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Now Hiring - Pharmaceutical Medicine Development Lead (MDL) in Richmond, VA

Pharmaceutical Medicine Development Lead (MDL) in Richmond, VA

Indivior
Base Salary $141K - $195K
Total Comp: NA
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Qualifications Years In Sales
Industry: Pharmaceutical
Benefits: yes
Customer Size: all
Car Allowance: no
Sales Cycle: Short
Travel: none
Years Selling in Industry:
Education:
They Sell Biotech & Pharmaceuticals
To Whom Pharmaceutical & Biotechnology
Location: Richmond, VA
3.6
TITLE:
Medicine Development Lead (MDL)
Title: Medicine Development Lead (MDL)
Reports To: Senior Vice President, GMD
Location: Richmond, VA
Indivior is a global specialty pharmaceutical company working to help change patients' lives by developing medicines to treat substance use disorders (SUD) and serious mental illnesses. The name is the blend of the words individual and endeavor, and the tagline “Focus on you” makes the company’s commitment clear. It represents and empathizes with the often-difficult journey each individual patient takes to overcome the challenges of addiction and mental illness.
Indivior is dedicated to transforming addiction from a global human crisis to a recognized and treated chronic disease. Our vision is that all patients around the world will have access to evidence-based treatment for the chronic conditions and co-occurring disorders of SUD. The Indivior logo radiates its patient-focused, holistic focus on expanding access to quality treatment for addiction worldwide. Building on its global portfolio of opioid use disorder treatments, Indivior has a pipeline of product candidates designed to both expand on its heritage in this category and potentially address other chronic conditions and co-occurring disorders of SUD, including alcohol use disorder and cannabis use disorder.
POSITION SUMMARY:
The MDL is a senior pharmaceutical professional who leads the Medicines Development Team (MDT) for assigned assets and as such is the primary point of accountability for the asset until approval of a New Drug Application (NDA)/Marketing Approval Application (MAA) or until asset termination. The MDL may continue to support assets with phase 4 planning as member of the Global Brand team (GBT).
ESSENTIAL FUNCTIONS:
The responsibilities of this role include, but are not limited to, the following:
  • Leadership of discovery MDT, early MDT or MDT (dependent on phase of development) leadership team (members of the leadership team dependent on phase of development)
  • Development of global Medicines Development Strategies and Clinical Development Plans for assigned project(s)
  • Accountable for partnering with Global Therapeutic Area Leads (GTAL) and Global Medical Affairs Lead (GMAL) to develop comprehensive end to end medicines development, commercialization, and market access strategies for assigned project(s)
  • Responsible for leading and mentoring the Clinical Team within a project team, also mentors other GMD employees who may not be member of MDT or clinical team
  • Responsible for developing prospective contingency plans for the management of key clinical risks for assigned project(s)
  • Plan, at the earliest stages, coordinate, design, manage, implement, and document clinical studies to ensure that appropriate and accurate clinical data on safety and efficacy are collected, stored, analysed and delivered back to key internal and external customers to meet regulatory and business needs
  • Working with Global Program Manager (GPM), facilitate Lean Sigma project management efficiency processes within clinical development teams
  • Responsible in conjunction with GPM for program finances (setting budgets, managing spend)
  • Help to facilitate drug dependence education (cross-functional) across Indivior
  • Responsible for the content of all clinical sections of the regulatory submissions for assigned project(s)
  • Lead clinical representation for regulatory agency meetings on assigned project(s)
  • Develop and maintain the disease therapy area expertise and scientific excellence required to lead development of assigned assets and support due diligence activities for assets targeting the therapy area of interest
  • Develop relationships with external experts for project level strategic advice. The target is to identify key external partners to work with across the development spectrum of each project
  • Maintain a thorough knowledge of industry expectations and provides guidance and assistance to ensure that Indivior sustains effective and efficient systems in support of global GCP compliant clinical studies and minimizes risks to the company by meeting regulatory standards
  • Update management / internal customers / external customers as appropriate and necessary of clinical research projects and integrate clinical outcomes data with strategic portfolio management
  • Develop and manage interpersonal relationships to influence decisions of senior leaders both within and outside of company
MINIMUM QUALIFICATIONS:
  • An MD, PhD or PharmD degree required
  • Experience in psychiatry or addiction medicine, highly preferred
  • A minimum of 12 years Industry experience in R&D required, with at least 10 years in global clinical development
COMPETENCIES/CONDUCT:
In addition to the minimum qualifications, the employee will demonstrate:
  • Thorough knowledge of utilizing innovative clinical design and/or analysis techniques in global clinical development, within neurosciences (preferably) or other therapeutic areas
  • Advanced understanding of drug development principles and clinical trial implementation and management
  • Demonstrates sufficient knowledge of key functions in development (e.g. toxicology, clinical pharmacology, translational medicine, clinical development, statistics, data management, regulatory, CMC, drug supply, medical, commercial, market access) to contribute to and challenge plans presented to project teams
  • Effective project leadership experience, preferably end to end development
  • Experience in preferably all phases (Phase 0-IV) of development, minimally can demonstrate experience across a number of phases of development such as; evaluation of non-clinical or in-licensing candidates’ potential for meeting an unmet medical need, establishing early clinical safety and proof of concept, conduct of global trials for registration, and implementation of late-stage life-cycle management strategies.
  • Significant understanding of labelling and payer requirements
  • Thorough knowledge of clinical medicine and associated disciplines
  • Advanced understanding of global regulatory requirements, especially US and EU – experience with regulatory in other geographies preferable
  • Ability to work across different therapeutic areas and different stages of clinical development.
  • Demonstrated ability to manage and motivate clinical team members (i.e. internal staff, and external investigators / consultants).
  • Proven track record of leading project and clinical teams; must have strong negotiation and influencing skills
  • Proven track record of effective line and/or matrix management, including development of high performing teams
  • Excellent learning agility and flexibility; excellent written and oral communication skills
BENEFITS:
Indivior is committed to providing a culture driven by guiding principles and top-tier benefits that match the importance of the work we do. The Indivior experience includes
  • 3 weeks’ vacation plus floating holidays and sick leave
  • 401(k) and Profit Sharing Plan- Company match of 75% on your first 6% of contributions discount and profit sharing contribution equal to 4% of your eligible pay
  • U.S. Employee Stock Purchase Plan- 15% Discount
  • Comprehensive Medical, Dental, Vision, Life and Disability coverage
  • Health and Dependent Care Flex Spending options
  • Adoption assistance
  • Tuition reimbursement
  • Leverage Concierge/personal assistance services
  • Voluntary benefits including Legal, Pet Insurance and Auto/Home coverage
  • Gym, fitness facility and cell phone discounts
  • Our Guiding Principles, Core Values and Vision provide a culture that unites and guides our employees.
GUIDING PRINCIPLES:
Indivior’s guiding principles are the foundation for each employee’s success and growth. Each employee is expected to demonstrate understanding and adherence to our guiding principles in their everyday performance.
The duties and responsibilities identified in this position description are considered essential but are not limited to only those outlined. The employee may perform other functions that may be assigned. Management retains the discretion to add or change the duties of this position at any time.
EQUAL EMPLOYMENT OPPORTUNITY
EOE/Minorities/Females/Vet/Disabled
Indivior
Company Size
501 to 1000 Employees
Founded
2014
They Sell
Biotech & Pharmaceuticals
To Whom
Pharmaceutical & Biotechnology
Website
www.indivior.com
Revenue
$1 to $5 billion (USD)

Indivior is currently hiring for 9 sales positions
Indivior has openings in: RI, VA, CT, MI, FL, & WI
The average salary at Indivior is:

9 Yes (amount not posted)

Indivior
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Indivior

Indivior is currently hiring for 9 sales positions
Indivior has openings in: RI, VA, CT, MI, FL, & WI
The average salary at Indivior is:

9 Yes (amount not posted)