Associate Vice President/ Therapeutic Area Head, Translational Medicine- Small Molecule Oncology

Job Description

The Associate Vice President (AVP) will be responsible for leading the Translational Medicine (TMed) Oncology Therapeutic Area (TA) and strategy for Small Molecule assets, bridging the continuum from Discovery Research through Late-Stage Clinical Development. The AVP provides strategic Clinical Pharmacology oversight for the early clinical space, determining and implementing the initial Clinical Pharmacology strategy through proof-of-concept/ pharmacology/ principle and the transition from early to late-stage governance. In addition, responsibility will include the clinical pharmacology support of the Common Technical Document (CTD) and label, including relevant compound/program life-cycle management.

The successful candidate will have an essential strategic and tactical role in overseeing the scientific direction of clinical programs involving Small Molecule assets for Oncology. They are expected to operate in a highly collaborative and matrixed environment, partnering with peers across the company network agnostic of geographic location in the US and globally. The position will also require strong strategic leadership to deepen and expand an already extensive network of key cross-functional partners both within TMed, Discovery, and Global Clinical Development.

The candidate will be expected to understand our company's portfolio and collaborate with Discovery Research, bringing a clinical perspective to the disease biology, identifying target engagement (TE) approaches, leveraging biomarkers (soluble and imaging), supporting programmatic dose selection, and representing TMed at governance for the Oncology Small Molecule portfolio (discovery Therapeutic Area review, early and late-stage clinical governance), and fully supportive of external-based therapeutic opportunities.

The role will require deep scientific and therapeutic-area expertise in Oncology and Clinical Pharmacology, thorough familiarity, and experience with the principles of drug development to ensure compound transition along the pipeline, management experience, and importantly the ability to work with ambiguity and embrace uncertainty. The role will demand critical, timely, independent decision making and requires a high degree of autonomy.

The AVP reports to the Vice President/ Global Head of Translational Medicine and sits on the T-Med leadership team. This leader must have scientific excellence Oncology Clinical Pharmacology with a rich understanding of drug development, leadership, recruitment capabilities, management skills to direct a group of individuals, and excellent communication and collaboration skills to deliver on the Oncology Small Molecule portfolio strategy.

Primary Responsibilities:

• Serve on TMed core leadership team (LT)

• Serves as the deep subject matter expert in Oncology and Clinical Pharmacology

• Oncology Discovery Review core member

• Represent TMed at core governance (early and late stage)

• Provide core TMed input at external licensing committee for Oncology Clinical Pharmacology

• Provide clinical updates at early (Discovery – Translational) governance

• Present and contribute at governance committees (early and late) as required

• Present Oncology Clinical Pharmacology strategy at governance portfolio reviews

• Oversee and provide strategic/ tactical oversight to early development teams in Small Molecule assets Oncology

• Coordinate dose selection and endorsement at late-stage governance Dose Day

• Establish and own Oncology Clinical Pharmacology strategy with other TA Heads (Discovery/ Late-Stage Clinical Development)

• Be intimately familiar with Oncology Clinical Pharmacology in External Space (competitive opportunities and regulatory guidance)

• Contribute to shaping external opportunities for healthy volunteer-enabled clinical pharmacology oncology

• Lead key technical reviews for Oncology Small Molecule assets

• Conduct DRC reviews (protocols, strategy, other)

• Sign off on clinical pharmacology CTD submissions and NDAs

• Regular updates with key cross-functional partners (Discovery/Late-Stage/Regulatory), as well as other disciplines

• Establish novel endpoints for early clinical assessment leveraging experimental medicine paradigms

• Enable clinical leads and TMed co-chairs on early development teams to establish and deliver programmatic strategy

• Responsible for attracting, hiring, developing, and retaining talent within the discipline

• Contribute to shaping TMed department strategy

Education:

• Advanced degree (MD, MD/PhD) with at least 15 years of academic and/or industry (pharma, biomedical research) experience and expert scientific and translational knowledge in Oncology and Clinical Pharmacology required.

Required Experience and Skills:

• Possess a strong scientific profile with a track record of publication in top-tier, peer reviewed journals are a prerequisite for this role, to establish internal credibility with a highly sophisticated scientific team.

• Understanding of systematic discovery approaches (e.g., functional genomics, computational biology, chemical biology).

• Rich understanding of both physiology and pathophysiology in Oncology.

• Demonstrate a strong track record in early clinical drug development, including the principles of clinical pharmacology, biomarkers of target engagement, experimental medicine platforms, early clinical trial designs and conduct, and operational understanding for implementation.

• Strength in delivering results on firm deadlines in support of the pipeline.

• Ability to develop, analyze and communicate scientific information.

• Experience in attracting, developing, and retaining talent.

• Proven ability to build and lead high performance cross-functional teams.

• Strong interpersonal, communication and collaboration skills, and executive presence to successfully engage senior leaders in governance meetings as well as the ability to function in a team environment.

• Strong decision-making skills, weighing advantages, disadvantages, and business impact for rapid decisions.

• Ability to work successfully with ambiguity and embrace uncertainty.

• Demonstrated ability to collaborate and network effectively within a matrixed organization.

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Requisition ID:R266571