Product Development Leader - Oncology/Biomarkers | GenomeWeb

Product Development Leader - Oncology/Biomarkers

Organization
Almac Diagnostics
Job Location
4204 Technology Drive
Durham, NC 27724
Salary
Very competitive
Benefits

Generous Health/ Medical Benefits plus 25 days PTO and 12 company holidays

Competitive salary plus bonus

Attractive work environment

Job Description

The Product Development Leader is responsible for overseeing all aspects of the full development of an oncology diagnostics product line from proof of concept in early development through life cycle management. The individual will be responsible for the creation and execution of a full development plan and will lead a cross functional product development team. The Product Development Leader will ensure that the delivery of the diagnostic product is aligned with the overall strategy and goals of Almac Diagnostics.   Responsibilities include:

RESPONSIBILITIES

1. Take responsibility for strategically creating the Diagnostic Product Full Development Plan by:
a. Defining clinical utility and validation strategies by engaging with key internal and external stakeholders
b. Conducting literature searches and coordinating bioinformatics analyses to identify additional indications where the diagnostic product can be utilized
c. Performing required research with key internal stakeholders and external clinicians to identify the design and clinical requirements for the diagnostic assay across different indications

2. Manage and execute the Diagnostic Product Full Development Plan by:
a. Leading the Diagnostic Product Full Development Team
b. Working with Almac technical Operations to ensure timely and high quality product delivery
c. Contributing to the regulatory documents drafting and submission process and participating in regulatory body meetings on an ongoing basis
d. Directing delivery of biostatistics and bioinformatics to accomplish product development
e. Engaging with appropriate external stakeholders, such as KOLs, regulatory entities, and service providers to facilitate generation of clinical and economic evidence to support commercialization

3. Support the development and commercialization of the diagnostic product by:
a. Creating and ensuring adherence to a publication strategy
b. Leading interactions with legal to execute on a patent strategy
c. Engaging with as external partners such as Health Economics, Reimbursement and Financial Model service providers, to generate materials to support product launch, patient and physician education and interpretation of test results
d. Take lead in ensuring that the correct evidence is generated from decision impact or other types of studies to obtain local and /or national reimbursement approvals
e. Working with marketing colleagues for launch and post-launch activities required for the product
f. If appropriate, support the post-commercialization of the product, e.g. further co-development of the product with a partner organization
4. Be a Subject Matter Expert for
a. The scientific and clinical, internal and external research findings that support the rationale for, and the development of, the assay
b. The competitive landscape for the diagnostic product
c. Clinical treatment landscape in particular disease indications under consideration
d. Informing Research regarding unmet needs and areas for new product research and early development.

5. Will be a key contributor for
a. The development, implementation and refinement of an efficient Product Development Process at Almac Diagnostics
b. Evaluation of early stage products for selection to the Development Pipeline by interacting with Research on an ongoing basis

6. May supervise and participate in the career development of Product Development Manager(s) in team

Requirements

• PhD in Biological Sciences with 5 -10 years post-PhD experience; PhD or Postdoctoral training in Oncology, Molecular Biology or Genomics a plus
• Experience in clinical biomarkers and translational research in a Pharmaceutical/Biotechnology or Diagnostics company
• Experience in leading a team or large cross functional project
• Proven experience of:
- Developing and nurturing relationships with external key opinion leaders, collaborators, service providers
- Authoring and reviewing conference presentations and publications
- Representing organization externally by giving scientific presentations
- Good understanding of regulatory landscape for diagnostics across different health authorities
- Knowledge and experience with the patent application process in US or EU

Preferred:
• Experience developing diagnostic assays for commercialization
• Experience as a manager of people in direct line or matrix a plus
• Experience launching a novel product involving state-of-the-art technology for the Life Sciences clinical market
• Regulatory and reimbursement experience
• Experience managing patent strategy globally
• Experience supporting a new product launch
• Experience with engaging with marketing team and outsourcing partners to support commercialization

KEY SKILLS:
• Strong expertise in scientific and translational research and development
• Strong knowledge of clinical treatment landscape in oncology is preferred
• Excellent communication skills (both written and oral)
• Ability to lead a multi-functional team by driving performance
• Skilled at problem solving and creating innovative solutions
• Works collaboratively

How to Apply

Apply on company career site ; email inquires to Corporate Recruiting at

AlmacUSRecruiting@almacgroup.com

About Our Organization

The Almac Group is a family of six business units: Almac Clinical Services, Almac Clinical Technologies, Almac Diagnostics, Almac Discovery, Almac Pharma Services and Almac Sciences. An award winning organization and employer headquartered in Craigavon we also have additional facilities across the UK, the USA, Singapore and Japan.

 

Everything we do supports our core vision: to be the leader in the generation of superior solutions for the advancement of human health. We do this through our four core values: outstanding quality, superlative customer focus, exceptional innovation and inspirational people.

 

Working at Almac is exciting, sometimes challenging but always rewarding. Over a period of sustained global growth spanning in excess of 45 years, the diligence and dedication of our 3700 strong family have made our company the success that it is today.  Together we make an invaluable difference to the health of countless patients all over the world ………and this is just the beginning.

 

Be part of something big.  Be part of something special.  Be part of Almac.

 

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