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Director of Product Management Document Management and/or eTMF Trial Master File

Company name
Medidata Solutions, Inc.

San Francisco, CA

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Director of Product Management (Document Management and/or eTMF (Trial Master File))

Technology & Analytics San Francisco, California Apply

Medidata is looking for a dynamic Director of Product with responsibility for our document management offering that includes, but not limited to, the following areas:

- Standard Operating Procedures (SOPs) Management

- Electronic Trial Master File (eTMF) Management

- Regulatory Document Workflow & Submission

The Director of Product will be responsible for product strategy, release schedule, building revenue forecasts, managing product budgets, working directly with product owners and business analysts, and generating financial returns for Medidatas document management offering. The product will be built primarily for external users and also integrate with other Medidata offerings to meet each products documentation needs to provide a seamless end to end clinical trial solution. Looking for the challenge of a lifetime while also helping millions of people live happier and healthier lives? The product team at Medidata is looking for a smart, driven Director of Product to help drive the direction and development of our offering, the backbone of which is a recent acquisition of a cloud-based regulated content management and collaboration company that utilizes Box for the underlying platform services. This role will interface with clients and our top architects, analysts, operations, UX, UI, and engineers to define and create an exciting new offering for Medidatas clients and partners.

Your Commitments:

- Participate in defining and owning the product vision and maintain the product roadmap for Medidatas document management solution

- Collaborate with key internal and external stakeholders to develop, deliver, and maintain Medidatas SOP management capabilities

- Define and guide development of Medidatas end to end solution to manage a trials eTMF artifacts, including the leverage of data and information from Medidatas suite of clinical technology products

- Oversee regulatory document submission capabilities including the workflow elements in a documents creation, review and finalization

- Define GTM strategy including market segmentation, key value differentiators, and successful product launches for eTMF based product offerings

- Measure the success of product launches by defining and monitoring key metrics and adoption rates

- Understand market trends, competitive forces, and regional and global industry regulations

- Perform analysis on technical, operational, and market considerations for new product development and differentiation

- Develop pricing strategies and evaluate product positioning to ultimately recommend whether to invest, sustain, or retire functionality or product offerings

- Communicate and collaborate with external clients and partners

- Be the voice of the product owner to managemen

- Support the sales team with sales cycle documentation and presentations

- Present roadmap presentations to clients and partners

- Identify opportunities and execute cross-team product and strategy collaborations

- Perform cost-benefit analyses and recommend plans-of-action to senior management

- Create data-driven revenue goals and propose budget requests to meet said goals

- Contribute to thought-leadership knowledge sharing through internal blogs

- Participate in key client meetings

- Intelligently pull in other stakeholders to help manage customer relationship as needed

- Help drive or lead customer meeting prep across multiple stakeholders

- Work with internal stakeholders to identify how we can expand a customer relationship, and implements said plan across the organization

- Present completed business plans to executives and internal stakeholders to help shape product strategy and gain budget approval

Your Competencies:

- 10 years of relevant experience

- Regulatory document submission knowledge, preferably in the clinical trial space

- Domain knowledge in the development and utilization of eTMF technology in clinical trials

- Experience in workflow development & management

- P & L ownership and/or experience launching new businesses or product offerings

- Demonstrated expertise developing or leading teams which develop products for internal and external use

- Experience with SaaS document management solutions, desirably Box

- Agile experience strongly preferred

- Demonstrable experience of face-to-face working with clients

- Strong written and verbal communication and presentation skills

- General Life Sciences expertise a plus

Your Education & Experience:

- University degree, preferably in business, mathematics, or computer science

- Masters degree strongly preferred

Our Culture: Who we are

We know that creativity doesnt happen on-demand. Developing cutting-edge cloud technology takes great minds and talented people working together in a collaborative environment. That is why we are committed to fostering an innovative, agile company culture. We encourage our teams to come together and experiment with new concepts, research new approaches and test out new technologies. We believe that being part of our team will make a difference in the world.

Our Industry: Where we play

Medidata is making a real difference in the lives of patients everywhere by accelerating critical drug and medical device development. Our work ensures that life-saving drugs and medical devices get to market faster. We are a certified Great Place to Work with highly engaged employees focused on improving the health outcomes of patients across the globe.

We develop cloud-based enterprise products and services and are a world leader driving the convergence of the Technology and Life Sciences industries, one of the most exciting areas for innovation globally. With annual revenue in 2016 of nearly $500 million, we are publicly traded (MDSO) with over 850 customers and customer retention rates above 99%. The Medidata Clinical Cloud is the primary technology solution powering clinical trials for 18 of the worlds top 25 global pharmaceutical companies and is used by 18 of the top 25 medical device developersfrom study design and planning through execution, management and reporting. Our customers include global pharmaceutical companies, biotech, diagnostic and device firms, leading academic medical centers, technical partners and contract research organizations.

By automating over 12,000 clinical trials to date, Medidata has the largest collection of clinical trial data in the world. Today, Medidata pioneers innovative, advanced applications and intelligent data analytics, bringing a new level of quality and efficiency to clinical trials. That means better treatments reach waiting patients sooner.

We know that diverse teams win. It is our diversity and inclusiveness that fuels innovation and sparks our passion and commitment to patient health. We are still led by our Co-founders, Tarek Sherif and Glen de Vries, and have global operations in US, Europe and Asia with over 1900 employees.

Our Mission: Powering smarter treatments and healthier people.

Our Vision: To be the most innovative cloud company in Life Sciences.

Our Principles: Integrity, Partnership, Inventiveness, Humility, Nimbleness, Tenacity, Inclusiveness, and Caring.

Our Leadership Drivers:

- THINK: Inspires purpose, articulates strategy, and simplifies complexity

- TEAM: Communicates effectively, builds relationships and collaborates with others

- DO: Plans ahead, scales for growth, ensures accountability

- LEARN: Self-aware, values difference, strives to learn

- TEACH: Inspires work, coaches others, builds teams

EEO Statement


Medidata Solutions, Inc. is an Equal Opportunity Employer. Medidata Solutions provides equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability status, protected veteran status, or any other characteristic protected by the law. Medidata Solutions complies with applicable state and local laws governing non-discrimination in employment in every location in which the company has facilities.


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Medidata Solutions, Inc.
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