Program Manager, SCRI Strategic Development
GENERAL SUMMARY OF DUTIES:
Serve as a key figure in the development of assigned disease-specific program by serving as primary resource for assigned Program leader(s). Facilitate the development of the disease-specific program including but not limited to: LOI creation, trial design, and providing scientific collaboration with the designated Program leader(s) at SCRI, academic institutional partners,funding partners, and internal SCRI cross-functional teams. Reports to the Director Strategic Development.
KNOWLEDGE, SKILLS & ABILITIES
- Serve a primary representative to the assigned research program(s), facilitate mutually beneficial relationships with internal/external partners, including members of the disease-specific program team, internal cross-functional teams, pharmaceutical study sponsors, and key external thought leaders and investigators.
- Collaborate with cross-functional teams in order to develop and maintain the disease-specific clinical trial pipeline strategy to ensure continued program success.
- Assist the assigned Program leader(s) in creating and drafting concepts [Letters Of Intent (LOI)] for future clinical trials.
- Assist the assigned Program leader(s) in reviewing and finalizing new trial protocols.
- Assist the assigned Program leader(s) in planning program publication strategies.
- Oversee clinical trial development in the assigned disease-specific research program(s) from trial concept design through acceptance of concept for protocol development. Provide Program leader(s) support to ensure time effective delivery of concept development and in the maintenance of study review/ approval documentation as appropriate.
- Create, maintain and distribute disease-specific pipeline and other related reports and identify gaps in program menu on a routine basis. Provide routine reporting of the disease-specific program status to management, including IIT, IST and Services studies.
- Maintain a high degree of awareness of the current scientific state and advancements in relation to the assigned disease-specific program by attendance at relevant symposium, scientific meetings and workshops, and review of key journals.
- Maintain appropriate documentation and tracking of various disease-specific program needs.
- Collaborate with Program leader(s) and external collaborators on disease-specific strategic planning; provide effective leadership in assessments and facilitate the resolution of problems as needed.
- Provide disease-specific mentoring to SCRI team members as needed.
- Develop concept related status reports to communicate with cross-functional teams, academic institutional partners and pharmaceutical funding partners as needed on behalf of the Program leader(s) and SCRI executives.
- Initiate improvements, tools and forms to enhance the efficiency and the quality of the work performed in assigned disease-specific area. Complete complex tasks and ad hoc assignments as assigned by management.
- Provide proactive and creative recommendations on how to meet corporate and role-specific goals and handle identified deviations.
- Communicate and escalate unresolved issues at the appropriate time and to the appropriate level of management.
- Adhere to professional standards and SOPs established for clinical research and develop new SOPs and or Working Practice Guidelines as appropriate. Monitor adherence to company policies and guidelines and acts according to established procedures to ensure all issues are addressed and resolved as required.
- Participate in educational activities and programs.
- Maintain strictest confidentiality.
- Perform related work as required.
- Practice and adhere to the "Code of Conduct" philosophy and "Mission and Value Statement".
- During your employment with SCRI you will be routinely assigned training requirements. You are expected to complete any training assignments by the due date.
- Demonstrated ability to work in a cross-functional, multicultural and international teams.
- Excellent communication, organization and tracking skills; project management experience desirable.
- Working knowledge of scientific principles and medical terminology. Knowledge of oncology is preferable .
- A thorough understanding of clinical research methodology including study design, concept development, protocol writing and preparation is required as is a knowledge of GCP and local regulatory requirements.
- Basic knowledge of Good Clinical Practice and local regulatory requirements Working knowledge of the IND/NDA process acquired through direct experience preferred.
- Knowledge of medical, scientific and clinical research techniques in assigned therapeutic area.
- Demonstrated ability to accurately and effectively evaluate medical/scientific literature and apply this knowledge to study design. Basic understanding of medical aspects of interventional therapies along with willingness to develop in-depth expertise.
EDUCATION AND EXPERIENCE
- Advanced degree or equivalent education/degree in life science/healthcare with at least 2 years experience in clinical research OR Bachelor degree or equivalent education/degree in life science/healthcare with at least 4 years experience in clinical research . Or equivalent experience.
- Research Professional Certification-CCRP or exam eligibility highly preferred
HCA Inc - 14 months ago