Tag Archives: NJ

Director Commercial Operations

Director Commercial Operations

Heading Director Commercial Operations
Category

New Jersey

Description
SUMMARY OF POSITIONGlobal Commercial Operations is the central functional interface between the commercial organization and necessary partner functions that are critical for the successful launch planning and commercialization of rare disease drugThe Director / Senior Director, Commercial Operations will lead the commercial planning activities and support the development of the launch plan for the US, EU and ROW.  The execution of the commercialization plan is also a key responsibilityThe Director / Senior Director role advances the global commercialization efforts through cross functional project management activities encompassing planning, execution, and follow-up

Responsibilities include determining and coordinating the commercial planning activities, developing the launch plan, collaborating with finance on the brand budget, managing timelines and ensuring project completion with internal (e.g., Marketing, Program Management, Sales, Commercial Ops, Supply Chain, Medical Affairs, Regulatory, Preclinical, Legal, HEOR, PR/IR, Market Access, Clinical Operations, internal communication) and external stakeholders

MAJOR ACTIVITIES AND RESPONSIBILITIES

Leads the commercial operations activities for the launch planning our lead program

Drive pre-commercial activities, including development of global launch plan and necessary activities critical to the launch plan

Proactively communicate with relevant internal (e.g., Marketing, Program Management, Sales, Commercial Ops, Medical Affairs, Regulatory, Preclinical, Legal, HEOR, PR/IR, Market Access, Clinical Operations, internal communication) and external (e.g., Alliance partners) stakeholders to identify, plan, develop or revise project deliverables which are identified for product or launch success

Tracks and monitors progress of execution of plan

Individual will have significant input into the design, timing and hiring of the commercial organization

Manage communication process for plan development and execution

Identify and highlight critical decision points, events and milestones

Organize and facilitate regular core and extended product team meeting, including coordinating topics/agendas, managing meeting attendees based on agreed upon structure and tracking meeting outcomes and follow-up action items

Build, support and maintain Commercial project management platforms and tool, as central source of information for project deliverables, disease area and brand material, and other relevant information

Lead strategic commercial initiatives, including such activities as commercial forecast modeling, market planning, etc.

Support business development activities, including diligence, as needed

ORGANIZATIONAL STRUCTURE

Reports to the SVP, Business Planning & Development

QUALIFICATIONS AND BACKGROUND REQUIREMENTS

Educational Requirements

BS/BA required (MBA preferred)

Professional Work Experience

Minimum 10 years of related experience in the biotech/pharmaceutical industry

Product launch experience preferred, previous Commercial pharmaceutical experience (sales, marketing, commercial operations, etc.) required

Rare disease experience strongly preferred

Three years strategic consulting, investment banking or related experience preferred

Experience in the design, sequencing and overall hiring of commercial organizations is preferred

Self-motivated, energetic individual who is dedicated to serving the needs of the rare and orphan disease community

Possess a genuine interest in helping to improve the lives of patients and their families who are afflicted with these disorders

Strong understanding of business strategy, marketing planning tools and processes

Exceptional project management skills with ability to manage multiple projects in a cross-functional environment with good understanding of project management process

Strong customer focus with the ability to adapt to internal client needs and expectations

Strong ability to influence outcomes without direct authority and ability to hold oneself and others accountable for commitments

Organized and detail oriented with excellent follow-up abilities

Strong knowledge of key pharmaceutical functions throughout all stages of product development, including Marketing (e.g., Market Research, Market Access), Medical Affairs, Preclinical, Clinical, Regulatory, CMC (e.g. supply chain, drug delivery), etc.

Familiar with Drug Development and Lifecycle Management of pharmaceuticals

Ability to create and deliver effective presentations to working teams and senior management required

Strong communicator and presenter, with the ability to persuade others and foster open communication across internal and external groups

Ability to manage multiple priorities effectively, problem solve, obtain consensus required

Executive Director Corporate & Portfolio Strategy -This position has been filled!

This role can be an Executive Director level for exceptional and senior level candidates

Director Corporate Strategy

Job Responsibilities:

  • Provide thought leadership with respect to enterprise-level strategic topics which may include portfolio composition, capability development, franchise evolution, and resource allocation
  • Assess market dynamics and competitive landscape in order to identify potential implications
  • Identify and develop targeted analytics to inform decision making with focus on annual budget and strategic planning cycles. Analytics will include creation of specific financial scenarios in areas of highest portfolio / market uncertainty
  • Work flexibly with R&D, Medical, Commercial, and Finance stakeholders on above with ability to translate findings into P&L implications

 

Requirements:

  • Bachelor’s Degree in one of the following disciplines: biological sciences, chemistry, physics, statistics, computing science, business (finance, marking, or operations), or engineering
  • 5 or more years experience in a company or academia (or combination) in a function such as market research, strategic planning, finance, marketing, portfolio management or strategic consulting
  • Must understand financial, operational and R&D analytics from a broad range of lenses and be able to apply these to  specific business challenges. Financial experience must include including eNPV analysis and Monte Carlo simulation
  • Significant strategic and/or financial planning experience in oncology is mandatory
  • Adept at reading and understanding external materials such as analyst reports and market research and incorporating/synthesizing relevant components into work products
  • High level of competence in developing executive ready presentations and strong verbal and written communication skills
  • Strong interpersonal skills with demonstrated maturity and ability to think on feet
  • Can-do attitude and ability to work in a highly matrixed and dynamic business environment including ability to interact and communicate to senior level executives

 

 

Vice President, Clinical Research – NJ

Vice President, Clinical Research

SUMMARY OF POSITION

This newly created position will reports to the Chief Medical Officer and will be responsible for managing the clinical, scientific, administrative, and technical activities for the clinical research team. Responsibilities include oversight of the strategy, planning, conduct, and analysis of data from clinical studies, with emphasis on overall clinical study leadership within the Rare Disease space, in line with departmental and corporate goals. This person also ensures quality, timely and coordinated clinical study activities and ensures compliance with the appropriate GCP/ICH and health authority guidelines. This individual provides clinical development expertise on behalf of the company and represents the company at appropriate academic, industry, medical and regulatory meetings.

MAJOR ACTIVITIES AND RESPONSIBILITIES Reporting to the Chief Medical Officer, the Vice President, Clinical Research will;

• Provide leadership to the Clinical Research team involved in the execution of all clinical studies. Responsible for the strategic planning, design, conduct, analysis, and reporting of clinical trials that meet the standards of excellence for ethics, scientific merit, and regulatory compliance, as well as satisfy corporate goals for approval of products.

• Assist senior management to oversee quality, coordination and timeliness of clinical sections of INDs, Investigator Brochures, CTAs, ISS’s, ISE’s, and clinical expert reports.

• Proactively communicates with internal colleagues, and collaborates with peers in other functional areas, and develops and maintains effective relationships with KOLs, medical experts and consultants.

• Represents the company at academic, medical, industry and regulatory meetings.

• Provides guidance on potential business development opportunities

• Provides both day to day management of the members of the Clinical Research team as well as developing their career paths.

• Develops and administers budgets, resource plans and performance objectives for his/her team and area.ORGANIZATIONAL STRUCTURE

The Vice President, Clinical Research reports to the Chief Medical Officer.

QUALIFICATIONS AND BACKGROUND REQUIREMENTS Educational Requirements

• An advanced degree in a relevant field (MD) with experience / knowledge in rare disease clinical research and development preferred. 10 – 12 + years clinical drug development process experience preferred with academic experience as well.

Professional Work Experience

• Knowledge of GCP/ICH guidelines and best practices in Clinical Research and Development. Rare disease experiences preferred.

• Excellent managerial and leadership skills.

• Excellent verbal communication skills to effectively represent the company at a corporate level, with internal working groups/project teams and external academic/industrial/regulatory organizations.

• Excellent written skills. • Team player, possesses sense of urgency, and exhibits potential for mentoring others.

ORGANIZATIONAL/JUDGEMENT:

• Must have planning skills to schedule activities to meet Clinical Research and Development and project team deadlines.

• Possess problem solving ability, and skills to address medical, clinical study and technical questions in a multi-disciplinary environment.

• Must keep abreast of medical and scientific literature within the rare disease area. • Must maintain high ethical standards and integrity at all times.

Competencies:

• Strong leadership skills with an ability to set a vision, to lead change, and to lead and mentor others

• Ability to create and communicate a compelling sense of core purpose and ability to solicit opportunities and possibilities

• Ability to organize, structure and staff the organization in a rapidly changing environment • Strong personal presence with ability to command respect through exercise of sound business

judgment and clear decision-making

• Forward thinker with strong industry knowledge and an ability to identify, synthesize and act upon strategic information and changes within the environment

• Demonstrates a passion for and focus on results with an ability to create excitement and a sense of purpose.

• Excellent communication skills with an ability to efficiently and productively communicate both orally and in writing.

• Excellent interpersonal skills with ability to lead, interact with, influence, resolve conflict and drive consensus among individuals from a variety of cultures, and disciplines.

• Excellent management skills–hiring, recruiting, training, performance management, planning, prioritization, objective setting, meeting management and plan execution.

• Demonstrated decision-making and problem solving capability

Trends in Strategy Consulting – Will the Latest Boom Hinder Career Development

I have been working with strategy and management consultancies since 2005.  I have always enjoyed working with both clients and candidates even though sometimes the process is painful.  There always seem to be 99 things you can measure but the 1 thing you couldn’t quite put a metric always seems to “ding” the candidate.  I have been fortunate to build some great relationships with these professionals and work with them long beyond our first call together.  I have been fortunate to see the complete life cycle – from analyst through promotions, onto b-school and then back to consulting with a chance to make partner or into a great role with an industry company in roles such as Business Development and Licensing, Corporate Strategy, New Product Planning and P&L roles in great organizations.

Never before though has the need for Consultants been more urgent.  Clients are sending more and more work over to Consulting firms and in parallel due to the  biotech boom, clients continue to pick off more and more of more seasoned and critical consultants.

This Consultant human capital scarcity has led to consultancies bumping up the salaries well beyond their traditional hierarchy “grades”.  While this is a short term boon for these employees, it may start to hinder their trajectory and ability to jump off into an industry role as these companies do not feel the urgency of the scarcity and can sometimes fill a role internally with an existing employee.  What it may lead to is Consultants feeling “golden handcuffed” into consulting earlier than ever.