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Clinical Development Lead- Internal Medicine/Liver

Date: Feb 21, 2021

Location: PA, US

Company: Spark Therapeutics

Primary Duties

This individual will be directly, and through their team, responsible for developing global clinical strategies and providing clinical support for early global liver-directed (and other therapeutic areas as necessary) programs in clinical R&D (e.g., program/trial development, site selection and enrollment, investigator engagement, site training, clinical operations). This leader will develop plans that deliver medically differentiated therapies that provide meaningful improvements to patients.  The Clinical Development Lead is a core member of the Asset Team and is responsible for overseeing and developing global Clinical Development (CD) molecule and disease strategies and ensuring effective and efficient execution.  S/he will guide the development of molecules and programs, approve Clinical Development Plans and priorities, and lead the design and final interpretation and completion of clinical studies. This lead will provide clinical support and guidance into global regulatory interactions, will assist the Medical Affairs team, as necessary, and will provide clinical support for strategic planning activities (including clinical advisory boards).  S/He will serve as a scientific, medical, and strategic expert both internally and externally. 

 

Responsibilities

% of Time

Job Function and Description

75%

  • Drive strategy and provide insight for potential new clinical programs and projects based on medical need and development requirements; lead the design of global clinical programs and clinical trial protocols and ensure timely execution of clinical programs.
  • Organize and execute clinical advisory boards to enhance the liver programs.
  • Provide clinical guidance to other R&D groups as needed, regarding nonclinical support, subject eligibility, adverse events, investigator questions, regulatory requests, statistical analyses, study design and conduct, etc.
  • Initiate and develop professional relationships with external clinical opinion leaders, investigators, and consultants and stay abreast of competitive intelligence and other market/industry activities
  • Serve as clinical liaison with investigative sites; engage and support clinical trial sites, including education and training. Participate in site selection activities (including feasibility and initiation visits; other site visits as required) and other trial-related activities to achieve enrollment targets and study timelines
  • Serve as internal as clinical expert for global regulatory interactions; collaborate with Regulatory Affairs in planning regulatory strategy and communications
  • Participate in development and review of clinical documents, including position papers, protocols, study reports, regulatory documents (IND, NDA, MAA responses, clinical summaries, safety assessments, etc.)
  • Acts as a regular reviewer/presenter to various internal committees

 

 

15%

  • Provide input to Medical Affairs regarding global publication and launch plans and participate in development of materials (slide decks, posters, manuscripts, abstracts), based on clinical trial data
  • Participate in development, review and/or presentation of clinical data in Training, Managed Care, or other presentations, as needed
  • Provide medical expertise to commercial and global teams, as needed. Participate in advisory boards, support global initiatives; attend scientific meetings/present data as needed
  • Drives and integrates ongoing evidence/data generation, including clinical trials, Medical Affairs studies, Real World Evidence, and other types of evidence.

 

 

 

Other duties as assigned or as business needs require.

Education and Experience Requirements

  •  Board-certified M.D. with relevant medical experience in internal medicine required
  • 10 or more years pharma/biotech industry experience OR is a recognized expert in the field.  A minimum of 4 years industry experience is preferred (exact number of years depending on level)
  • 4 or more years’ experience managing medical/clinical staff
  • 5 or more years’ experience with clinical trials
  • 2 or more years’ experience submitting INDs and/or NDAs/BLAs to regulatory authorities in Europe and/or the U.S.
  • 4 or more years’ experience authoring global clinical development plans
  • 4 or more years’ experience publishing results of clinical drug trials in referred journals
  • In-depth understanding of Phase I – II drug development
  • Multidisciplinary experience in the pharma/biotech industry is strongly preferred (e.g., research, regulatory, clinical operations, business development, commercial operations, etc.)
  • Strong academic/teaching background is strongly preferred
  • Broad experience in the principles and techniques of data analysis, interpretation and clinical relevance (e.g., ISS, ISE, competitor data, etc.)
  • Comprehensive understanding of product and safety profiles
  • In-depth 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, NICE and other relevant guidelines and regulations
  • In-depth understanding of competitive activity in the field

 

 

Manage the team to achieve business goals and objectives.

  • Foster Spark’s Culture.  Role model the Spark Values. Create an environment where team members thrive by living our truths, always in compliance with applicable laws and regulations. Emphasize to employees that “how” they achieve performance objectives is just as important as “what” they accomplish.
  • Hire & Integrate.  Know what skills, experiences and capabilities are needed to achieve current and future business goals. Take an active role in attracting and selecting talent who are inspired by our Mission, Vision and Values.  Consciously create a team with diverse backgrounds, experiences, skill sets and perspectives.  Help new team members successfully integrate into Spark so they can actively contribute and add value as quickly as possible.
  • Manage performance.   Ensure every team member knows what is expected of them, what it takes to be successful, and how they are progressing.  Provide team members with continuous and on-going performance feedback, holding everyone accountable to achieve results while demonstrating the Spark Values. Help team members understand how their work contributes to the overall success of Spark by continuously communicating priorities, decisions and changes; adjusting goals as needed.
  • Develop people.   Understand each individual team member’s career goals. strengths and motivators.  Partner with your employees to identify areas for development, conduct coaching conversations regularly and provide guidance on ways to develop through on the job experiential learning and stretch opportunities.

 

Key Skills, Abilities, and Competencies

 

  • Deep expertise of the drug development and approval process and clinical trial design

 

 

  • Strong communication skills (written and oral); excellent presentation skills required.

 

 

  • Capable of representing Spark professionally with external global opinion leaders, investigators, vendors, regulatory agencies, alliance partners, and others
  • Able to effectively engage with investigative sites and personnel

 

 

  • Ability to work effectively cross-functionally, and to serve as a clinical resource within Spark

 

 

  • Ability to mentor and develop staff with regard to clinical and strategic issues

 

 

  • Strong interpersonal and leadership skills required
  • Ability to stay abreast of internal and external 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 areas

 

 

 

 

 

Complexity and Problem Solving

     

 

•            Self-motivated and detail-oriented with the ability to prioritize and handle multiple projects

•            Ability to plan and think strategically and critically

•            Ability to function as mentor and to develop junior staff

•            Ability to critically evaluate and analyze scientific data and literature

Internal and External Contacts

This role will interact on a regular basis with a variety of internal and external colleagues, including (but not limited to): other internal clinical, non-clinical, regulatory, medical, safety, R&D, and commercial personnel, external vendors (CROs, labs), investigators and investigative sites, consultants, global key opinion leaders, and global regulators.

Other Job Requirements

Global travel required (approximately 30%)