The Sr. Director, Global Medical Affairs- Hemophilia is a critical member of the Medical Affairs and Patient Engagement leadership team and is responsible for defining the Global Medical Affairs vision, contributions to the integrated strategy (which also includes market access and marketing components) & tactics, and integrated evidence plan that support Spark’s late-stage product development and commercialization objectives through Roche. They will serve as a Spark subject matter expert in their respective therapeutic area for Spark/Roche stakeholders.  They will work with the therapeutic area team members to facilitate strategy and tactic development & implementation for relevant assets. They will lead efforts in key opinion leader (KOL) identification and development, analysis and interpretation of clinical results for medical education, presentations and publications, and health economics support.  They will provide strategic guidance for Phase IV and investigator-initiated research activities, assist in evaluation of new business development opportunities, and support clinical trial investigators and trial enrollment as needed.  They will work closely with Spark’s Patient Advocacy team pre-phase 3 and Roche Patient Partnership team phase 3+ to interface with advocacy groups as appropriate as well as other Roche/Genentech colleagues as required.  Incumbent will manage & develop the careers of Medical Affairs therapeutic area team members.

Responsibilities

Work with therapeutic area team members to facilitate strategy and tactic development & implementation for Spark pre-phase 3 assets

Leads and/or coordinates the global medical strategy contributions to the

Roche ‘integrated strategy’ (which also includes market access and marketing components) and/or life cycle strategy for a respective product(s)

Plan and execute medical advisory boards globally as needed to obtain insight for medical affairs activities, as well as gain KOL feedback on commercial, clinical and other activities

Define KOL targets and strategy for medical advocacy development; participate in KOL speaker training activities

Lead data analysis for Medical Affairs and develop integrated evidence plan for pipeline assets when needed, provide strategic guidance for and review of scientific publications and medical education initiatives, HEOR evidence generation, payer presentations

Deliver presentations of Spark data at medical congresses, represent Spark at relevant scientific, clinical and advocacy meetings

Define research areas of interest for potential investigator-initiated research projects

Provide medical oversight of the promotional review process, in conjunction with the Medical Information function

Provide subject matter expertise to all Spark/Roche stakeholders, e.g. Regulatory and Clinical Development activities as needed/appropriate

Provide subject matter expertise and review of materials for Corporate Communications and other corporate functions as needed/appropriate

Provide strategic leadership to US and global/affiliate therapeutic area medical team members

Manage performance of any direct and matrix report(s) and provide continuous and on-going performance feedback for team members, holding every team member accountable to achieve results while demonstrating the Spark Values

Ensure individual objectives align to corporate and functional objectives.

Develop team members’ careers by continually growing employees through challenging experiences, identify areas for development, actively coach, provide development and learning opportunities.

Foster Sparks Culture and lead by example.

Create an environment where team members thrive in Spark’s culture by living our truths, always in compliance with applicable laws and regulations.  Emphasize to team members that how they achieve performance objectives is just as important as what they accomplish.

Provide critical analysis of new business opportunities and potential new product candidates from a clinical perspective; participate in evaluations and due diligence activities

Provide medical/clinical insight into competitive developments

Other duties as assigned

Manage Medical Affairs therapeutic area reports to achieve business goals and objectives.

Foster Spark’s Culture. Role model the Spark Values. Create an environment where team members thrive by living our truths, always in compliance with applicable laws and regulations. Emphasize to employees that “how” they achieve performance objectives is just as important as “what” they accomplish.

Hire & Integrate. Know what skills, experiences and capabilities are needed to achieve current and future business goals. Take an active role in attracting and selecting talent who are inspired by our Mission, Vision and Values.  Consciously create a team with diverse backgrounds, experiences, skill sets and perspectives.  Help new team members successfully integrate into Spark so they can actively contribute and add value as quickly as possible.

Manage performance.   Ensure every team member knows what is expected of them, what it takes to be successful, and how they are progressing.  Provide team members with continuous and on-going performance feedback, holding everyone accountable to achieve results while demonstrating the Spark Values. Help team members understand how their work contributes to the overall success of Spark by continuously communicating priorities, decisions and changes; adjusting goals as needed.

Develop people.  Understand each individual team member’s career goals. strengths and motivators.  Partner with your employees to identify areas for development, conduct coaching conversations regularly and provide guidance on ways to develop through on the job experiential learning and stretch opportunities.

Education and Experience Requirements

*Location of role is Philadelphia based with 3 days a week onsite.

• MD/DO/MBBS/PhD or equivalent required; significant clinical and/or industry therapeutic area experience also required.
• Well established credibility among the therapeutic area community of KOLs preferred
• 7-10 years of global pharmaceutical/biotech industry experience preferred
• Prior management experience in a global environment preferred
• Demonstrated ability to manage and motivate internal and external team members
• Demonstrated experience in multiple phases of prescription biologic/drug development preferred; post-marketing trial exposure required
• Demonstrated successful track record of KOL interactions and relationship development in the relevant therapeutic area space preferred
• Experience with creating and delivering clinical value presentations to payer audiences preferred
• Experience with designing and running post-marketing trials; experience with registries preferred

Key Skills, Abilities, and Competencies

• Understanding of global medical affairs functions and deliverables
• Ability to analyze data and synthesize a compelling scientific narrative tailored to relevant audiences
• Strong written communication and oral presentation skills
• Proficient in Microsoft Office applications preferred

Complexity and Problem Solving

• Ability to plan and think strategically and critically
• Ability to function as a mentor and to develop junior staff; strong leadership skills
• Strong data analyses and complex problem-solving skills; able to critically evaluate, analyze and interpret scientific data and literature

Internal and External Contacts

This role will interact on a regular basis with a variety of internal and external colleagues, including (but not limited to): internal clinical, regulatory, medical, safety, R&D, and commercial personnel, as well as Roche/Genentech colleagues, external vendors, investigators and investigative sites, consultants, global key opinion leaders, and global regulators.

Other Job Requirements

Travel required (up to 40%) including international travel

Spark takes into consideration a combination of candidate’s education, training, and experience as well as the position’s scope and complexity, the discretion and latitude required in the role, and external market and internal value when determining a salary for potential new employees.  The base salary range for this position is currently from $265,800.00 to $398,800.00.