sr. Clinical Scientist
Description The Clinical Scientist will work under the supervision of the Sr. Director, Clinical Affairs to participate in diverse drug development activities. The position is intended to provide broad exposure and participation across drug development to allow individual to refine their future career interests. Some of the activities are likely to include preparation of INDs, Clinical Development Plans (CDPs), protocols, and Clinical Study Reports (CSRs), execution of clinical trials, organizing scientific advisory committee meetings and evaluation of new business development opportunities. The Clinical Scientist may serve in various roles including membership on a clinical team and clinical project sub-teams ESSENTIAL JOB FUNCTIONS
Become familiar with the latest thinking regarding mechanism of disease, diagnostic tests, treatment, drug development trends, and regulatory requirements in assigned disease and therapeutic areas.
Conduct literatures searches relevant to the therapeutic area, disease state or prior clinical trials and develop presentations and summaries that will inform clinical development plans or clinical study protocols
Participate in the design and implementation of applicable clinical protocols, data collection systems, and final reports.
Develop and assist in the preparation of documents to support the components of a regulatory submission (i.e. IND Annual reports, Briefing book for pediatric investigational plan
Review and interpret study results as appropriate and dissemination of the results to study investigators, etc).
Prepare clinical publications or provide input into communication and publication development
Participate in due diligence activities in evaluating new opportunities
Collaborate with the medical director and other experts to understand prior research and related studies to inform clinical protocol development and/or assessment of business development opportunities
Coordinate across experts in relevant departments, including regulatory, clinical, pharmacovigilance to initiate and expedite clinical studies.
Collaborate with R&D and other stakeholders to assess requirements for emerging products.
Assist with the management of and input into Scientific Advisory Boards convened to develop drug development strategies as appropriate.
Assist in conducting efforts to obtain external scientific and clinical validation of clinical research protocols.
Assist in establishing links with outside experts to initiate and expedite clinical studies. May include seeking advice from key external experts, regulatory, pricing/reimbursement, and market access experts.
May participate in the tactical execution of the clinical development protocols by providing guidance, input, and implementation support as appropriate. This may include:
Study Management Plan.
Review study budgets and expenses, ensure study related contractual and budgeting issues are upheld and performed
Identification and selection of clinical research centers and investigators. Assist with contract negotiations when necessary
Investigator meetings, advisory boards and other scientific committees
Study risk mitigation and highlight of potential issues and solutions.
EDUCATION AND EXPERIENCE
Pharm.D. or PhD in health sciences with preference for Pharm.D. candidates
2 years of clinical research experience, or demonstrated ability to develop clinical research protocols and effectively manage clinical trials and protocol development plans, preferably in the therapeutic area of the position. Recently graduating Pharm.D. candidates with research background will also be considered
SKILLS AND ABILITIES
Demonstrated ability to work in cross-functional teams and with individuals.
Effective verbal and written communication skills in relating to colleagues and associates at all levels both inside and outside the organization.
Evidence of ability to rapidly learn clinical development role and performance of its associated tasks is required.
DEPOMED COMPETENCIES INCLUDE
Decisions & Judgment
Ownership & Initiative
Adaptability & Change Readiness
Teamwork & Collaboration