Head of Metabolic / Rare Disease, Clinical Development

The Head of Metabolic / Rare Diseases will report into the Chief Medical Officer. This is a high-profile role and the successful candidate will provide strategic leadership within the therapeutic area franchise and clinical leadership to one or more Clinical Project Teams to ensure the successful design and implementation of Clinical Development Plans. Major areas of responsibility include strategic leadership in the assigned therapeutic area(s), design and ownership of the clinical development plan, KOL liaison and management, clinical trial design, medical monitoring of company-sponsored clinical trials, clinical data analysis, internal and external communication of project information and plans, and contributions to regulatory submissions, publications, and presentations.

Responsibilities

* Participate in critical strategic and tactical decision making * Develop and maintain clinical development plan * Assist in accomplishing department and corporate objectives * Design clinical trials and write/review protocols and other critical study documents (Investigator Brochures, IND submissions, Clinical Study Reports, etc.) * Lead action-oriented project team meetings and periodic project reviews, including setting appropriate agendas with the Project Manager and approving actionable minutes * Identify emerging risks and manage them with the Project Manager and other team members (as appropriate) * Partner with Drug Discovery and nonclinical development to support streamlined nonclinical development and evaluation of new disease targets * Interact with external medical/scientific advisors, thought leaders, and clinical investigators in the therapeutic area and with internal management and drug development staff to prepare/revise/maintain and efficiently execute the drug development plan * Maintain medical/scientific standards, educate team members, and manage Scientific Advisory Boards (SAB) * Involvement in management related meetings, including Leadership Team and other internal oversight committees. * Interact with regulatory agencies in concert with the Regulatory Affairs Department * Partner with internal Patient Advocate and with external patient organizations * Represent project(s) to corporate partners, investors, and clinical investigators – as required * Develop and oversee the project budget with the Project Manager and Finance Department * Act as Medical Monitor and facilitate the effective conduct of company-sponsored clinical trial by: * Delivering high quality scientific presentations on company technology, investigational agents, and/or clinical study issues to investigators and clinical site staff * Providing guidance and/or training for external personnel/parties involved in the clinical studies Developing and maintaining excellent working relationships with investigators * Ensuring that all GCP requirements are consistently met * Performing clinical study data review and analyses * Interact with Pharmacovigilance during clinical trials and participate in Safety Oversight Committee meetings as needed * Mentor  team members, as required * Develop external advocates for the company’s technology, products, and direction * Facilitate, assist and/or participate in the preparation of clinical study manuscripts by investigators, internal personnel, and/or contract writers * Participate in development, submission and presentation of data at scientific conferences * Maintain clinical and technical expertise in the therapeutic area; review scientific journals, attend scientific and key technical meetings, and partner with company medical, research, and commercial teams * Other duties as assigned

Required Skills

* Advanced degree (MD preferred but Pharm D with extensive experience and strong track record will be considered) * Board certification (or equivalent) in metabolic medicine or medical genetics strongly preferred * 7+ years’ clinical research experience obtained in the pharmaceutical industry and excellent knowledge of the rare disease drug development process * Comprehensive and detailed experience of clinical trial design, implementation, and sponsor/site interactions in conduct of clinical trials * Must have experience working in a leadership role within the development project team, e.g. member of a core project team, sub-team leader, etc. * Proven proficiencies with a wide range of data/information: e.g., scientific/clinical, legal/regulatory, business, financial * Strong communication skills (including writing and presentation skills) with success in influencing at all levels cross functionally Compensation and Benefits: Salary range: $252,000 to $333,000/year Benefits: Health Insurance (medical, dental, vision) Life Insurance Short- and Long-Term Disability 401(k) Paid Time Off (PTO)

Tagged as: Life Sciences