Job Description

The Senior Manager External Relationships, Business Operations, Clinical Operations, is accountable for clinical program oversight of studies operationalized by Client company’ business partners and is essential to building and maintaining the collaborative relationship with parties outside of Client company. This role partners with Clinical Operations Study Management and Commercial to define overall strategy and execution towards achieving/ exceeding program goals of enhancing diversity of clinical trial populations. As an ad hoc member of the Disease Area and Product Strategy Teams, Sr Manager External Relationships contributes to the development and implementation of the Clinical Development Plan (CDP). The role will also lead and support a range of Business Operations initiatives. This position is remote or if in bay area in-house/hybrid, depending on prior experience. This position will report to the Head of Business Operations.

Responsibilities

• Makes broad contribution at strategic level including input into risk management plans, business value assessment and therapeutic area indication expertise. Provides strategic operational guidance to ensure trials are properly defined, planned, and executed.
• Accountable for operational strategic planning, program strategy, resourcing, budgeting, project plans, and oversight for clinical studies operationalized by Client company business partners.
• Maintains an overview of status, issues, and proactively communicates progress, issues or changes that may impact timelines and costs of the program to all stakeholders. Maintains internal consistency across studies within a program, business partner, and in alignment with functional standards across programs.
• Establishes and maintains collaborative relationships with Client company’ business partner Clinical Operations counterparts.
• Collaborates effectively with internal and external partners; ensures alignment of operational program to the development team’s goals.
• Reviews and contributes to clinical protocols, ICFs, IBs, study manuals/ plans, study reports, diversity plans, and other key operational/ regulatory documents.
• Draft and provide input to governance documents, standard operating procedures, work instructions, training materials, and other clinical quality documents.
• Leads and/or participates in initiatives for process, technology, and other continuous improvement initiatives for time-savings, efficiency, quality, cost-reduction, or other business objectives.
• Collaborates with Commercial team on recruitment materials, branding, and recruitment vendors.
• Leads and/ or participates in engagement calls with focus groups, clinical site staff, or patient advocacy groups.
• Collaborate with cross-functional team execute on plan to increase diversity of Client company clinical trial populations.

Qualifications

• Bachelor’s degree required, preferably in scientific, medical, or healthcare field.
• 10+ years of Clinical Operations experience (8+years for M.S degree) which includes experience in biopharmaceutical clinical trial management, with a focus on oncology.
• Extensive pharmaceutical industry and drug development experience including applicable global regulations and industry guidelines. Oncology therapeutic area experience required.
• Demonstrated effective global clinical program management across phases l-IV. Experience with registrational trials preferred.
• Substantial experience in organization, implementation, and delivery of global clinical programs.
• Thorough understanding of all aspects of clinical drug development, demonstrated experience in strategic planning, demonstrated ability to understand and critically assess the global clinical development plans, protocol design, resource needs, global budgets, and timelines for studies.
• Ability to maintain relevant knowledge of business, regulatory, and therapeutic advances that may impact life cycle planning or ongoing operational strategies.
• Meaningful analytical skills, including previous experience with forecasting and analyzing various sources of data. Ability to analyze complex activities and information to arrive at reasonable conclusions.
• Demonstrated leadership, influencing, communication and strategic project management skills.
• Communicates with energy and passion, to engage and inspire others.
• Demonstrated ability to understand and implement clinical development strategies. Ability to anticipate and resolve problems.
• Demonstrated excellent team and interpersonal skills. Effective communication skills: fluency in verbal and written English, any other language skills may be an asset.
• Ability to work in a self-guided manner with appropriate consultation as needed.

 

Posted On: Monday, April 15, 2024