Clinical Development Director

  • Contract type Permanent and Temporary - until further notice
  • Place
    Basel
  • Reference 127516-276-1
  • Start date asap
  • Sector Chemistry & Life Sciences
  • Publication date 14.01.2020

You are experienced as Clinical Development (Medical) Director and you are acquainted with Novartis? For our client Novartis - a leading pharmaceutical company situated in Basel - we are contracting a:

Clinical Development Director

Your assignment

The Clinical Development Director (CDD) is the clinical leader of defined program level activities (e.g. submission activities, briefing books etc.), and/ or indication related clinical trial(s), under the leadership of the (Sr.) GPCH. May lead a section of a clinical program (e.g., an indication, a new formulation, or a specific development phase).

Major Activities:
- Provides clinical leadership and strategic input for all clinical deliverables in the assigned project or section of a clinical program if applicable. Clinical deliverables may include clinical sections of individual protocols or substudies consistent with the Integrated Development Plans (IDP), clinical data review, program specific standards, clinical components of regulatory documents/registration dossiers, and publications
- Leads development of clinical sections of trial and program level regulatory documents (e.g., Investigators Brochures, briefing books, safety updates, submission dossiers, and responses to Health Authorities)
- Drives 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
- Oversees/conducts ongoing medical and scientific review of clinical trial data with Clinical Scientific Expert(s) with appropriate oversight from Medical Lead
- May be the Program Manager of other associates (e.g., CSE)
- Supports (Sr.) GPCH in ensuring overall safety of the molecule for the assigned section, may be a core member of the Safety Management Team (SMT), and supports overall program safety reporting (e.g., Periodic Safety Update Reports (PSURs), Drug Safety Update Reports (DSURs), and other safety related documents) in collaboration with Patient Safety
- Supports the Therapeutic Area Head (TAH) by providing medical input into IDP and CTP reviews and contributing/driving development of disease clinical standards for new disease areas. May take on other TA responsibilities as directed by the TAH
- As a clinical expert, supports the (Sr.) GPCH or TAH in interactions with external stakeholders (e.g., regulatory authorities, key opinion leaders, data monitoring boards, advisory boards, patient advocacy groups), internal stakeholders (e.g., CTT, Research, Translational Medicine, Global Medical Affairs, Marketing, HE&OR), and internal decision boards
- May work with NIBR (Novartis Institute of Biomedical Research/ Translational Medical Sciences) to drive transition of pre-PoC (Proof of Concept) projects to DDP (Development Decision Point) and with BD&L (Business Development & Licensing) including target identification and due diligences together with other medical matters, as needed
- Ensures career development of Program reports and other clinical colleagues through active participation in the performance management and talent planning processes. Provides on-boarding, training, & mentoring support
- Contributes to medical/scientific training of relevant Novartis stakeholders on the disease area and compound/molecule. May serve as speaker for franchise medical/scientific training
- May serve on or lead global initiatives (e.g., process improvement, training, SOP development, other Clinical Development line function initiatives)

Your profile

- Advanced degree in life sciences/healthcare (or clinically relevant degree) is required; PharmD, or PhD strongly preferred
- Fluent oral and written English
- 7 years of involvement in clinical research or drug development in an academic or industry environment spanning clinical activities in Phases I through IV.; 3-5 years of contribution to and accomplishment in all aspects of conducting clinical trials (e.g., planning, executing, reporting and publishing) in a global/matrix environment in pharmaceutical industry
- Advanced knowledge of assigned therapeutic area
- Demonstrated ability to establish strong scientific partnership with key stakeholders
- Thorough knowledge of GCP, clinical trial design, statistical analysis methodology, and regulatory/clinical development process
- People management experience preferred, this may include management in a matrix environment. Global people management experience desirable
- Excellent communication skills, written and oral
- Strong interpersonal skills
- Excellent negotiation and conflict resolution skills

Interested?

This multifaceted project provides the opportunity to apply and increase your expert knowledge in one of the largest pharmaceutical companies worldwide. Also the possibility of contract extension is given. To submit your complete CV including diplomas and references just use the button ‘Apply'. We are looking forward receiving your application today!

About Manpower
Manpower Switzerland offers its customers more than 55 years of experience in the recruitment, selection and placement of permanent and temporary staff, as well as in HR solutions. Its network of 50 branches active in all linguistic regions, 20,000 temporary staff, 1,500 permanent placements and over 5,000 clients – including small, medium and large companies – in all sectors of industry make Manpower one of Switzerland’s leading providers of workforce management solutions.
 
Our 3 promises
“We are passionate about what we do. This passion is a motivating and driving force, ensuring excellent placement opportunities for you.”
“We care about the people we work with. Including you. That’s why our collaborations are based on trust.”
“We take on our responsibilities. For you, that means security and exciting prospects.”
 
 

 

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