Development Project Director
hace 7 días
Mission:
To steer the R&D project, leading efficiently and effectively the team, and ensuring the delivery of the maximum project value with the approval of the product and its life Cycle management.
The Global R&D Project Leader (PL) is accountable for the development strategy and integrated science story of a molecule through the clinical development stages, including development of life cycle indication.
Global R&D PL provides strategic leadership to the cross-functional Project Team to deliver successful global product strategy aligned with the Target Product Profile.
Functions and responsibilities:
Development & delivery of product/indication strategy
- Defines and drives strategic and scientific value creation including development, approval, growth, and maturity, integrating diverse internal and external perspectives
- Development and delivery of the product Target Product Profiles (TPP) and Target Product Claims (TPC)
- Development and maintenance of integrated product development plans that deliver regulatory approval worldwide (health authority needs) as well as stakeholder and reimbursement (payer) as needed
- Delivering governance-approved business cases within tolerance on time, cost and quality, and working with functional management as required to resolve issues
- Ensuring effective and transparent risk, opportunity, and issue management at strategic, tactical, and operational levels
- Drive innovative and novel ways to accelerate development & maximize value for patients and the company.
- Partners with the Commercial representative to generate, evaluate and deliver optimal commercial strategies to maximize the value of the indication/product
- Ensure appropriate Governance and Compliance and protect Almirall ́s Rights, Data, and Intellectual Property
- Ensure that all Governance/compliance issues are identified, reported, and managed appropriately
- Represents advocates for project to internal and external stakeholders.
- Represent the Project Team (PT) in strategic discussions in front of Governance bodies (RDSC, RDPC, MB and Derma Commission)
- Strong, creative, and visible leadership of a high performing, efficient cross functional team of global functional leaders responsible for the delivery of the indication/product across all clinical development stages (from FiH to regulatory approval).
- Establish and drive an effective PT to drive timely and effective decision making and delivery of agreed objectives, including the use of agile sub-teams
- Active role in development of cross functional talent capable of taking on global roles.
- Works with line managers and senior stakeholders to support effective capability development of all PT members
- Leadership of cross functional issues management teams
- Drives and supports partnership, nurturing a productive working relationship with partner(s)
- In conjunction with Alliance Manager ensure compliance with the partnership agreement
- In line with the contractual arrangements, lead joint teams and manage joint governance across all relevant parties
Education:
- Sciencebased degree (or equivalent)
- PhD and/or MD
- Proficient in spoken and written English
Education and Specific Expertise:
Education:
- MD degree
- Dermatology or immunology speciality is a plus
Specific expertise:
- 7 years experience in pharmaceutical clinical research (Pharma or CRO) with at least part of that being responsible for major aspects of the strategic planning, organization, implementation, and delivery of early development programs, with handson experience in the dermatology area.
Specific expertise:
- Solid experience in pharmaceutical industry ( 15 years) with full understanding of drug development requirements from preclinical to latestage development, coupled with appropriate regulatory (in US and EU) and commercial & market access insights.
- Previous experience years) leading projects/teams in an R&D organization within the pharmaceutical industry and global environment.
Preferred Skills & Competences:
- Analytical and synthetic skills. Ability to simplify complex situations
- Selfmotivation and resilience under pressure.
- Strong communication skills, with the ability to adjust discourse according to audience (i.e. strategic, operations, scientific)
- Experience to work in different cultures
- Good on Impact and Influence
- Excellent written and verbal communication skills as well as proven negotiation, collaboration and interpersonal leadership skills
Values:
-
Care; we listen & empathize, we value diverse perspectives & backgrounds and we help each other succeed.
-
Courage; we challenge the status quo, we take full ownership and we learn from our success & failures
- **Innovation;
-
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