AVP, Head of General & Specialty Medicine Clinical Science

Job Description

The Associate Vice President Head of General & Specialty Medicine Clinical Science is the global functional leader for the General & Specialty Medicine Clinical Scientist (CS) organization within General & Specialty Medicine Clinical Development. This role is accountable for setting scientific standards operating model and talent strategy for Clinical Scientists supporting our companys late stage General & Specialty Medicine portfolio across Immunology Cardiovascular & Respiratory Atherosclerosis & Metabolism and Neuroscience.

The Associate Vice President (AVP) ensures that Clinical Scientists deliver consistent high quality scientific and technical oversight of studies and assets partnering closely with Clinical Directors (CDs) Product Development Team Leaders Therapeutic Area Heads Global Clinical Trials operations teams as well as other cross functional partners to advance programs from First-In-Humanthrough registration and lifecycle management.

This role is not asset specific; rather it provides horizontal leadership and governance of clinical scientists across the General & Specialty Medicine portfolio.

Primary Responsibilities:

Functional & Strategic Leadership:

• Serves as the global head of the General & Specialty Medicine Clinical Scientist function with accountability for role clarity scientific quality and consistent execution across all General & Specialty Medicine programs.

• Define and maintain clear role delineation between Clinical Scientists and Clinical Directors aligned with our companys Clinical Development operating model.

• Establish expectations for scientific rigor judgment and decision making appropriate to phase modality and risk.

• Continually optimize organizational design role clarity and resourcing for Clinical Scientists aligned with portfolio priorities.

Clinical Science Standards & Quality:

• Own the clinical scientist framework for General & Specialty Medicine studies including:

  • Optimization of organizational design and resources

  • Ownership and optimization of key processes talent and succession management

• Ensure consistency and quality of CS contributions to:

  • Protocols and amendments

  • Investigator Brochures

  • Medical monitoring and safety plans

  • Regulatory and scientific documents (e.g. INDs briefing packages responses)

• Provide senior scientific input into data interpretation for clinical outcomes safety signal evaluation and benefit risk assessments particularly for complex or high risk programs.

Matrix Partnership & Governance:

• Act as a senior scientific partner to Therapeutic Area Heads and Clinical Development leadership across General & Specialty Medicine.

• Represent the Clinical Scientist function in governance forums review committees and inspection readiness activities as appropriate.

• Partner closely with Clinical Trial Operations teams ensuring seamless work between clinical and operations.

• Partner closely with Regulatory Safety Biostatistics and Translational Medicine to ensure integrated development strategies.

Talent Development & Capability Building:

• Provide vision direction and sponsorship for the General & Specialty Medicine Clinical Scientist organization.

• Ensure robust performance management coaching and career development processes are implemented by CS people leaders.

• Build a strong pipeline of General & Specialty Medicine scientific talent with depth in disease biology modality expertise and clinical judgment.

• Foster a culture of scientific rigor accountability and patient focused development.

Operational Excellence & Inspection Readiness:

• Ensure Clinical Scientist processes support inspection readiness audit outcomes and data integrity.

• Drive continuous improvement informed by inspections internal learnings and external benchmarking.

• Ensure clear escalation pathways for complex scientific and safety issues.

Scope & Reporting:

• Reports into the Senior Vice President Area Head General & Specialty Medicine Clinical Development leadership

• Leads a global General & Specialty Medicine Clinical Scientist organization supporting multiple therapeutic areas and modalities of therapeutics.

• Interfaces routinely with:

  • Therapeutic Area Heads

  • Product development team leads and teams

  • Heads of Clinical Science in other Areas (Oncology ID/Vaccines)

  • Global regulatory and safety partners

  • Global clinical trial operations teams including study managers

  • Finance alliance management compliance legal and other critical functions

Education & Training:

• Minimum requirement: PhD PharmD MD or DO strongly preferred

• 10-15 years of relevant experience in any areas covered by General & Specialty Medicine (Immunology Cardiometabolic Respiratory Neuroscience Metabolism)

Required Experience and Skills:

• Significant experience (>10 years) in General & Specialty Medicine clinical development within a global pharmaceutical or biotech organization.

• Expertise with medical monitoring including medical monitoring.

• Demonstrated leadership of clinical science teams in a matrixed portfolio-based environment.

• Experience working with multiple asset modalities.

• Deep understanding of trial design regulatory expectations and medical oversight across development phases with particular focus for phase 3 studies.

• Experience supporting regulatory interactions inspections and high stakes development decisions.

• US and global filing experience.

• Experience upleveling skills; talent assessment and organizational growth. Experience in building an organization preferred.

• Experience leading CS within a clinical team organization preferred.

Leadership & Competencies:

• Ability to operate effectively at both strategic and executional levels.

• Strong influence skills without direct asset ownership.

• Commitment to patientfocused development scientific excellence and our companys values.

• Expert in teaching/coaching teams and individuals.

• Proven ability to lead crossfunctional strategic and process improvement initiatives.

• Businesssavvy resultsoriented and able to balance rigor speed and risk.

• Strong communication influence and peopledevelopment skills.

Required Skills:

Preferred Skills:

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Effective September 5 2023 employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week Monday - Thursday although the specific days may vary by site or organization with Friday designated as a remote-working day unless business critical tasks require an on-site Hybrid work model does not apply to and daily in-person attendance is required for field-based positions; facility-based manufacturing-based or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note this Hybrid work model guidance also does not apply to roles that have been designated as remote.

The salary range for this role is

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employees position within the salary range will be based on several factors including but not limited to relevant education qualifications certifications experience skills geographic location government requirements and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive if applicable.

We offer a comprehensive package of benefits. Available benefits include medical dental vision healthcare and other insurance benefits (for employee and family) retirement benefits including 401(k) paid holidays vacation and compassionate and sick days. More information about benefits is available at can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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