Clinical Development Director

1 in 375-600 Sickle cell disease is the most common single gene disorder in African Americans, affecting approximately 1 in 375-600 people of African ancestry.

Sickle cell disease is a genetic blood disorder, caused by a single missense mutation, which early on progresses into a systemic disease.

At Novartis, we are committed to treating both the serious manifestations of sickle cell disease, as well as use new exciting technologies to potentially cure this heartbreaking disease.

The Clinical Development Director (CDD) in the Global Health Development Unit is responsible for leading the strategic planning and management of the Sickle Cell program from an end-to-end clinical development perspective. As a CDD, you will have oversight of the clinical development for the assigned clinical program(s) and drive the execution of the clinical development plan. In addition, you will enable an empowered organization, which can navigate in a matrix environment and adjust quickly to business needs.

This position can be located in East Hanover, NJ or Basel, Switzerland.

Your responsibilities will include, but not limited to:

- Providing clinical leadership and strategic input for all clinical deliverables in the assigned project or section of a clinical program. Clinical deliverables may include clinical sections of individual protocols or sub studies consistent with the Integrated Development Plans (IDP), clinical data review, program specific standards, clinical components of regulatory documents/registration dossiers, and publications.
- Leading development of clinical sections of trial and program level regulatory documents.
- Driving execution of the section of the clinical program in partnership with global line functions, assigned Global Trial Directors (GTDs), and regional/country medical associates, if applicable.
- Overseeing/conducting ongoing medical and scientific review of clinical trial data with Clinical Scientific Expert(s) with appropriate oversight from Medical Lead.
- Supporting (Sr.) GPCH in ensuring overall safety of the molecule for the assigned section and may be a core member of the Safety Management Team, supporting overall program safety reporting in collaboration with Patient Safety.
- As a clinical expert, supporting the (Sr.) GPCH or CDH in interactions with external and internal stakeholders and decision boards.
- Contributing to scientific training of relevant Novartis stakeholders on the disease area and compound/molecule. May serve as speaker for franchise medical/scientific training and may be the Program Manager of other associates.

**Commitment to Diversity & Inclusion**:

- Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._

**Minimum requirements**
- Bachelors or Advanced degree in life sciences / healthcare (or clinically relevant degree) is required
- PharmD or PhD is strongly preferred
- Minimum 7 years+ experience in clinical research or drug development
- Working knowledge of the assigned disease area is desired with proven ability to interpret, discuss and present efficacy and safety data relating to clinical trial(s) or program level
- Demonstrated ability to establish effective working relationship with key investigators
- Working knowledge of GCP, clinical trial design, statistics, and regulatory and clinical development processes
- Strong communication skills with the ability to work in a cross functional and global organization

Why Novartis?

766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.

We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.

We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity, and flexibility. And we can reinvent what's possible, when we collaborate with courage to tackle the world’s toughest medical challenges aggressively and ambitiously. Because the greatest risk in life, is the risk of never trying

Imagine what you could do here at Novartis

Join our Novartis Network:
**Division**

Global Drug Development

**Business Unit**

GLOBAL HEALTH DU GDD

**Country**

Switzerland

**Work Location**

Basel

**Company/Legal Entity**

Novartis Pharma AG

**Alternative Country 1**

USA

**Functional Area**

Research & Development

**Job Type**

Full Time

**Employment Type**

Regular

**Shift Work**

No

**Early Talent**

No