Associate Vice President/therapeutic Area Head - Rahway, United States - Merck Sharp & Dohme

Merck Sharp & Dohme

Verified Company

Rahway, United States

4 weeks ago

Posted by:

Mark Lane

beBee recruiter

Description

The Associate Vice President (AVP) will be responsible for leading the Translational Medicine (TMed) Cardiovascular & Respiratory Therapeutic Area and strategy, bridging the continuum from Discovery Research through Late-Stage Clinical Development.

The AVP provides strategic oversight for the early clinical space, determining and implementing the initial clinical 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 role will require deep scientific and therapeutic-area expertise in Translational Cardiovascular & Respiratory, 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.

The leader must have scientific excellence in Translational Cardiopulmonary 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 Cardiovascular & Respiratory portfolio strategy.

Key Responsibilities:

Serve on TMed core leadership team (LT)
CMD Discovery Review core member
Represent TMed at core governance (early and late stage)
Provide core TMed input at external licensing committee for Cardiovascular & Respiratory.
Provide clinical updates at early (Discovery
Translational) governance
Present and contribute at governance committees (early and late) as required
Present Translational Cardiopulmonary strategy at governance portfolio reviews
Oversee and provide strategic and tactical oversight to early development teams in Cardiovascular & Respiratory
Coordinate dose selection and endorsement at latestage governance Dose Day
Establish and own Cardiovascular & Respiratory strategy with other TA Heads (Discovery/Late-Stage)
Lead key technical reviews for Cardiovascular & Respiratory assets
Conduct DRC reviews (protocols, strategy, other)
Sign off on clinical pharmacology CTD submissions and NDAs
Regular updates with key crossfunctional 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 cochairs 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 Minimum Requirements:

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 Cardiology, Pulmonology and/or Critical Care Medicine required.

Required Experience and Skills:

Possess a strong scientific profile with a track record of publication in toptier, 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 Cardiovascular & Respiratory.
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 crossfunctional 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 decisionmaking 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.

NOTICE FOR INTERNAL APPLICANTS
If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geograp