Clinical Development Medical Director | RE2745

Job Purpose:

• The Clinical Development Medical Director (CDMD) is the clinical leader of defined program level activities (e.g. submission activities, briefing books etc.), or a large, complex trial, under the leadership of the (Sr.) GPCH. May lead a section of a clinical program (e.g., an indication, a new formulation, or a specific development phase).
  

Major Activities:

• 1) Provides clinical leadership and medical strategic input for all clinical deliverables in the assigned project or section of a clinical program if applicable. Clinical deliverables may include clinical sections of individual protocols consistent with the Integrated Development Plans (IDP), clinical data review, program specific standards, clinical components of regulatory documents/registration dossiers, and publications

  2) Leads development of clinical sections of trial and program level regulatory documents (e.g., Investigator’s Brochures, briefing books, safety updates, submission dossiers, and responses to Health Authorities)

  3) Drives execution of the section of the clinical program in partnership with global line functions, assigned Global Trial Directors (GTDs), and regional/country medical associates if applicable

  4) Oversees/conducts ongoing medical and scientific review of clinical trial data with Clincal Scientific Expert(s)

  5) May be the Program Manager of other associates (e.g.., CSE).

  6) May act as study medical monitor

  7) Supports (Sr.) GPCH in ensuring overall safety of the molecule for the assigned section, may be a core member of the Safety Management Team (SMT), and supports overall program safety reporting (e.g., Periodic Safety Update Reports (PSURs), Drug Safety Update Reports (DSURs), and other safety related documents) in collaboration with Patient Safety

  8) Supports the Therapeutic Area Head (TAH) by providing medical input into IDP and CTP reviews and contributing/driving development of disease clinical standards for new disease areas. May take on other TA responsibilities as directed by the TAH

  9) As a medical expert, supports the (Sr.) GPCH or TAH in interactions with external stakeholders (e.g., regulatory authorities, key opinion leaders, data monitoring boards, advisory boards, patient advocacy groups), internal stakeholders (e.g., CTT, Research, Translational Medicine, Global Medical Affairs, Marketing, HE&OR), and internal decision boards

  10) May work with NIBR / Translational Medical Sciences) to drive transition of pre-PoC (Proof of Concept) projects to DDP (Development Decision Point) and with BD&L (Business Development & Licensing) including target identification and due diligences together with other

  medical matters, as needed

  11) Ensures career development of Program reports and other clinical colleagues

  through active participation in the performance management and talent

  planning processes. Provides on-boarding, training, & mentoring support

  12) Contributes to medical/scientific training of relevant stakeholders on the

  disease area and compound/molecule. May serve as speaker for franchise

  medical/scientific training

  13) May serve on or lead global initiatives (e.g., process improvement, training, SOP

  development, other Clinical Development line function initiatives)

KPIs:

• Timely delivery of high quality IDP sections, CTPs, and other clinical deliverables

  aligned with IDP and TPP and endorsed by review committees and internal

  boards, with acceptance by key external and internal stakeholders

  efficacy endpoints, safety assessments, and risk management across disease

  area and development phases

  • Strong evidence of quality medical review of trial data; support TA through high

  quality IDP and protocol reviews; timely development of quality disease/program

  clinical standards, publications, internal/external presentations, and other CD

  deliverables

  • Strong evidence of quality contributions to and acceptance of clinical sections of

  regulatory documents, Investigators’ Brochures, briefing books, safety updates,

  and submission dossiers by key external and internal stakeholders

• Applies effective clinical research methodology, including trial design/analyses,
  • Clearly demonstrates Novartis Values and Behaviours.

Education:
MD or equivalent medical degree required.
Advanced knowledge and clinical training in a medical/scientific area (e.g., internal medicine or sub-specialty) required, with Medical Board certification preferred; Clinical practice experience ≥ 4 years (including residency) preferred

Experience:
· ≥ 5 years of involvement in clinical research or drug development in an academic or industry environment spanning clinical activities in Phases I through IV. ≥ 3 years of contribution to and accomplishment in all aspects of conducting
clinical trials (e.g., planning, executing, reporting and publishing) in a global/matrix environment in pharmaceutical industry
· Advanced knowledge of assigned therapeutic area
· Demonstrated ability to establish strong scientific partnership with key stakeholders
· Thorough knowledge of GCP, clinical trial design, statistical analysis methodology, and regulatory/ clinical development process
· People management experience preferred, this may include management in a matrix environment. Global people management experience desirable
· Excellent communication skills, written and oral
· Strong interpersonal skills
· Excellent negotiation and conflict resolution skills