Sr. Clinical Scientist, Clinical Development

R&D Malvern, Pennsylvania


Description

Job Summary - a concise overview of the job

 

The Sr. Clinical Scientist, Clinical Development (CD) is responsible for providing expert clinical advice across all phases (phase II-IV) of clinical research and may consult with the translational study team. In some cases, if instructed by the Chief Scientific Officer), the Sr. Clinical Scientist, Clinical Development (CD) may work on Phase I studies too. This role has the primary responsibility for contributing to CD activities including the design and development of clinical studies, writing various clinical documents such as, but not limited to, clinical study synopsis, clinical study protocol, investigator brochures etc.  Additionally, the Sr. Clinical Scientist may be responsible for leading development programs (an Indication Lead), is adept at strategic thinking, and is responsible for the creation and maintenance of the clinical development plan. Moreover, the Sr. Clinical Scientist is the primary point-of-contact for inquires relating to CD strategy, is responsible for overseeing and guiding the ongoing study data reviews, and providing expert input to the multi-functional, matrixed study and program teams. The Sr. Clinical Scientist is accountable for the on time achievement of study and/or program milestones in alignment with the program team strategic imperatives.

 

All incumbents are responsible for following applicable Division & Company policies and procedures.

Scope of Authority - span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority ( capital, operating, etc.), P&L responsibility, etc.

Endo Branded – domestic and international; reviews budgets; oversees contractors

 

Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of time

Accountability

Key Responsibilities

% of Time

Clinical Lead

§  Lead clinical development scientists for the development and execution of clinical trials under the responsible therapeutic indication.

§  Review, guide and approve protocols, and amendments, ICFs, and clinical sections of other documents.

§  Interact with thought leaders within the respective therapeutic area/indication.

§  Track and update CD team on the CD deliverables across all clinical studies/projects.

§  Lead identifying, contracting and engaging subject matter experts/thought leaders in advisory board meetings, consultancy etc.

§  Oversee regular maintenance and update of the CD project folders/drives.

35%

Clinical Study Planning Development,  Data and Reports

§  Review, guide and finalize study documents such as Protocol Synopses, Protocols, Protocol amendments, Administrative Change letters etc.

§  Ensure CD contributions to trial-related documents such as the IBs, ICF, CRFs, CRF Completion Guidelines, Study Execution and Monitoring Plans, Clinical Data Review Plan, Clinical Database specifications, statistical analysis plan, the data management plan, the medical monitoring plan, Clinical Study Report (CSR) etc.

§  Ensure regular and ad-hoc data reviews and interpretation; preparation of summaries/documentations of these reviews to Senior Director/Director, clinical development.

§  Ensure timely development of program-level documents, including, but not limited to, abstract and manuscripts, presentations, and various other internal and external documents and communications as needed.

35%



Clinical Operations

§  In collaboration with the Development Operations staff, the Sr. Clinical Scientist develops the operational strategies for clinical research studies and development programs including, but not limited to, PI selection, CRO selection, budgets, and timelines.

§  Ensure CD participation in vendor selection, specification development, and management/oversight, as needed.

§  Facilitation of country and site feasibility/selection processes.

§  Ensure development of study specific training materials for study team, investigational sites, and vendors.

§  Participate and present at Investigator meetings or similar.

§  Handle scientific and data-related queries.

§  Collaborate with statistician in data review and interpretations.

15%

Safety & Efficacy

§  Collaborate with the medical monitor and/or clinical safety scientist to identify any trial-related safety trends, and as needed, generate reports to interpret, analyze and summarize the data and trends.

§  Collaborate with the statistician to identify any trial-related efficacy trends, and as needed, generate reports to interpret, analyze and summarize the data and trends.

15%

Total

100%

 

Qualifications

Education & Experience

Minimal acceptable level of education, work experience and  certifications required for the job

§  4-6 years of clinical development experience (pharma, CRO) with an advanced scientific degree (MD or PhD).

§  2-4 years of experience in clinical development within Industry (pharmaceutical, CRO)

§  Previous experience designing and developing phase 1-4 protocols

§  Therapeutic area experience (demonstrable with 2 or more years relevant experience)

§  Demonstrates ability to analyze and interpret data, assess clinical relevance and present/report findings (e.g., ISS, ISE, competitor data, etc.)

§  Experience working on a clinical team.

§  Previous project management/clinical operations experience desirable.


Knowledge

Proficiency in a body of information required for the job    

e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.

§  Demonstrated ability to manage multiple and diverse project concurrently.

§  Demonstrated ability to develop relationships and generate collaborations.

§  Strong analytical skills; a strategic thinker, planner and implementer; proven negotiating track record.

§  Solid Medical/Scientific writing skills required with appropriate clinical, scientific and medical knowledge to author and design and implement clinical protocol and other study documents.

§  Working knowledge of statistics, data analysis and data interpretation.

§  Experience with the operation aspects of clinical trials and related activities such as investigator meetings, DSMB’s and GCP/ICH are necessary.

§  Excellent written and oral communication skills.

§  Organizational and cross functional collaboration skills.

§  Proficient in Microsoft Office Suite of Programs