Medical Dir II | B3 | IV

CONTRACT ESTIMATED AT 6 MONTH DURATION. Candidate start as early as 8/11, but sourcing and interviews to start immediately.
*Candidate can be REMOTE, but must EST time zone preferred (candidate can be located elsewhere in US, but may be required to work as early as 7am EST)
Pay range: *** - *** based on qualifications

The Clinical Development Medical Director (CDMD) is the Global clinical leader of defined and assigned program level activities and deliverables (e.g. submission activities, briefing books etc.), or clinical trial(s), under the leadership of the GPCH or Sr CDMD.

MAJOR ACTIVITIES:
1) Provides clinical leadership, scientific and medical strategic input for all clinical deliverables in the assigned or defined program activities as applicable. Clinical deliverables may include (sections of) individual protocols consistent with the Integrated Development Plans (IDP) and CDP, 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 Clinical Trial Heads (CTHs), and regional/country medical associates if applicable

4) Provides medical oversight and leadership of trials and may act as medical monitor. Provides input into final analyses and interpretation including the development of the Clinical Study Report(s) (CSRs), publications and internal/external presentations?

5) Supports GPCH or Sr CDMD in ensuring overall benefit/risk assessment and monitor safety of the molecule for the assigned section on an ongoing basis and 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

6) May be assigned to provide medical input into IDP/CDP and CTP reviews and contributing/driving development of disease clinical standards for new disease areas.

7) As a medical expert, supports the GPCH or CDH/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. As the medical/clinical lead interacts with and represents Client to global key opinion leaders and experts and may lead or co-chair steering committees for defined clinical trials or section of a clinical development program

8) May work with Biomedical Research/Translational Medical Sciences to drive transition of pre-PoC (Proof of Concept) projects to DDP (Development Decision Point) and with Client&L (Business Development & Licensing) including target identification and due diligences together with other medical matters, as assigned by the CDH

9) 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

10)Contributes to medical/scientific training of relevant Client stakeholders on the disease area and compound/molecule. May serve as speaker for franchise medical/scientific training

11) May serve on or lead global initiatives (e.g., process improvement, training, SOP development, other Clinical Development line function initiatives)

12) May be assigned to lead clinical trial(s) as Clinical Scientific Lead and provide leadership and guidance for all clinical aspects of a clinical trial.

KEY PERFORMANCE INDICATORS:
Timely delivery of high quality IDP/CDP sections, CTPs, and other clinical deliverables aligned with IDP/CDP and TPP and endorsed by review committees and internal boards, with acceptance by key external and internal stakeholders
• Applies effective clinical research methodology, including trial design/analyses, efficacy endpoints, safety assessments, and risk management across disease area and development phases
• Strong evidence of quality medical and scientific 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
• Well managed, effective, and engaged clinical teams; demonstrated ability to deputize for GPCH/Sr CDMD at GCT, as well as other venues as needed
• Clearly demonstrates Client Values and Behaviors

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 REQUIRED:
≥ 5 years of involvement in clinical research or global 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. Experience in late phase clinical development preferred
• Solid and advanced scientific acumen and ability to analyze and interpret scientific literature and data
• Advanced knowledge of assigned therapeutic area
• Demonstrated ability to establish strong scientific partnership with key stakeholders
• Thorough knowledge of ICH, GCP, clinical trial design and methodology, statistical analysis methodology, and regulatory/ clinical development process
• 1 year or more of people management experience required, this may include management in a matrix environment. Global people management experience desirable
• Experience with operating and delivering in a complex global matrix environment. and excellent team player
• Excellent communication skills, written and oral
• Excellent interpersonal skills
• Excellent negotiation and conflict resolution skills

ADDITIONAL MANAGER FEEDBACK/NOTES:

*Seeking Clinical Development experience, not just someone with Medical Affairs experience.
*Neuroscience background preferred, especially neurodegenerative diseases
*Experience in Phase 3 clinical trial preparation and start up
*Protocol writing and health authority interactions.