Director Clinical Sciences
American Cybersystems, Inc.

Job Info

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Innova Solutions client is immediately hiring for a Director Clinical Sciences

Position type: Direct Hire

Location: Remote / Foster City, CA (Local Preferred)

Pay Range (DOE): $185K - $225K

MUST HAVE: Hematology Oncology exp. required

As an Director Clinical Sciences you will:

• Global Clinical Development (CD) Planning: Leads and/or participates in meetings, reviews, discussions and other interactions regarding early development/Phase I studies to provide clinical science input and guidance. Includes contributing to and reviewing of clinical protocols
• Develops the CD plan in collaboration the Clinical Development Physician for selected indication(s)
• Gathers, analyzes and summarized data and information necessary to create the CD plan. May also delegate such research and analysis to less experienced Clinical Scientists
• Leads and/or supports preparation for HA meetings. Participates in HA meetings as required. Ethically, effectively and professionally represents the interests of patients involved in studies
• Stays abreast of internal and external data and developments, trends and other dynamics relevant to the work of CD to maintain, at all times, a fully current view and perspective of internal/external influences and/or implications for the assigned therapeutic and disease area(s)
• Maintains scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment and participates in competitive intelligence assessments as documented in
• Represent Clinical development in collaboration with Research and Translational Sciences for alignment on biomarker strategy and pharmacological assessments
• Clinical Development Plan Implementation: Develops innovative clinical study designs in collaboration with Clinical Development Physicians
• Reviews and/or writes additional clinical science documentation and/or clinical science input into other documentation managed (e.g., protocol summaries, safety monitoring plans, process documents, investigator brochures, etc.)
• Leads the response generation in alignment with Clinical Development Physicians in responding to HA inquiries
• Supports with completion and submission of regulatory filings and other regulatory documentation
• Delivers key presentations, both internally and externally, to convey the CD perspective and provide updates on strategies, plans and other activities. Includes presenting at advisory boards and other relevant external forums representing CRISPR Therapeutics.
• Collaborates with clinical operations, other groups and Medical Directors/Clinical Development Physicians to develop consistent language and criteria for the Informed Consent Form (ICF), protocol eligibility, protocol dose modification, protocol safety, Case Report Forms (CRFs), CRF instructions, etc.
• Collaborates under the leadership of clinical operations to develop and implement the overall data quality plan
• Oversees the review, analysis and reporting of clinical data in collaboration with biometrics and data management to enable clinical decision making and regulatory filings
• Develops and provides input for clinical presentation slides and other materials for internal/external meetings
• Helps to coordinate the successful completion of documents with other groups
• As needed/appropriate, collaborates with others in the review of safety narratives and other safety-related guidelines and documentation
• Participates in safety meetings and tracks, analyzes and reports any potential safety events
• Provides clinical and scientific support with site training, as needed, or requested
• Where assigned, acts as the primary CD liaison/point-of-contact from the team for inquiries from clinical operations, clinical research organizations (CROs), etc.
• Responds to questions from other internal and external parties regarding assigned studies and programs
• Works closely with Clinical Development Physicians, clinical operations and other groups to close-out clinical studies, secure data and complete study reporting
• Participates in the development and implementation of communications strategies to support existing and concluded studies.
• Leads to writing or if applicable writes and/or reviews abstracts, posters, content for scientific meetings, conferences, other events and presentations, and other publicly distributed materials and coordinates further reviews with internal partners and stakeholders. Coordinates submissions to scientific meetings and/or other appropriate venues or groups
• Management/Leadership: Participates in the relevant Clinical Teams
• Represents CD in sub-teams relevant to assigned therapies)/indication(s). May act as the lead CD representative on sub-teams
• Identifies, recruits and manages new clinical science team members and ensures ongoing training and development of Clinical Science personal in conjunction with Development physicians
• Lead relevant sub-teams in assigning and training new team members (with or without direct reporting responsibility)
• Lead aspects of the ongoing enhancements/development of team processes, structures, systems, tools and other resources to ensure sustainable growth and nimbleness

The ideal candidate will have:

• Education, Experience and Qualification Requirements: Advanced scientific or clinical degree (e.g. PhD, PharmD, MPH, etc.).
• 10+ years of relevant clinical trial experience (must demonstrate a minimum of 5 years of high-level clinical trial experience in pharma/biotech industry). Filing experience highly desired. Title to be commensurate with experience and achievement.
• Core Competencies, Knowledge and Skill Requirements: Data listing review experience and familiarity with standard clinical and regulatory references such as CTCAE, MedRa, WHO etc.
• Experience in the principles and techniques of data analysis, interpretation with a solid fundament of statistical principles
• Experience authoring experimental protocols and/or study results and conclusions.
• Relevant therapeutic area experience in hematology or oncology. Experience in immunology is highly beneficial
• In-depth understanding of Phase I (and beyond) drug development.
• Sound knowledge of medical aspects of GCP (Good Clinical Practice), ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use), FDA, EMEA, and other relevant guidelines and regulations.
• Proven abilities to perform Clinical Scientist responsibilities with increasing expertise and independence.
• Track record of working well with other scientists and clinicians and ability to influences without formal reporting relationship across hierarchies and functions
• Ability to travel (30%) domestically and internationally

Qualified candidates should APPLY NOW for immediate consideration! Please hit APPLY to provide the required information, and we will be back in touch as soon as possible.

We are currently interviewing to fill this and other similar positions. If this role is not a fit for you, we do offer a referral bonus program for referrals that we successfully place with our clients, subject to program guidelines. ASK ME HOW.

Thank you!

Preeti Sehgal

Client Services Manager

This job has expired.