Director Clinical Development

Location
Boston, Massachusetts
Posted
Sep 28, 2021
Ref
NA-40
Hotbed
Genetown
Required Education
Doctorate/PHD/MD
Position Type
Full time

Location: Boston, USA

Reporting to: Senior Director, Clinical Development

Job Summary

The Director, Clinical Development will be responsible for the strategy and implementation of one or more of the programs in the franchise and for the development of the clinical programes in the program/s for the franchise.

Key Elements and Responsibilities

  • Works in collaboration with the project leadership team to prepare board presentations, external presentations, investor presentations, funding rounds, etc
  • Ensures preclinical data are adequate for the FTIH study start, in collaboration with the early development functions and CSO, to make the transition from pre-clinical to clinical development
  • In partnership with the cross functional study team develops a focused clinical study protocol that meets scientific objectives and can be implemented in the regulatory environment of all participating regions to provide quality data and ensure timely study delivery.
  • Ensures development, review, finalization and delivery of high quality key study documents in order to meet study timelines.
  • Ensures accurate maintenance and archiving of study records
  • Leads/Helps to prepare and submit regulatory documents related to the area of work (Scientific advice applications, pre-INDs, FTIH, advisory meetings, etc). Participates/leads in regulatory meetings. Works closely with the Regulatory team to develop the strategy to present to management
  • Supports feasibility and determines study allocation to appropriate sites, CROs, ensuring efficient use of resources and adherence to strategic initiatives
  • Supports the management of CROs and vendors with clinical operations
  • Ensures adherence to Good Clinical Practice and all applicable local and international regulations. Accountable for timely delivery of scientifically and operationally robust study documents.
  • Helps with SOPs, study procedures, etc
  • Works closely with the relevant experts ensuring the right data is being generated for the programmes in development (assay validation, right endpoints, endpoint validation, study design, comparator arms, etc)
  • Participates in publication plans and execution, presentation in meetings, congresses, etc
  • Assess signal detection, early safety signals with the medical team
  • Participates in planning medical affairs activities together with the medical team, represents the organization in congreses, patient advocacy groups, etc
  • Works closely with the commercial team working on reimbursement plans, access, etc
  • Works together with the CMO and commercial/legal on presentation/communications
  • Manages the matrix team for the programme/study specfic activities
  • Participates in business development iniciatives for new programes
  • Inputs into the selection of vendors, and works closely with CROs, external partners and contractors/experts
  • Represent the company in key meetings
  • Helps hiring new people and in shaping Orchard’s Clinical team, as the company grows
  • Able to work and navigate the complexities of the academic/biotech interface, working with the academic partners, building relationships

This position will require approximately 20% of time travelling

Required Knowledge

  • Gene therapy, Metabolic diseases, CNS or Immunology Preferably 3+ years in industry
  • Experience in leading a matrix team, vendors and clinical development activities
  • Previous experience in similar position
  • Managerial experience
  • Understanding of the regulatory environment, GCP/ICH and GMP, experience dealing with regulatory agencies, ideally a person who has gone through a regulatory file process
  • Robust understanding of all aspects of clinical development
  • Experience working with complex programmes, ideally experience in gene/cell therapy programmes
  • Mature individual, capable to work independently and make decisions/recommendations to a board/management team
  • Accountable and responsible individual
  • Collaborative working style; the ideal candidate will partner effectively with his colleagues across the organization to seek critical information, constructively challenge plans and assist with the optimal allocation of resource
  • Strategic mindset
  • Excellent organisational skills; the ideal candidate will be able to prioritize activities depending on business imperative and to contibute to several projects in parallel
  • Outstanding presentation skills (Excel, Powerpoint)
  • MD
  • Preferable post-graduate degree +/- relevantpost-graduate qualification
  • Ideally background in gene therapy, metabolic diseases, CNS orimmunology


Skills and Abilities

  • ‘Can-do’ attitude and willingness to be flexible
  • Able to work in a virtual environment
  • Able to manage complex data
  • Able to work in a pressurized environment
  • Able to manage/collaborate with a group of world leader experts

Education

  • MD
  • Preferable post-graduate degree +/- relevant post-graduate qualification
  • Ideally background in gene therapy, metabolic diseases, CNS orimmunology

Orchard is an equal opportunity employer. We recognise and celebrate the diverse culture of our workforce and are committed to creating an inclusive environment for our employees. We fully support the principle of Equality and Diversity in employment and oppose all forms of unlawful or unfair discrimination. We assess all applications on basis of job requirements and individual qualifications.

We work within the requirements of all current legislation and we implement the provisions of regulatory codes of practice in employment.

Notice to All Applicants: Orchard Therapeutics participates in E-Verify


RECRUITERS

All employment offers and CV’s are managed through our Human Resources Department and all candidates are presented through this avenue. Therefore, the Human Resources Department at Orchard Therapeutics requests that recruiters are not to contact Orchard Therapeutics employees directly to present candidates. Complying with this request will be a factor in determining future professional relationships with Orchard Therapeutics. Orchard Therapeutics will not accept unsolicited resumes from any source other than directly from candidates for either current or future positions. Submission of unsolicited resumes in advance of an agreement between the Human Resources Department and the recruiter does not create any implied obligation on the part of Orchard Therapeutics.