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Company

myGwork - LGBTQ+ Business Community · 4 days ago

Director of Study Management, Obesity Programs

Utica-Rome Area

Full-time

Remote

Director/Executive

$162K/yr - $269K/yr

14+ years exp

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Responsibilities

Set objectives for and manage multiple projects and the ongoing work activities within a Global Business Unit/Global Operating Unit.

Act as a single, authoritative source of study information and leads study level status reporting per organizational norms and expectations.

Lead the study team and associated deliverables across all functions; accountable for managing and driving overall study timelines, budgets and quality targets to meet or exceed business needs.

Accountable to ensure effective study team scheduling, records and communications.

Accountable for strategic planning, decision making at the study level in line with program objectives.

Utilize negotiation, facilitation, meeting management and conflict resolution skills to enhance cross-functional study team performance and accountable for effective study team operations.

Represent clinical operations on the asset level teams as per the organizational expectations and asset team charter, serve as a single point of accountability for operational delivery of clinical programs.

Lead clinical operations' sub-team(s) where appropriate, e.g. for large programs with multiple studies, in accordance with the organizational expectations and asset team charter.

Define optimal operational strategy and define timeline, resourcing and budget needs for execution of the clinical plan for the asset/program including early development candidates, concept plans (such as in support of the lifecycle and operating plan process) and for the licensing and partnership opportunities.

Establish and ensure adherence to operational standards and best practices for the asset or program.

Serve as a member of the business unit due diligence team for business development opportunities.

Partner with business unit leaders to assess development program timelines and budgets to inform the assessment of opportunities for the category.

Review annual individual objectives and development plans and perform periodic performance evaluation of direct reports following global or local corporate policy.

Qualification

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Obesity trialsGCP knowledgeStudy/project managementBudget managementLeadership experience

Required

Bachelor's Degree (BA/BS) and 14+ years of experience.

Current experience overseeing Obesity trials IS required for this role.

Knowledge of GCP and a good understanding of the processes associated with study/project management, monitoring, clinical and regulatory operations.

Well-developed planning, observation, analytical and problem-solving skills.

Preferred

Master's (MS) degree and 12+ years relevant pharmaceutical experience.

Doctorate (PhD/PharmD) and 9+ years of experience.

Detail oriented & possesses technical expertise (e.g., spreadsheets, metrics & data flow management).

Exceptional interpersonal skills, including ability to persuade, negotiate and moderate conflict.

Successful experience working with outside vendors contracted to perform clinical operations activities desired.

Experienced with ownership of budgets.

Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.